CD 004732

Cochrane Database of Systematic Reviews
Surgical techniques for uterine incision and uterine closure at

the time of caesarean section (Review)
Dodd JM, Anderson ER, Gates S, Grivell RM
Dodd JM, Anderson ER, Gates S, Grivell RM.

Surgical techniques for uterine incision and uterine closure at the time of caesarean section.
Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD004732.
DOI: 10.1002/14651858.CD004732.pub3.
www.cochranelibrary.com
Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review)
Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Analysis 1.1. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 1
Febrile morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Mean blood loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Duration of surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Duration of postnatal stay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Wound complications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Analysis 1.6. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional, Outcome 6 Need
for blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Endometritis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Analysis 2.1. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 1
Postoperative febrile morbidity (including endometritis). . . . . . . . . . . . . . . . . . . . 52
Analysis 2.2. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 2 Mean
blood loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Analysis 2.3. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 3 Need
for blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Analysis 2.4. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 4 Maternal
death or serious morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Analysis 2.5. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection, Outcome 5
Duration of surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Analysis 3.1. Comparison 3 Methods of performing the uterine incision: transverse versus cephalad-caudad blunt extension,
Outcome 1 Mean blood loss. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Outcome 2 Need for blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . 56
Outcome 3 Duration of surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Analysis 4.1. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 1 Postoperative febrile
morbidity (including endometritis). . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Analysis 4.2. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 2 Blood loss greater
than 500 mL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Analysis 4.3. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 3 Need for blood
transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review) i
Analysis 4.4. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 4 Wound infection. 59
Analysis 4.5. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 5 Operative procedure
on wound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Analysis 4.6. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 6 Postoperative
anaemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Analysis 4.7. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 7 Complication of
future pregnancy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Analysis 4.8. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 8 Postoperative pain
present. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Analysis 4.9. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 9 Complications post-
op requiring re-laparotomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Analysis 4.10. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 10 Length of hospital
stay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Analysis 4.11. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 11 Death or serious
maternal morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Analysis 4.12. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 12 Maternal
readmission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Analysis 5.1. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 1
Postoperative febrile morbidity (including endometritis). . . . . . . . . . . . . . . . . . . . 65
Analysis 5.2. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 2 Need for
blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Analysis 5.3. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 3 Wound
infection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Analysis 5.4. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 4 Operative
procedure on wound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Postoperative pain present. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Complications post-op requiring re-laparotomy. . . . . . . . . . . . . . . . . . . . . . . 68
Analysis 5.7. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 7 Death or
serious maternal morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Analysis 5.8. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910, Outcome 8 Maternal
readmission. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 71
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review) ii
[Intervention Review]
Surgical techniques for uterine incision and uterine closure at

the time of caesarean section
Jodie M Dodd1 , Elizabeth R Anderson2 , Simon Gates3 , Rosalie M Grivell1

1 Schoolof Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women’s and
Children’s Hospital, Adelaide, Australia. 2 Department of Genito-urinary Medicine, Royal Liverpool University Hospital, Liverpool,
UK. 3 Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, UK
Contact address: Jodie M Dodd, School of Paediatrics and Reproductive Health, Discipline of Obstetrics and Gynaecology, The
University of Adelaide, Women’s and Children’s Hospital, 72 King William Road, Adelaide, South Australia, 5006, Australia.
jodie.dodd@adelaide.edu.au.
Editorial group: Cochrane Pregnancy and Childbirth Group.

Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 7, 2014.
Citation: Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of cae-
sarean section. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD004732. DOI: 10.1002/14651858.CD004732.pub3.
ABSTRACT
Background
Caesarean section is a common operation. Techniques vary depending on both the clinical situation and the preferences of the operator.
Objectives
To compare the effects of 1) different types of uterine incision, 2) methods of performing the uterine incision, 3) suture materials and
technique of uterine closure (including single versus double layer closure of the uterine incision) on maternal health, infant health, and
healthcare resource use.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (1 September 2013) and reference lists of all identified
papers.
Selection criteria
All published, unpublished, and ongoing randomised controlled trials comparing various types and closure of uterine incision during
caesarean section.
Data collection and analysis
Two review authors evaluated trials for inclusion and methodological quality without consideration of their results according to the
stated eligibility criteria and extracted data independently.
Main results
Our search strategy identified 60 studies for consideration, of which 27 randomised trials involving 17,808 women undergoing caesarean
section were included in the review. Overall, the methodological quality of the trials was variable, with 12 of the 27 included trials
adequately describing the randomisation sequence, with less than half describing adequately methods of allocation concealment, and
only six trials indicating blinding of outcome assessors.
Surgical techniques for uterine incision and uterine closure at the time of caesarean section (Review) 1
Two trials compared auto-suture devices with traditional hysterotomy involving 300 women. No statistically significant difference in
febrile morbidity between the stapler and conventional incision groups was apparent (risk ratio (RR) 0.92; 95% confidence interval
(CI) 0.38 to 2.20).
Five studies were included in the review that compared blunt versus sharp dissection when performing the uterine incision involving
2141 women. There were no statistically significant differences identified for the primary outcome febrile morbidity following blunt
or sharp extension of the uterine incision (four studies; 1941 women; RR 0.86; 95% CI 0.70 to 1.05). Mean blood loss (two studies;
1145 women; average mean difference (MD) -55.00 mL; 95% CI -79.48 to -30.52), and the need for blood transfusion (two studies;
1345 women; RR 0.24; 95% CI 0.09 to 0.62) were significantly lower following blunt extension.
A single trial compared transverse with cephalad-caudad blunt extension of the uterine incision, involving 811 women, and while mean
blood loss was reported to be lower following transverse extension (one study; 811 women; MD 42.00 mL; 95% CI 1.31 to 82.69),
the clinical significance of such a small volume difference is of uncertain clinical relevance. There were no other statistically significant
differences identified for the limited outcomes reported.
A single trial comparing chromic catgut with polygactin-910, involving 9544 women reported that catgut closure versus closure with
polygactin was associated with a significant reduction in the need for blood transfusion (one study, 9544 women, RR 0.49, 95% CI
0.32 to 0.76) and a significant reduction in complications requiring re-laparotomy (one study, 9544 women, RR 0.58, 95% CI 0.37
to 0.89).
Nineteen studies were identified comparing single layer with double layer closure of the uterus, with data contributed to the meta-
analyses from 14 studies. There were no statistically significant differences identified for the primary outcome, febrile morbidity (nine
studies; 13,890 women; RR 0.98; 95% CI 0.85 to 1.12). Although the meta-analysis suggested single layer closure was associated with
a reduction in mean blood loss, heterogeneity is high and this limits the clinical applicability of the result. There were no differences
identified in risk of blood transfusion (four studies; 13,571 women; average RR 0.86; 95% CI 0.63 to 1.17; Heterogeneity: Tau² =
0.15; I² = 49%), or other reported clinical outcomes.
Authors’ conclusions
Caesarean section is a common procedure performed on women worldwide. There is increasing evidence that for many techniques,
short-term maternal outcomes are equivalent. Until long-term health effects are known, surgeons should continue to use the techniques
they prefer and currently use.
PLAIN LANGUAGE SUMMARY

Surgical techniques involving the uterus at caesarean section
Caesarean section is a common abdominal operation for surgical delivery of a baby and the placenta. Techniques vary depending
on the clinical situation and surgeon preferences. Safe delivery is important for mother and infant. Any potential reduction of birth
trauma to the infant has to be balanced against increased ill-health for the mother. Factors include not only the duration of the surgical
procedure and maternal blood loss but also maternal postoperative pain, continuing blood loss and development of anaemia, fever and
wound infection. Additional complications can include problems with breastfeeding, passing urine, longer-term fertility problems, and
complications in future pregnancies (uterine rupture) or increased risks associated with future surgery.
The review authors searched the medical literature for randomised controlled trials to inform the most appropriate surgical techniques
to use. Twenty-seven trials involving 17,808 women from a number of different countries contributed to the review. None of these
trials assessed the type of uterine incision (side to side (transverse) lower uterine segment incision versus other types of uterine incision).
Results from 18 randomised trials contributed to reports that single layer closure of the uterine incision was associated with a reduction
in blood loss, and duration of the procedure. In these studies the surgical procedure for entering the abdominal cavity also differed and
could have contributed to blood loss and duration of surgery.
Five trials compared blunt with sharp dissection at the time of the uterine incision (2141 women) and a further two trials auto-suture
devices with standard hysterotomy (300 women). Blunt surgery was associated with a reduction in mean blood loss at the time of
the procedure. The use of an auto-suture instrument did not clearly reduce procedural blood loss but increased the duration of the
procedure. Overall, trials focused on blood loss and duration of the operative procedure rather than clinical outcomes for the women.
The methodological quality of the trials was variable.
BACKGROUND are also associated with a lower incidence of uterine dehiscence or
rupture in subsequent pregnancies (Tahilramaney 1984).
The use of a low vertical uterine incision has been recommended
in certain clinical situations, particularly in delivery of the preterm
Description of the condition
infant, where the lower uterine segment may be poorly formed
Caesarean section is a common major operation performed on and the longitudinal incision may facilitate delivery and reduce
women in the world. Essentially, the operation involves exposing birth trauma by improved surgical access.
the uterus by entering the abdominal cavity through the abdom- A ’classical’ uterine incision involves a vertical (up and down cut)
inal wall. The peritoneal lining of the abdomen is opened and in the upper body of the uterus, and is used more rarely. It may be
the peritoneum covering the uterus is usually also entered. The used when the baby is in a transverse lie (that is, lying across the
bladder is reflected away from the uterus to reduce the chance of mother’s uterus), when the infant is preterm, or if there is an ante-
damage to it during the operation. The uterus is then incised and rior placenta praevia (the placenta lies in the lower segment and on
the baby and placenta delivered. Adequate haemostasis (control of the front wall of the uterus where the lower transverse uterine in-
bleeding) is achieved by closure of the uterine muscle, followed by cision is usually made), but in practice, this incision is rarely used.
closure of the abdominal wall. Haemorrhage is potentially more severe when an upper uterine
segment incision is used, and the repair often requires closure in
three layers as the myometrium (uterine muscle) is thicker in this
Description of the intervention part of the uterus.
Occasionally, a transverse lower segment incision is made, and
There are many possible ways of performing a caesarean section during the operation, the incision needs to be extended in order to
operation, and operative techniques vary widely. The techniques obtain better surgical access, or to facilitate delivery of the infant.
used may depend on many factors, including the clinical situa- In these situations, the incision may be extended vertically in the
tion and the preferences of the operator. Another Cochrane re- midline, into the upper segment of the uterus forming an inverted
view providing an overview of the techniques, indications for cae- (upside-down) T-shaped incision. Alternatively, the incision may
sarean section and postoperative complications, has been pub- be extended vertically from the end of the transverse incision to
lished (Hofmeyr 2008). form a J-shaped incision.
Our review specifically assessed surgical techniques involving the Potential injuries that may occur for the infant during a traumatic
uterus at the time at caesarean section, and included: caesarean birth include fractures, peripheral nerve damage, spinal
1. the type of uterine incision (lower transverse uterine cord injury and subdural haematoma. Any potential reduction of
incision versus other types of uterine incision); birth trauma to the infant has to be balanced against potential in-
2. methods of performing the uterine incision (’sharp’ uterine creased morbidity to the mother such as operative blood loss and
entry versus ’blunt’ uterine entry); postoperative complications. In particular, consideration needs to
3. suturing materials and techniques for the uterus at be given to mode of birth in any subsequent pregnancy. Uterine
caesarean section; and rupture is a significant risk in a subsequent pregnancy or labour,
4. single versus double layer suturing for closing the uterine with estimates of occurrence being 4% to 9% for classical (uter-
incision at caesarean section. ine body, midline) caesarean incision; 4% to 9% for inverted T-
shaped incisions; 1% to 7% for lower uterine segment vertical in-
cisions; and 0.2% to 1.5% for lower uterine segment transverse
How the intervention might work incisions (ACOG 1999). Current ACOG guidelines limit trial of
vaginal birth after caesarean section to women with a lower uter-
ine segment transverse incision, and recommend repeat caesarean
Part one: type of uterine incision at caesarean section birth for women with a prior classical or inverted T-shaped uterine
scar (ACOG 1999). Any consideration of the benefits associated
Part one of this review compares the outcomes of caesarean sections
with a particular uterine incision must also consider the longer-
performed using a transverse lower segment uterine incision with
term risks associated with repeat caesarean.
other types of uterine incision (low vertical, ’classical’, T-shaped
or J-shaped incision).
The transverse (side-to-side) lower segment uterine incision is Part two: methods of performing the uterine incision
widely used in obstetric practice today. This incision has been Part two of this review compares the outcomes of caesarean sec-
favoured because the lower uterine segment is less vascular than tions performed using different methods of incising the uterus
the body of the uterus, and the incision is easier to repair. This (including autostapling and sharp and blunt uterine entry).
leads to a reduction in operative complications, especially haemor- When the uterus is incised at the time of caesarean section, the in-
rhage, and also a reduction in morbidity. Lower segment incisions cision may be made in the centre of the lower uterine segment with
a scalpel and then extended laterally with scissors (’sharp’ uterine women. However, a recent observational study from Canada has
entry) or by digital extension (using the fingers) (’blunt’ uterine suggested that single layer closure of the lower uterine segment
entry). There has been ongoing debate about which of these forms at caesarean section is associated with a four-fold increase in the
of entry results in better maternal and infant outcomes (Rodriguez risk of uterine rupture in a subsequent pregnancy when compared
1994). Theoretical benefits of sharp uterine entry include more with double layer uterine closure (odds ratio 3.95, 95% confidence
rapid delivery of the baby, and a more controlled entry, with less interval 1.35 to 11.49) (Bujold 2002).
likelihood of the incision extending into the broad ligament or
uterine vessels. The ’clean’ incision may also be easier to repair.
Proponents of blunt uterine entry argue that following the tissue
planes reduces blood loss and improves healing, and that dispens- Why it is important to do this review
ing with an instrument improves control over the entry. Caesarean section is a common operation, with many different
Autostapling techniques involve the insertion of staples as the methods of performing the surgery. It is important to assess the
surgical incision is made in order to keep the operating field as benefits and harms associated with these different ways of per-
bloodless as possible (Wilkinson 2006). The Auto Suture Poly forming the surgery.
CS 57 Stapler was developed in the early 1990s. Its aim was to
achieve haemostasis through the placement of a double layer of
absorbable sutures before the uterine incision was made. The tech-
nique may be useful in particular circumstances, for example,
where the woman is infected with HIV, reducing contamination OBJECTIVES
with maternal blood and potentially reducing viral transmission
To compare, using the best available evidence, the effects of:
to the infant.
1. different types of uterine incision;

Part three: suturing materials and techniques for the
uterus 2. different methods of performing the uterine incision;
Part three of this review compares the outcomes of caesarean sec- 3. different materials and techniques for closure of the uterine
tions performed using different materials and techniques for clo- incision; and
sure of the uterine incision.
There are a range of suture materials and techniques used in sur- 4. single versus double layer closure of the uterine incision on
gical procedures, with the choice often resting with the preference maternal or infant health, or both, and health care resource use.
of the operator. For example, some advocate a single continuous
suture to close the uterus, which can be locked or not locked.
Others advocate multiple or interrupted sutures. Depending on METHODS
local resources and preference, different types of suture includ-
ing monofilament and polyfilament/multifilament may be used to
close the uterus.
Criteria for considering studies for this review
Part four: single versus double layer suturing for
closing the uterine incision
Types of studies
Part four of this review compares the outcomes of caesarean sec-
tions performed using single layer closure of the uterine incision All published, unpublished, and ongoing randomised controlled
with those using double layer closure. trials comparing various types of uterine incision and closure of
One specific question about the technique used for uterine closure the uterine incision during caesarean section.
is whether it should be closed with one layer of sutures or two. Tra- We excluded quasi-randomised trials (e.g. those randomised by
ditionally, the transverse lower segment uterine incision is closed date of birth or hospital number) from the analysis. Studies pre-
in two layers (Enkin 2006). Those who advocate double closure sented in abstract form only will not be included until the full
of the uterus cite improved haemostasis and wound healing, and report becomes available to assess methodological quality and rel-
possibly a reduced risk of uterine rupture in a subsequent preg- evance to the scope of the review.
nancy. Single layer closure may be associated with reduced oper-
ating time, less tissue disruption, and less introduction of foreign
suture material into the wound. These potential advantages may Types of participants
translate into reduced operative and postoperative morbidity for Women undergoing caesarean birth.
Types of interventions Outcome measures for the infant (applicable to part one and
1. Transverse lower uterine segment incision versus other types two of the review)
of uterine incision. 1. Neonatal death.
2. Methods of performing the uterine incision (including 2. Birth trauma (as defined by trial authors).
’sharp’ versus ’blunt’ uterine entry; absorbable sutures versus 3. Infant laceration.
scissor or digital extension; direction of dissection (transverse 4. Admission to neonatal intensive care unit and length of stay.
versus cephalad-caudad)).
3. Different materials or techniques, or both, for closure of the
Health service use
uterine incision (including continuous suture versus interrupted
suture). 1. Length of postoperative stay for the woman and infant.
4. Single versus double layer closure of the uterine incision. 2. Readmission to hospital of the woman or infant, or both.
Only outcomes with available data appear in the analysis table.
Only outcome data that were prestated by the review authors have
Types of outcome measures been used.
The methods section of this review is based on a standard template
used by the Cochrane Pregnancy and Chilbirth Group.
Primary outcomes
Postoperative febrile morbidity (as defined by trial authors). Search methods for identification of studies
Secondary outcomes Electronic searches

We searched the Cochrane Pregnancy and Childbirth Group’s
Trials Register by contacting the Trials Search Co-ordinator (1
Outcome measures for the woman September 2013).
The Cochrane Pregnancy and Childbirth Group’s Trials Register
1. Postoperative analgesia requirements (as defined by trial
is maintained by the Trials Search Co-ordinator and contains trials
authors).
identified from:
2. Blood loss (as defined by trial authors).
1. monthly searches of the Cochrane Central Register of
3. Maternal death or serious maternal morbidity (e.g.
Controlled Trials (CENTRAL);
admission to intensive care unit).
2. weekly searches of MEDLINE;
4. Need for blood transfusion.
3. weekly searches of Embase;
5. Wound infection (as defined by trial authors).
4. handsearches of 30 journals and the proceedings of major
6. Wound complications (e.g. operative procedures carried out
conferences;
on the wound; wound haematoma).
5. weekly current awareness alerts for a further 44 journals
7. Postoperative pain (as measured by visual analogue scale or
plus monthly BioMed Central email alerts.
need for additional analgesia).
Details of the search strategies for CENTRAL, MEDLINE and
8. Breastfeeding (at hospital discharge, or as defined by trial
Embase, the list of handsearched journals and conference pro-
authors).
ceedings, and the list of journals reviewed via the current aware-
9. Voiding problems (as defined by trial authors).
ness service can be found in the ‘Specialized Register’ section
10. Duration of surgery.
within the editorial information about the Cochrane Pregnancy
11. Postoperative anaemia (as defined by trial authors).
and Childbirth Group.
12. Thromboembolic disease.
Trials identified through the searching activities described above
13. Complications during the postoperative period requiring
are each assigned to a review topic (or topics). The Trials Search
further surgery (re-laparotomy).
Co-ordinator searches the register for each review using the topic
list rather than keywords.
Longer-term outcome measures for the woman

Searching other resources
1. Future fertility problems.
2. Complications in a future pregnancy (e.g. placenta praevia, We conducted a manual search of the reference lists of all identified
placenta accreta, uterine rupture). papers.
3. Complications at future surgery (e.g. adhesion formation). We did not apply any language restrictions.
Data collection and analysis • low risk of bias (e.g. telephone or central randomisation;
consecutively numbered sealed opaque envelopes);
For the methods used when assessing the trials identified in the
• high risk of bias (open random allocation; unsealed or non-
previous version of this review, see Appendix 1.
opaque envelopes, alternation; date of birth);
For this update we used the following methods when assessing the
• unclear risk of bias.
reports identified by the updated search.
Selection of studies (3.1) Blinding of participants and personnel (checking for

Two review authors independently assessed for inclusion all the possible performance bias)
potential studies we identified as a result of the search strategy. We We described for each included study the methods used, if any, to
resolved any disagreement through discussion or, if required, we blind study participants and personnel from knowledge of which
consulted a third person. intervention a participant received. We considered that studies
were at low risk of bias if they were blinded, or if we judged that the
Data extraction and management lack of blinding was unlikely to affect results. We assessed blinding
separately for different outcomes or classes of outcomes.
We designed a form to extract data. For eligible studies, two review
We assessed the methods as:
authors extracted the data using the agreed form. We resolved
• low, high or unclear risk of bias for participants;
discrepancies through discussion or, if required, we consulted a
• low, high or unclear risk of bias for personnel.
third person. We entered data into Review Manager software (
RevMan 2012) and checked it for accuracy.
When information regarding any of the above was unclear, we
(3.2) Blinding of outcome assessment (checking for possible
planned to contact authors of the original reports to provide fur-
detection bias)
ther details.
We described for each included study the methods used, if any, to
blind outcome assessors from knowledge of which intervention a
Assessment of risk of bias in included studies participant received. We assessed blinding separately for different
Two review authors independently assessed risk of bias for each outcomes or classes of outcomes.
study using the criteria outlined in the Cochrane Handbook for We assessed methods used to blind outcome assessment as:
Systematic Reviews of Interventions (Higgins 2011). We resolved • low, high or unclear risk of bias.
any disagreement by discussion or by involving a third assessor.
(1) Random sequence generation (checking for possible (4) Incomplete outcome data (checking for possible attrition
selection bias) bias due to the amount, nature and handling of incomplete
outcome data)
We described for each included study the method used to generate
the allocation sequence in sufficient detail to allow an assessment We described for each included study, and for each outcome or
of whether it should produce comparable groups. class of outcomes, the completeness of data including attrition and
We assessed the method as: exclusions from the analysis. We stated whether attrition and ex-
• low risk of bias (any truly random process, e.g. random clusions were reported and the numbers included in the analysis at
number table; computer random number generator); each stage (compared with the total randomised participants), rea-
• high risk of bias (any non-random process, e.g. odd or even sons for attrition or exclusion where reported, and whether miss-
date of birth; hospital or clinic record number); ing data were balanced across groups or were related to outcomes.
• unclear risk of bias. Where sufficient information was reported, or could be supplied
by the trial authors, we planned to re-include missing data in the
analyses which we undertook.
(2) Allocation concealment (checking for possible selection We assessed methods as:
bias) • low risk of bias (e.g. no missing outcome data; missing
We described for each included study the method used to con- outcome data balanced across groups);
ceal allocation to interventions prior to assignment and assessed • high risk of bias (e.g. numbers or reasons for missing data
whether intervention allocation could have been foreseen in ad- imbalanced across groups; ‘as treated’ analysis done with
vance of, or during recruitment, or changed after assignment. substantial departure of intervention received from that assigned
We assessed the methods as: at randomisation);
(5) Selective reporting (checking for reporting bias) Unit of analysis issues
We described for each included study how we investigated the
possibility of selective outcome reporting bias and what we found.
We assessed the methods as: Cluster-randomised trials
• low risk of bias (where it is clear that all of the study’s pre-
We planned to include cluster-randomised trials in the analyses
specified outcomes and all expected outcomes of interest to the
along with individually-randomised trials. No cluster-randomised
review have been reported);
trials were identified for this update. In future updates, if identi-
• high risk of bias (where not all the study’s pre-specified
fied and analysed, we will adjust their sample sizes using the meth-
outcomes have been reported; one or more reported primary
ods described in the Handbook [Section 16.3.4] using an estimate
outcomes were not pre-specified; outcomes of interest are
of the intracluster correlation co-efficient (ICC) derived from the
reported incompletely and so cannot be used; study fails to
trial (if possible), from a similar trial or from a study of a similar
include results of a key outcome that would have been expected
population. If we use ICCs from other sources, we will report this
to have been reported);
and conduct sensitivity analyses to investigate the effect of varia-
tion in the ICC. If we identify both cluster-randomised trials and
individually-randomised trials, we plan to synthesise the relevant
(6) Other bias (checking for bias due to problems not information. We will consider it reasonable to combine the re-
covered by (1) to (5) above) sults from both if there is little heterogeneity between the study
designs and the interaction between the effect of intervention and
We described for each included study any important concerns we the choice of randomisation unit is considered to be unlikely.
had about other possible sources of bias. We will also acknowledge heterogeneity in the randomisation unit
We assessed whether each study was free of other problems that and perform a sensitivity analysis to investigate the effects of the
could put it at risk of bias: randomisation unit.
• low risk of other bias;
• high risk of other bias;
• unclear whether there is risk of other bias.
Cross-over trials
Cross-over trials are not an appropriate study design for the inter-
(7) Overall risk of bias ventions considered in this review.
We made explicit judgements about whether studies were at high
risk of bias, according to the criteria given in the Handbook
(Higgins 2011). With reference to (1) to (6) above, we assessed the Dealing with missing data
likely magnitude and direction of the bias and whether we consid- For included studies, we noted levels of attrition. We planned to
ered it likely to impact on the findings. We planned to explore the explore the impact of including studies with high levels of missing
impact of the level of bias through undertaking sensitivity analyses data in the overall assessment of treatment effect by using sensi-
- see Sensitivity analysis. tivity analysis.
For all outcomes, we carried out analyses, as far as possible, on
an intention-to-treat basis, i.e. we attempted to include all partic-
Measures of treatment effect ipants randomised to each group in the analyses, and all partici-
pants were analysed in the group to which they were allocated, re-
gardless of whether or not they received the allocated intervention.
Dichotomous data The denominator for each outcome in each trial was the number
For dichotomous data, we presented results as summary risk ratio randomised minus any participants whose outcomes were known
with 95% confidence intervals. to be missing.
Continuous data Assessment of heterogeneity

For continuous data, we used the mean difference if outcomes We assessed statistical heterogeneity in each meta-analysis using
were measured in the same way between trials. In future updates, the Tau², I² and Chi² statistics. We regarded heterogeneity as sub-
if appropriate, we will use the standardised mean difference to stantial if an I² was greater than 30% and either a Tau² was greater
combine trials that measure the same outcome, but use different than zero, or there was a low P value (less than 0.10) in the Chi²
methods. test for heterogeneity.
Assessment of reporting biases excluded from the analyses in order to assess whether this made
For this update, there were not more than 10 studies in any meta- any difference to the overall result.
analysis. In future updates, if there are 10 or more studies in the
meta-analysis, we will investigate reporting biases (such as publica-
tion bias) using funnel plots. We will assess funnel plot asymmetry
visually. If asymmetry is suggested by a visual assessment, we will RESULTS
perform exploratory analyses to investigate it.
Data synthesis Description of studies

We carried out statistical analysis using the Review Manager soft-
ware (RevMan 2012). We used fixed-effect meta-analysis for com- Results of the search
bining data where it was reasonable to assume that studies were
The search strategy identified 60 studies for consideration in this
estimating the same underlying treatment effect: i.e. where trials
review.
were examining the same intervention, and the trials’ populations
and methods were judged sufficiently similar. If there was clinical
heterogeneity sufficient to expect that the underlying treatment ef- Included studies
fects differed between trials, or if substantial statistical heterogene- Twenty-seven randomised controlled trials, involving 17,808
ity was detected, we used random-effects meta-analysis to produce women undergoing caesarean section were included in this re-
an overall summary, if an average treatment effect across trials was view (Batioglu 1998; Bjorklund 2000; CAESAR 2010; Ceci
considered clinically meaningful. The random-effects summary 2012; CORONIS 2013; Chitra 2004; Cromi 2008; Dani 1998;
was treated as the average range of possible treatment effects and Darj 1999; Ferrari 2001; Gutierrez 2008; Hamar 2007; Hauth
we discussed the clinical implications of treatment effects differing 1992; Hidar 2007; Lal 1988; Magann 2002; Moreira 2002;
between trials. If the average treatment effect was not clinically Poonam 2006; Rodriguez 1994; Sekhavat 2010; Sood 2005;
meaningful, we did not combine trials. Studzinski 2002; Villeneuve 1990; Von Rechenberg 1990; Wallin
If we used random-effects analyses, the results were presented as 1999; Xavier 2005; Yasmin 2011). Information related to longer-
the average treatment effect with 95% confidence intervals, and term follow-up of women was available from the Hauth paper
the estimates of Tau² and I². (Chapman 1997) for the Hauth 1992 trial.
Subgroup analysis and investigation of heterogeneity Types of uterine incision (transverse lower uterine segment
We did not carry out subgroup analysis for this update. incision versus other types of uterine incision)
In future updates, if we identify substantial heterogeneity, we will There were no studies identified making this comparison in rela-
investigate it using subgroup analyses and sensitivity analyses. We tion to type of uterine incision.
will consider whether an overall summary is meaningful, and if it
is, use random-effects analysis to produce it.
Methods of performing the uterine incision (including ’sharp’
We plan to carry out the following subgroup analyses.
versus ’blunt’ uterine entry; absorbable sutures versus
1. Planned (elective procedure, not in labour) versus
scissor or digital extension; direction of blunt dissection:
emergency procedures (procedures performed in labour,
transverse versus cephalad-caudad)
including those women that had intended an ’elective operation“
and now in spontaneous labour). Five studies were included in the review making the comparison
2. Primary versus subsequent caesarean section procedure. between methods of performing the uterine incision (Hidar 2007;
Only the primary outcome will be used in subgroup analysis. Magann 2002; Poonam 2006; Rodriguez 1994; Sekhavat 2010).
We will assess subgroup differences by interaction tests available All compared blunt versus sharp dissection at the time of uter-
within RevMan (RevMan 2012). We will report the results of ine incision, involving women from the United States (Magann
subgroup analyses quoting the Chi² statistic and P value, and the 2002; Rodriguez 1994), Tunisia (Hidar 2007), Nepal (Poonam
interaction test I² value. 2006), and Iran (Sekhavat 2010). Two studies were identified in-
volving the use of the Autosuture Poly CS 57 automatic surgical
stapler compared with standard hysterotomy, involving women
Sensitivity analysis from Canada (Villeneuve 1990) and Switzerland (Von Rechenberg
We planned to carry out sensitivity analyses to explore the effect of 1990). A single study compared the direction of blunt extension of
trial quality assessed by concealment of allocation, high attrition the uterine incision (transverse versus cephalad-caudad), involving
rates (greater than 20%), or both, with poor-quality studies being women from Italy (Cromi 2008). All studies were single centre.
Different materials or techniques, or both, for closure of the Twenty-six studies were excluded from the review, with 14
uterine incision (including continuous suture versus studies using quasi-randomised methods of treatment allocation
interrupted suture) (Ansaloni 2001; Baxter 2008; Behrens 1997; Dargent 1990;
One study was identified that compared continuous suture closure Falls 1958; Gaucherand 2001; Hameed 2004; Heidenreich 1995;
with interrupted suture closure of the uterine incision (Ceci 2012). Hoskins 1991; Kiefer 2008; Lodh 2002; Ohel 1996; Redlich
Women were followed until 24 months postpartum but only ul- 2001; Van Dongen 1989; ). Eleven studies were excluded as the
trasound and hysteroscopic assessments were reported. One study comparisons did not involve surgical techniques on the uterus
was identified that compared two different types of material for (Buhimschi 2006; Decavalas 1997; Doganay 2010; Gedikbasi
closure of the uterine incision (CORONIS 2013). In this study, 2011; Ghezzi 2001; Giacalone 2002; Hohlagschwandtner;
chromic catgut was compared with number 1 polygactin-910 in Malvasi 2011; Moroz 2008; Naki 2011; Ozbay 2011). One study
almost 10,000 women (this closure could be with interrupted or did not utilise intention-to-treat principles for data analysis, and
continuous sutures). it was not possible from the information provided to restore par-
ticipants to their randomised groups (Heimann 2000).
For details of the excluded studies, see the table of Characteristics
Single versus double layer closure of the uterine incision of excluded studies.
Nineteen studies were identified comparing single layer with dou-
ble layer closure of the uterus (Batioglu 1998; Bjorklund 2000; Studies awaiting assessment and ongoing studies
CAESAR 2010; CORONIS 2013; Chitra 2004; Dani 1998; Darj Several reports were identified in abstract form only, with in-
1999; Ferrari 2001; Gutierrez 2008; Hamar 2007; Hauth 1992; sufficient information available to allow assessment for inclu-
Lal 1988; Moreira 2002; Poonam 2006; Sood 2005; Studzinski
sion in this review (Borowski 2007; Hagen 1999; Mazhar 2004;
2002; Wallin 1999; Yasmin 2011; Xavier 2005). These studies
Mukhopadhyay 2000; Pandey 2006; Wojdemann 2010); another
were conducted in Tanzania (Bjorklund 2000), Tunisia (Hidar
trial report is in Polish and is awaiting translation (Belci 2005)
2007), Senegal (Moreira 2002), the United Kingdom (CAESAR (see Studies awaiting classification), In addition, we identified one
2010), United States of America (Hamar 2007; Hauth 1992), In- trial registration (Farajzadeh 2010) (see Characteristics of ongoing
dia (Chitra 2004; Lal 1988; Sood 2005), Nepal (Poonam 2006), studies).
Mexico (Gutierrez 2008), Turkey (Batioglu 1998), Italy (CAESAR
2010; Dani 1998; Ferrari 2001), Poland (Studzinski 2002), Sene-
gal (Moreira 2002), Portugal (Xavier 2005), and Sweden (Darj
1999; Wallin 1999). With the exception of the CAESAR study
Risk of bias in included studies
(CAESAR 2010), and the CORONIS study (CORONIS 2013), Overall, the methodological quality of the trials was variable (see
all were single centre. The study by Yasmin and colleagues (Yasmin Description of studies and Characteristics of included studies).
2011) focused on ultrasound follow-up of the uterine scar, out- There was variable reporting of the prespecified outcomes of the
comes which were not pre-specified in this review. The study by review, with 21 trials presenting information that could be incor-
Dani and colleagues (Dani 1998) reported short-term infant out- porated into the meta-analysis (Batioglu 1998; Bjorklund 2000;
comes after caesarean section, but none of these outcomes were CAESAR 2010; CORONIS 2013; Chitra 2004; Cromi 2008;
prespecified in the review. Ferrari 2001; Gutierrez 2008; Hamar 2007; Hauth 1992; Hidar
For details of the included studies, see the table of Characteristics 2007; Magann 2002; Moreira 2002; Poonam 2006; Rodriguez
of included studies. 1994; Sekhavat 2010; Studzinski 2002; Villeneuve 1990; Von
Rechenberg 1990; Wallin 1999; Xavier 2005).
See Figure 1; and Figure 2 for a summary of ’Risk of bias’ assess-
Excluded studies ments.
Figure 1. ’Risk of bias’ graph: review authors’ judgements about each risk of bias item presented as
percentages across all included studies.
Figure 2. ’Risk of bias’ summary: review authors’ judgements about each risk of bias item for each included
study.
Allocation
Methods of performing the uterine incision (including
While all of the studies were stated to be randomised, the method ’sharp’ versus ’blunt’ uterine entry and absorbable
of randomisation was adequately described in 13 trials as involv- sutures versus scissor or digital extension)
ing either computer-generated randomisation sequences or ta-
bles of random numbers (Bjorklund 2000; CAESAR 2010; Ceci
2012; CORONIS 2013; Cromi 2008; Hauth 1992; Hidar 2007; Automatic stapler versus conventional uterine incision
Magann 2002; Sekhavat 2010; Sood 2005; Villeneuve 1990; Two trials (Villeneuve 1990; Von Rechenberg 1990) compared
Wallin 1999; Xavier 2005). The method of allocation concealment auto-suture devices with traditional hysterotomy involving 300
was assessed as adequate in 13 trials, with 11 utilising sequentially women. It was only possible to combine data from the two trials
numbered, sealed, opaque envelopes (Bjorklund 2000; Darj 1999; included for the primary outcome, febrile morbidity. No statisti-
Ferrari 2001; Hamar 2007; Hauth 1992; Hidar 2007; Magann cally significant difference between the stapler and conventional
2002; Sekhavat 2010; Sood 2005; Villeneuve 1990; Wallin 1999), incision groups was apparent (risk ratio (RR) 0.92, 95% confi-
and two telephone randomisation (CAESAR 2010; CORONIS dence interval (CI) 0.38 to 2.20), Analysis 1.1. Other outcomes
2013). included data from only one study. There is a suggestion of a lower
blood loss in the stapler group in Villeneuve 1990 (mean differ-
ence (MD) -87.00 mL, 95% CI -175.09 to 1.09), Analysis 1.2;
Blinding however, the lack of blinding means that bias in the assessment of
Blinding of outcome assessor was indicated in only six of the trials this outcome cannot be excluded.
(CAESAR 2010; Ceci 2012; Dani 1998; Sood 2005; Wallin 1999;
Xavier 2005). Blinding of both participants and personnel was not
Blunt versus sharp extension of the uterine incision
indicated in any of the included trials. Participants were blinded
in one trial (Sekhavat 2010). Five trials compared blunt with sharp extension of the uterine inci-
sion, involving 2141 women (Hidar 2007; Magann 2002; Poonam
2006; Rodriguez 1994; Sekhavat 2010). There were no statistically
Incomplete outcome data significant differences identified for the primary outcome febrile
morbidity following blunt or sharp extension of the uterine inci-
Most included studies were assessed as at low risk of bias due to
sion (four studies; 1941 women; RR 0.86; 95% CI 0.70 to 1.05),
incomplete outcome data, with three being assessed as unclear risk.
Analysis 2.1. Mean blood loss (two studies; 1145 women; aver-
age MD -55.00 mL; 95% CI -79.48 to -30.52; Heterogeneity:
Tau² = 160.80; I² = 51%), Analysis 2.2, and the need for blood
Selective reporting
transfusion (two studies; 1345 women; RR 0.24; 95% CI 0.09 to
Most included studies were assessed as at low risk of bias for se- 0.62), Analysis 2.3, were significantly lower following blunt ex-
lective reporting, however, four studies were assessed as having an tension, with no other significant differences identified in dura-
unclear risk of selective reporting bias. tion of operative procedure (one study; 200 women; MD -2.80
minutes; 95% CI -5.84 to 0.24), Analysis 2.5, or risk of serious
maternal morbidity (one study; 400 women; RR 3.00; 95% CI
Other potential sources of bias 0.12 to 73.20), Analysis 2.4.
The CEASAR trial was identified as at potential risk of bias, hav-
ing modified the primary outcome of the trial after 600 women
Direction of blunt extension of the uterine incision:
were recruited, and as the trial was stopped short of the total es-
transverse versus cephalad-caudad
timated sample size (CAESAR 2010). The trial by Xavier (Xavier
2005) recruited and randomised 162 women, with outcome data A single trial compared transverse with cephalad-caudad blunt
reported for only 72. extension of the uterine incision, involving 811 women (Cromi
2008). While mean blood loss was reported to be lower following
transverse extension (one study; 811 women; MD 42.00 mL; 95%
Effects of interventions CI 1.31 to 82.69), Analysis 3.1, the clinical significance of such
Twenty-seven randomised controlled trials, involving 17,808 a small volume difference is of uncertain clinical relevance. There
women undergoing caesarean section were included in this review, were no other statistically significant differences identified for the
as described below. limited outcomes reported.
Single versus double layer closure of the uterine While caesarean section is a common procedure performed on
incision women worldwide, there is limited information available to inform
Nineteen studies were identified comparing single layer with dou- the most appropriate surgical technique to adopt. Our review did
ble layer closure of the uterus (Batioglu 1998; Bjorklund 2000; not identify any randomised controlled trials assessing the type
CAESAR 2010; CORONIS 2013; Chitra 2004; Dani 1998; Darj of uterine incision to be used (transverse lower uterine segment
1999; Ferrari 2001; Gutierrez 2008; Hamar 2007; Hauth 1992; incision versus other types of uterine incision), the materials used
Lal 1988; Moreira 2002; Poonam 2006; Sood 2005; Studzinski to suture the uterus, or techniques of suture closure (continuous
2002; Wallin 1999; Yasmin 2011; Xavier 2005), with data con- suture versus interrupted suture; locking versus unlocked suture).
tributed to the meta-analyses from 14 studies. The reported stan- While blunt dissection of the uterine incision was associated with
dard deviations for continuous variables reported in Ferrari 2001 a reduction in the mean blood loss at the procedure and the need
were considered to be far too small to be plausible, and we believe for blood transfusion, there were no other differences identified in
that the authors have erroneously reported standard errors rather clinical outcomes. The use of an auto-suture device was associated
than standard deviations. We have therefore, converted the stan- with a reduction in the mean blood loss at the procedure, but an
dard errors to standard deviations by dividing the square root of increase in the duration of the procedure when compared with
the sample size for inclusion of these data in the analyses. performing a traditional hysterotomy. Similarly, there were no sta-
There were no statistically significant differences identified for the tistically significant differences identified in the clinical outcomes
primary outcome, febrile morbidity (nine studies; 13,890 women; reported.
RR 0.98; 95% CI 0.85 to 1.12), Analysis 4.1. For the outcome Closure of the uterus with chromic catgut was associated with a
of mean blood loss, although the meta-analysis suggested single reduction in blood transfusion and complications requiring re-la-
layer closure sure was associated with a reduction in mean blood parotomy, however, there was no significant difference in any other
loss, heterogeneity is high and this limits the clinical applicability clinical outcomes. The only trial making this comparison allowed
of the result. There were no differences identified in risk of blood surgeons to use any suture technique, i.e. continuous, continuous
transfusion (four studies; 13,571 women; average RR 0.86; 95% locking and interrupted sutures and this is an important potential
CI 0.63 to 1.17; Heterogeneity: Tau² = 0.03; I² = 30%), Analysis confounder for these outcomes.
4.3. There were no other significant differences identified in the Although single layer closure of the uterine incision was associated
reported clinical outcomes. with a reduction in mean blood loss, and duration of the operative
procedure, there were no statistically significant differences iden-
tified in the risk of febrile morbidity and other clinically relevant
Suturing materials and techniques for uterine closure outcomes. Most of the studies involved in this comparison were
(including continuous suture versus interrupted assessing different methods of performing the whole caesarean
suture) section operation (for example, a ”whole procedure“ technique,
One study was identified that compared continuous versus inter- which includes as one aspect the single layer closure versus another
rupted suture closure for the uterine incision (Ceci 2012), how- ”whole procedure technique“ that includes a double layer closure).
ever, no clinical maternal outcomes were reported, with ultrasound Different components of these procedures involve variation in the
and hysteroscopic assessments forming the main focus of the pa- methods used to enter the abdominal cavity, which in turn may
per. The single trial comparing chromic catgut with polygactin- influence the extent of blood loss, and duration of the procedure.
910 reported on outcomes in 9544 women (CORONIS 2013) .
Closure with catgut was associated with a significant reduction in
the need for blood transfusion (one study, 9544 women, RR 0.49, Overall completeness and applicability of
95% CI 0.32 to 0.76), Analysis 5.2. and a significant reduction in evidence
complications requiring re-laparotomy (one study, 9544 women,
Overall, reporting of the prespecified review outcomes was poor,
RR 0.58, 95% CI 0.37 to 0.89); Analysis 5.6. There were no other
with the majority of trials focusing on estimates of mean blood
significant differences in the other reported outcomes.
loss and duration of the operative procedure, rather than measures
It was not possible to conduct the planned subgroup analyses.
reflecting health outcomes. For many of the outcomes, reporting
was from a single trial, with relatively small combined sample size.
DISCUSSION
Quality of the evidence
Overall, the methodological quality of the trials was variable, with
12 of the 27 included trials adequately describing the randomisa-
Summary of main results
tion sequence, with less than half describing adequately methods
of allocation concealment, and only six trials indicating blinding Caesarean section is a common procedure performed on women
of outcome assessors. worldwide. There is increasing evidence that for many techniques,
short-term maternal outcomes are equivalent. Until long-term
health effects are known, surgeons should continue to use the tech-
Agreements and disagreements with other niques they prefer and currently use.
studies or reviews
Implications for research
The literature describing and assessing caesarean section surgical
techniques is broad and in general of low quality, and as such the Future randomised controlled trials and future follow-up of
current review is in general agreement with most other studies and women in existing trials should address:
reviews in this area.
• the most appropriate uterine incision;
• the optimal suture technique to close the uterus;
• the value of blunt compared with sharp uterine dissection;
AUTHORS’ CONCLUSIONS and
• the value of single compared with double layer uterine
Implications for practice
closure.
Despite caesarean section being a common operation, for many
aspects of the procedure, there is limited high quality information Any future randomised trials should be adequately powered to
available to suggest that one surgical technique is superior to an- detect important differences in clinically relevant outcomes.
other. There is no information available to inform the most ap-
propriate uterine incision. There is little information to support
the most appropriate method of performing the uterine incision
(blunt versus sharp dissection) or to support the use of an auto-
ACKNOWLEDGEMENTS
suture device. There is limited information available to inform
the optimal suture technique for the uterine incision. Consider- As part of the pre-publication editorial process, this review has
ation should be given to suture material for uterine closure, as been commented on by six peers (an editor and five referees who
closure with chromic catgut was associated with a lower risk of are external to the editorial team), a member of the Pregnancy
blood transfusion, when compared with polygactin-910, with no and Childbirth Group’s international panel of consumers and a
difference in other clinical outcomes. statistician.
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BMC Pregnancy and Childbirth 2007;7:24.
Transverse uterine incision closure: one vs two layers.
Cromi 2008 {published data only} American Journal of Obstetrics and Gynecology 1992;166:
Cromi A, Di Naro E, Siesto G, Uccella S, Caringella A, 398.
Uboldi V, et al. Expansion of uterine incision at cesarean
Hidar 2007 {published data only}
delivery: a randomized comparison of two techniques.
Hidar S, Jerbi M, Hafsa A, Slama A, Bibi M, Khairi H. The
American Journal of Obstetrics and Gynecology 2007;197(6
effect of uterine incision expansion at caesarean delivery
Suppl 1):S36, Abstract no: 79.
on perioperative haemorrhage: a prospective randomised
∗
Cromi A, Ghezzi F, Di Naro E, Siesto G, Loverro G,
clinical trial. Revue Medicale de Liege 2007;62(4):235–8.
Bolis P. Blunt expansion of the low transverse uterine
incision at cesarean delivery: a randomized comparison of 2 Lal 1988 {published data only}
techniques. American Journal of Obstetrics and Gynecology Lal K, Tsomo P. Comparative study of single layer and
2008;199(3):292.e1–6. conventional closure of uterine incision in cesarean section.
Dani 1998 {published data only} International Journal of Gynecology & Obstetrics 1988;27:
Dani C, Reali M, Oliveto R, Temporin G, Bertini G, 349–52.
Rubaltelli F. Short-term outcome of newborn infants born Magann 2002 {published data only}
by a modified procedure of cesarean section: a prospective ∗
Magann E, Chauhan S, Bufkin L, Field K, Roberts W,
randomized study. Acta Obstetricia et Gynecologica Martin JP Jr. Intra-operative haemorrhage by blunt verus
Scandinavica 1998;77:929–31. sharp expansion of the uterine incision at caesarean delivery:
Darj 1999 {published data only} a randomised clinical trial. BJOG: an international journal
Darj E, Nordstrom ML. The misgav ladach method for of obstetrics and gynaecology 2002;109:448–52.
cesarean section compared to the pfannenstiel method. Acta Magann E, Chauhan S, Bufkin L, Fields K, Roberts W,
Obstetricia et Gynecologica Scandinavica 1999;78(1):37–41. Martin JJ. Sharp versus blunt expansion of the uterine
incision: influence on blood loss [abstract]. American
Ferrari 2001 {published data only} Journal of Obstetrics and Gynecology 2001;184(1):S18.
Ferrari A, Frigerio L, Candotti G, Buscaglia M, Petrone M,
Taglioretti A, et al. Can Joel-Cohen incision and single Moreira 2002 {published data only}
layer reconstruction reduce cesarean section morbidity?. Moreira P, Moreau JC, Faye ME, Ka S, Kane Gueye SM,
International Journal of Gynecology & Obstetrics 2001;72: Faye EO, et al. Comparison of two cesarean techniques:
135–43. classic versus misgav ladach cesarean [Comparaison de
deux techniques de cesarienne: cesarienne classique
Gutierrez 2008 {published data only}
versus cesarienne Misgav Ladach]. Journal de Gynecologie,
Gutierrez JG, Colo JA, Arreola MS. Comparative trial
Obstetrique et Biologie de la Reproduction 2002;31(6):572–6.
between traditional cesarean section and Misgav-Ladach
technique [Comparación entre cesarea Misgav–Ladach y Poonam 2006 {published data only}
cesarea tradicional]. Ginecologia y Obstetricia de Mexico Poonam, Banerjee B, Singh SN, Raina A. The Misgav
2008;76(2):75–80. Ladach method: a step forward in the operative technique
of caesarean section. Kathmandu University Medical Journal Yasmin 2011 {published data only}
2006;4(2):198–202. Yasmin S, Sadaf J, Fatima N. Impact of methods for uterine
incision closure on repeat caesarean section scar of lower
Rodriguez 1994 {published data only}
uterine segment. Jcpsp, Journal of the College of Physicians &
Rodriguez A, Porter KB, O’Brien WF. Digital vs
Surgeons - Pakistan 2011;21(9):522–6.
instrumental expansion of the uterine incision at the time of
a low segment transverse cesarean section. American Journal References to studies excluded from this review
of Obstetrics and Gynecology 1994;170:339.
∗
Rodriguez AI, Porter KB, O’Brien WF. Blunt versus Ansaloni 2001 {published data only}
sharp expansion of the uterine incision in low-segment Ansaloni L, Brundisini R, Morino G, Kiura A. Prospective,
transverse cesarean section. American Journal of Obstetrics randomized, comparative study of misgav ladach versus
and Gynecology 1994;171:1022–5. traditional cesarean section at Nazareth Hospital, Kenya.
World Journal of Surgery 2001;25(9):1164–72.
Sekhavat 2010 {published data only}
Sekhavat L, Firouzabadi RD, Mojiri P. Effect of expansion Baxter 2008 {published data only}
technique of uterine incision on maternal blood loss in Baxter JK. Comparison of tissue retractors during cesarean
cesarean section. Archives of Gynecology and Obstetrics 2010; delivery in obese women. http://clinicaltrials.gov/ct2/show/
282:475–9. NCT00358592 (accessed 20 February 2008).
Sood 2005 {published data only} Behrens 1997 {published data only}
Sood AK. Single versus double layer closure of low transverse Behrens D, Zimmerman S, Stoz F, Holzgreve W.
uterine incision and caesarean section. Journal of Obstetrics Conventional versus cohen-stark: a randomised comparison
and Gynaecology of India 2005;55(3):231–6. of the two techniques for cesarean section. 20th Congress of
the Swiss Society of Gynecology and Obstetrics; 1997 June;
Studzinski 2002 {published data only} Lugano, Switzerland. 1997:14.
Studzinski Z. The Misgav-Ladach method for cesarean
Buhimschi 2006 {published data only}
section compared to the Pfannenstiel technique [Ciecie
Buhimschi CS, Buhimschi IA, Zhao G, Funai EF, Peltecu
cesarskie sposobem Misgav–Ladach w porownaniu z
G, Saade GR, et al. Structural and biomedical properties of
technika Pfannenstiela]. Ginekologia Polska 2002;73(8):
the lower uterine segment above and below the reflection
672–6.
of the urinary bladder at cesarean section (CS). American
Villeneuve 1990 {published data only} Journal of Obstetrics and Gynecology 2006;195(6 Suppl 1):
Villeneuve MG, Khalife S, Marcoux S, Blanchet P. Surgical S89.
staples in cesarean section: a randomized controlled trial. Dargent 1990 {published data only}
American Journal of Obstetrics and Gynecology 1990;163: Dargent D, Audra P, Noblot G. Utilisation of the Poly CS57
1641–6. clip for Caesarean section. A randomised trial. Journal de
Von Rechenberg 1990 {published data only} Gynecologie, Obstetrique et Biologie de la Reproduction 1990;
Von Rechenberg KN. Use of a stapler for hysterotomy 18:961–2.
in Cesarean section [Die Anwendung eines Decavalas 1997 {published data only}
Klammernahtinstrumentes fur die Hysterotomie bei Decavalas G, Papadopoulos V, Tzingounis V. A prospective
der Sectio Caesarea]. Zeitschrift fur Geburtshilfe und comparison of surgical procedures in cesarean section. Acta
Perinatologie 1990;194:85–9. Obstetricia et Gynecologica Scandinavica 1997;76(167):13.
Wallin 1999 {published data only} Doganay 2010 {published data only}
∗
Wallin G, Fall O. Modified Joel-Cohen technique Doganay M, Tonguc EA, Var T. Effects of method of
for caesarean delivery. British Journal of Obstetrics and uterine repair on surgical outcome of cesarean delivery.
Gynaecology 1999;106(3):221–6. International Journal of Gynecology & Obstetrics 2010;111
Wallin G, Fall O. Modified Joel-Cohen technique for (2):175–8.
caesarean section. A prospective randomised study. Acta Falls 1958 {published data only}
Obstetricia et Gynecologica Scandinavica Supplement 1997; Falls F. Recent advances in obstetric and gynecologic
76(167:2):24. surgery. Journal of the American Medical Association 1958;
166:1409–12.
Xavier 2005 {published data only}
Ayres-de-Campos D, Patricio B. Modifications to the Gaucherand 2001 {published data only}
Misgav Ladach technique for cesarean section. Acta Gaucherand P, Bessai K, Sergeant P, Rudigoz RC. Towards
Obstetricia Gynecologica Scandinavica 2000;79:326–7. simplified cesarean section? [Vers une simplification de
∗
Xavier P, Ayres-De-Campos D, Reynolds A, Guimaraes l’operation cesarienne?]. Journal de Gynecologie, Obstetrique
M, Costa-Santos C, Patricio B. The modified Misgav- et Biologie de la Reproduction 2001;30(4):348–52.
Ladach versus the Pfannensteil-Kerr technique for cesarean Gedikbasi 2011 {published data only}
section: a randomized trial. Acta Obstetricia et Gynecologica Gedikbasi A, Akyol A, Ulker V, Yildirim D, Arslan O,
Scandinavica 2005;84(9):878–82. Karaman E, et al. Cesarean techniques in cases with one
previous cesarean delivery: comparison of modified Misgav- caesarean section on repeat caesarean delivery. European
Ladach and Pfannenstiel - Kerr. Archives of Gynecology and Journal of Obstetrics & Gynecology and Reproductive Biology
Obstetrics 2011;283(4):711–6. 2011;159(2):300–4.
Ghezzi 2001 {published data only} Moroz 2008 {published data only}
Ghezzi F, Franchi M, Raio L, Naro Di E, Balestreri D, Moroz L, Bowers G, Hayes EJ, O’Brien J, Carroll T, Baxter
Miglierina M, et al. Pfannestiel or joel-cohen incision at JK. Self-retained compared with traditional retractors for
cesarean delivery: a randomized clinical trial [abstract]. cesarean delivery in obese women, a randomized controlled
American Journal of Obstetrics and Gynecology 2001;184(1): trial. Obstetrics & Gynecology 2008;111(4 Suppl):101S.
S166.
Naki 2011 {published data only}
Giacalone 2002 {published data only} Naki MM, Api O, Celik H, Kars B, Yasar E, Unal O.
Giacalone PL, Daures JP, Vignal J, Herisson C, Hedon Comparative study of Misgav-Ladach and Pfannenstiel-
B, Laffargue F. Pfannenstiel versus maylard incision for Kerr cesarean techniques: a randomized controlled trial.
cesarean delivery: a randomized controlled trial. Obstetrics Journal of Maternal-Fetal and Neonatal Medicine 2011;24
& Gynecology 2002;99:745–50. (2):239–44.
Hameed 2004 {published data only} Ohel 1996 {published data only}
Hameed N, Ali MA. Maternal blood loss by expansion of Ohel G, Younis JS, Lang N, Levit A. Double-layer closure of
uterine incision at caesarean section--a comparison between uterine incision with visceral and parietal peritoneal closure:
sharp and blunt techniques. Journal of Ayub Medical College are they obligatory steps of routine cesarean sections?.
Abbottabad 2004;16(3):47–50. Journal of Maternal-Fetal Medicine 1996;5(6):366–9.
Heidenreich 1995 {published data only}
Ozbay 2011 {published data only}
Heidenreich W, Bruggenjurgen K. Modified Sarafoff suture
Ozbay K. Exteriorized versus in-situ repair of the uterine
for single layer closure of uterotomy in cesarean section. A
incision at cesarean delivery: a randomized controlled trial.
prospective study. Zentralblatt fur Gynakologie 1995;117:
Clinical and Experimental Obstetrics and Gynecology 2011;
40–4.
38(2):155–8.
Heimann 2000 {published data only}
Heimann J, Hitschold T, Muller K, Berle P. Randomized Redlich 2001 {published data only}
trial of the modified misgav-ladach and the conventional Redlich A, Koppe I. The ”gentle caesarean section“ - an
pfannensteil techniques for cesarean section. Geburtshilfe alternative to the classical way of section. A prospective
und Frauenheilkunde 2000;60:242–50. comparison between the classical technique and the method
of misgav ladach [”Die sanfte Sectio“ – Eine Alternative
Hohlagschwandtner {published data only}
zur klassischen Sectiotechnik – Prospektiver Vergleich der
Hohlagschwandtner M, Chalubinski K, Nather A,
klassischen Technik mit der Misgav–Ladach–Methode].
Husslein P, Joura EA. Sonographic findings after cesarean
Zentralblatt fur Gynakologie 2001;123(11):638–43.
section without formation of a bladder flap [Sectio
caesarea ohne Blasenpraparation: Eine sonographische Van Dongen 1989 {published data only}
Nachuntersuchung.]. Geburtshilfe und Frauenheilkunde Van Dongen P, Nijhuis J, Jongsma H. Reduced blood
2002;62(2):163–6. loss during caesarean section due to a controlled stapling
∗
Hohlagschwandtner M, Ruecklinger E, Husslein P, Joura technique. Acta Obstetricia et Gynecologica Scandinavica
E. Is the formation of a bladder flap at cesarean necessary? 1997;76(167):20.
A randomized trial. Obstetrics & Gynecology 2001;98: Van Dongen PWJ, Nijhuis JG, Jongsma HW. Reduced
1089–92. blood loss during Caesarean section due to a controlled
Hoskins 1991 {published data only} stapling technique. European Journal of Obstetrics &
Hoskins IA, Ordorica SA, Frieden FJ, Young BK. Gynecology and Reproductive Biology 1989;32:95–102.
Performance of Cesarean section using absorbable staples.
References to studies awaiting assessment
Surgery, Gynecology and Obstetrics 1991;172:108–12.
Kiefer 2008 {published data only} Belci 2005 {published data only}
Kiefer DG. A multicenter, randomized, controlled trial of Belci D, Kos M, Zoricic D, Kuharic L, Slivar A, Begic-
Seprafilm® adhesion barrier to reduce adhesion formation Razem E, et al. Misgav Ladach surgical technique
following cesarean delivery. http://clinicaltrials.gov/ct2/ of cesarean section: our experience at Pula General
show/NCT00565643 (accessed 20 February 2008). Hospital [Carski rez po misgav ladachu: Iskustva u Puli].
Lodh 2002 {published data only} Gynaecologia et Perinatologia 2005;14(4):171–8.
Lodh E, Bhattacharjee P. Single layer closure of caesarean Borowski 2007 {published data only}
section - a comparative study. Journal of Obstetrics and Borowski K, Andrews J, Hocking M, Hansen W, Fleener D,
Gynaecology of India 2002;52(2):35–6. Syrop C. Ultrasonographic detection of cesarean scar defects
Malvasi 2011 {published data only} in a trial of single versus double layer closure. American
Malvasi A, Tinelli A, Guido M, Cavallotti C, Dell’edera D, Journal of Obstetrics and Gynecology 2007;197(6 Suppl 1):
Zizza A, et al. Effect of avoiding bladder flap formation in S62, Abstract no: 183.
Hagen 1999 {published data only} Deeks 2001
Hagen A, Schmid O, Runkel S, Weitzel H, Hopp H. A Deeks JJ, Altman DG, Bradburn MJ. Statistical methods
randomized trial of two surgical techniques for cesarean for examining heterogeneity and combining results from
section. European Journal Obstetrics & Gynecology and several studies in meta-analysis. In: Eggar M, Davey Smith
Reproductive Biology 1999;86:S81. G, Altman DG (eds) editor(s). Systematic Reviews in Health
Mazhar 2004 {published data only} Care: Meta-analysis in Context. London: BMJ Publishing
Mazhar SB, Mahsood S. Single versus double layer uterine Group, 2001.
closure during cesarean section: a randomised trial. 30th Higgins 2002
British Congress of Obstetrics and Gynaecology; 2004 July Higgins JPT, Thompson SG. Quantifying heterogeneity in
7-9; Glasgow, UK. 2004:63. a meta-analysis. Statistics in Medicine 2002;21:1539–58.
Mukhopadhyay 2000 {published data only} Higgins 2011
Mukhopadhyay B. Single layer - vs - two layer closure of Higgins JPT, Green S, editors. Cochrane Handbook for
uterus during caesarean section - an institutional experience Systematic Reviews of Interventions Version 5.1.0 [updated
[abstract]. XVI FIGO World Congress of Obstetrics & March 2011]. The Cochrane Collaboration, 2011.
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USA. 2000:43.
Pandey 2006 {published data only} Hofmeyr 2008
Pandey R, Kant A. Single layer closure of uterine incision Hofmeyr GJ, Mathai M, Shah AN, Novikova N.
without closure of visceral and parietal peritonium vs. Techniques for caesarean section. Cochrane Database
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parietal peritoneal closure - a comparative study. 49th 14651858.CD004662.pub2]
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January 6-9; Cochin, Kerala State, India. 2006:102. The Nordic Cochrane Centre, The Cochrane Collaboration.
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Wojdemann K, Bennich G. Long term follow-up from a The Nordic Cochrane Centre, The Cochrane Collaboration,
randomized trial comparing one- and two- layer closure 2012.
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and Gynecology 2010;36(Suppl 1):141. Tahilramaney MP, Boucher M, Eglinton GS, Beall M,
Phelan JP. Previous cesarean section and trial of labor.
References to ongoing studies
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Medicine 1984;29(1):17–21.
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References to other published versions of this review
and misgav-ladach techniques in cesarean section. IRCT
Iranian Registry of Clinical Trials (www.irct.ir) (accessed 6
December 2010) (accessed 6 December 2010). Dodd 2008
Dodd JM, Anderson ER, Gates S. Surgical techniques for
Additional references uterine incision and uterine closure at the time of caesarean
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rupture. American Journal of Obstetrics and Gynecology Wilkinson 2006
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Obstetrics & Gynecology 1997;89:16–8. ∗
Indicates the major publication for the study
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Batioglu 1998
Methods Method of randomisation: not stated.

Allocation concealment: not stated.
Blinded outcome assessment: not stated.
Completeness of follow-up: outcome data available for 118 women
Participants 118 women undergoing caesarean section. Women with preterm, prelabour ruptured
membranes, chorioamnionitis, or gestational age less than 36 weeks were excluded
Interventions Single layer uterine closure versus double layer uterine closure
Outcomes Operating time, duration of hospital stay, postoperative complications, change in haema-
tocrit values
Notes Trial conducted in Turkey.
Risk of bias Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection Unclear risk Not stated.

bias)
Allocation concealment (selection bias) Unclear risk Not stated.
Incomplete outcome data (attrition bias) Low risk Outcome data available for 118 women.
All outcomes
Selective reporting (reporting bias) Low risk Appears to be free of selective reporting.
Other bias Low risk Appears to be free of other bias.
Blinding of participants and personnel Unclear risk Not stated.

(performance bias)
All outcomes
Blinding of outcome assessment (detection Unclear risk Not stated.

bias)
All outcomes
Bjorklund 2000
Methods Method of randomisation: computer-generated randomisation sequence.

Allocation concealment: sequential sealed envelopes.
Blinded outcome assessment: no.
Completeness of follow-up: outcome data available for 339 women (1 women excluded
after randomisation)
Participants 340 women undergoing emergency or elective caesarean section. Women with prior
caesarean section, prior abdominal surgery, known anaemia, diabetes mellitus, bleeding
disorder, intrapartum febrile illness, uterine rupture excluded
Interventions Single layer uterine closure (Misgav Ladach procedure) versus double layer uterine closure
Outcomes Operating time, blood loss, blood loss greater than 500 mL, Apgar scores, antibiotic use,
postpartum complications, duration hospitalisation
Notes Trial conducted Dar es Salaam, Tanzania.
Random sequence generation (selection Low risk Computer-generated randomisation se-

bias) quence.
Allocation concealment (selection bias) Low risk Sequential sealed envelopes.
Incomplete outcome data (attrition bias) Low risk Outcome data available for 339 women (1
All outcomes women excluded after randomisation)
Blinding of participants and personnel High risk No blinding of participants and personnel.
(performance bias)
All outcomes
Blinding of outcome assessment (detection High risk No blinding of outcome assessment.

bias)
All outcomes
CAESAR 2010
Methods Method of randomisation: computer-generated randomisation sequence with minimi-

sation algorithm.
Allocation concealment: telephone randomisation service.
Blinded outcome assessment: yes.
Completeness of follow-up: outcome data available for 2979 women (306 women lost
to 6 week follow-up)
Participants 3033 women undergoing primary lower segment caesarean section
Interventions 1. Single versus double layer closure of uterus.

2. Closure versus non-closure of pelvic peritoneum.
3. Liberal versus restricted use of sub-rectus sheath drain.
Outcomes Infectious morbidity (including wound infection requiring antibiotics, endometritis and
antibiotic use for febrile episode prior to hospital discharge); fever; operating time;
need for blood transfusion; severe maternal morbidity; hospital readmission; operative
procedures on wound
Notes Trial conducted in 45 sites in United Kingdom and 2 sites in Italy

Primary outcome modified after recruitment of 600 women.
Trial stopped prior to reaching estimated sample size of 3500 women

bias) quence with minimisation algorithm
Allocation concealment (selection bias) Low risk Telephone randomisation service.
Incomplete outcome data (attrition bias) Low risk Outcome data available for 2979 women
All outcomes (306 women lost to 6 week follow-up)
Selective reporting (reporting bias) Low risk Not apparent.
Other bias High risk Primary outcome modified after recruit-

ment of 600 women.
Trial stopped prior to reaching estimated
sample size of 3500 women

(performance bias)
All outcomes
Blinding of outcome assessment (detection Low risk Blinded outcome assessment.

bias)
All outcomes
Ceci 2012
Methods Randomised trial.
Participants 60 women who were primiparous at term with a singleton pregnancy, delivered by elective
LSCS
Interventions Uterine closure with continuous locked single layer suture versus interrupted single layer
suture
Outcomes Ultrasound measures and hysteroscopic assessment of the uterine wall defect if present
at 24 months. No clinical outcomes reported
Notes
Random sequence generation (selection Low risk Random number sequence.

bias)
Allocation concealment (selection bias) Unclear risk Not specified.
Incomplete outcome data (attrition bias) Low risk Primary outcome data on over 80% of women at 6 months.
All outcomes
Selective reporting (reporting bias) Unclear risk Unclear.
Other bias Unclear risk Unclear.
Blinding of participants and personnel High risk Not blinded as per the authors.
(performance bias)
All outcomes
Blinding of outcome assessment (detection Low risk Ultrasound and hysteroscopy operators were blinded to the su-
bias) ture technique
All outcomes
Chitra 2004
Methods Method of randomisation: stated to be ”randomly allocated by random numbers“.

Participants 200 women undergoing primary caesarean section. Women with placenta praevia or
abruption, prior caesarean section, obstructed labour, prior abdominal surgery, multiple
pregnancy or ruptured uterus were excluded
Interventions Single versus double layer closure of uterus.
Chitra 2004 (Continued)
Outcomes Mean blood loss; operating time.
Notes Trial conducted in India.
Random sequence generation (selection Unclear risk Stated to be ”randomly allocated by ran-
bias) dom numbers“.
Incomplete outcome data (attrition bias) Unclear risk Not stated.

All outcomes

(performance bias)
All outcomes

bias)
All outcomes
CORONIS 2013
Methods Method of randomisation: computer-generated random number list.

Allocation concealment: secure web-based system.
Blinded outcome assessment: investigators were not blinded? ” all investigators, surgeons
and participants were unmasked to treatment allocation“.
Completeness of follow-up: 6-week data available for 98% of women
Participants Pregnant women who were to undergo delivery by LSCS through a transverse abdominal
incision, irrespective of fever in labour, gestational age, or multiple pregnancies. Not
eligible if there was a clear indication for a particular surgical technique or material to
be used that prevented any of the allocated interventions being used, if they had more
than one previous caesarean section or if they had already been recruited into the trial
Interventions 5 pairs.
Outcomes Primary was a maternal composite of death and severe morbidity, plus a range of maternal
and infant outcomes as secondary outcomes
Notes
CORONIS 2013 (Continued)
Random sequence generation (selection Low risk Central server, computer-generated ran-
bias) domisation list.
Allocation concealment (selection bias) Low risk Central secure web-based system.
Incomplete outcome data (attrition bias) Low risk 98% outcome data at 6 weeks (primary
All outcomes outcome).
Selective reporting (reporting bias) Low risk
Other bias Low risk No apparent sources of other bias.
Blinding of participants and personnel High risk Participants and clinicians and investiga-
(performance bias) tors were not blinded
All outcomes
Blinding of outcome assessment (detection Unclear risk Unclear who assessed the primary outcome
bias) ? investigators or other
All outcomes
Cromi 2008
Methods Method of randomisation: computer-generated random number list.

Participants 811 women undergoing caesarean section at greater than 30 weeks’ gestation
Interventions Transverse versus cephalad-caudad direction of blunt extension of uterine incision
Outcomes Mean blood loss; need for blood transfusion; operating time.
Notes Trial conducted in Italy.
Random sequence generation (selection Low risk Computer-generated random number list.
bias)
Cromi 2008 (Continued)
Incomplete outcome data (attrition bias) Low risk Outcomes available for 811 women.
All outcomes
Selective reporting (reporting bias) Low risk Appears free of selective reporting.
Other bias Low risk Appears free of other bias.

(performance bias)
All outcomes

bias)
All outcomes
Dani 1998
Methods Method of randomisation: stated that participants were ’randomised’.

Completeness of follow-up: outcomes reported for 154 infants of women undergoing
caesarean section
Participants 154 infants of women undergoing elective caesarean section after 36 weeks’ gestation
Outcomes Neonatal respiratory depression, birth asphyxia, cord gases.
Notes Trial conducted in Italy; no prespecified outcomes reported.
Random sequence generation (selection Unclear risk Stated to be randomised.

bias)
Incomplete outcome data (attrition bias) Unclear risk Outcomes for 154 infants available.
All outcomes
Selective reporting (reporting bias) Unclear risk Unable to assess.
Other bias Unclear risk Unable to assess.
Dani 1998 (Continued)

(performance bias)
All outcomes
Blinding of outcome assessment (detection Low risk Blinded outcome assessment: yes.
bias)
All outcomes
Darj 1999
Methods Method of randomisation: not stated (participants stated to be ’randomly allocated’).

Completeness of follow-up: outcome data available for 50 women undergoing caesarean
section
Participants 50 women undergoing elective caesarean section at term.
Outcomes Duration surgery, blood loss, doses of analgesics required, duration hospitalisation
Notes Trial conducted in Sweden.
Random sequence generation (selection Unclear risk Stated to be randomly allocated.

bias)
Allocation concealment (selection bias) Low risk Sequential sealed opaque envelopes.
Incomplete outcome data (attrition bias) Low risk Outcome data available for 50 women un-
All outcomes dergoing caesarean section

(performance bias)
All outcomes

bias)
All outcomes
Ferrari 2001

Completeness of follow-up: outcome data available for 158 women randomised
Participants 158 women undergoing caesarean section at greater than 30 weeks’ gestation, with no
prior caesarean birth
Outcomes Duration of operation, blood loss, antibiotic use, urinary tract infection, endometritis,
febrile morbidity, postoperative pain score and need for analgesia
Notes Trial conducted in Italy.

bias)
Allocation concealment (selection bias) Low risk Sequential sealed opaque envelopes.
Incomplete outcome data (attrition bias) Low risk Outcome data available for 158 women
All outcomes randomised.

(performance bias)
All outcomes

bias)
All outcomes
Gutierrez 2008
Methods Method of randomisation: patients were divided in 2 random groups.

Participants 48 Primigravid women undergoing primary lower segment caesarean section between
37 and 42 weeks’ gestation
Gutierrez 2008 (Continued)
Outcomes Mean blood loss; mean operating time.
Notes Trial conducted in Mexico.
Random sequence generation (selection Unclear risk Stated that patients were divided in 2 ran-
bias) dom groups.
All outcomes

(performance bias)
All outcomes

bias)
All outcomes
Hamar 2007

Completeness of follow-up: outcome data available for 30 women randomised
Participants 30 women undergoing primary caesarean section. Exclusions: multiple gestations, ab-
normal fetal heart rate tracing, prior uterine surgery, hydramnios, uterine malformation,
diabetes, connective tissue disorder, non-English speaking
Outcomes Chorioamnionitis, endometritis, duration surgery, blood loss, ultrasound assessment of

wound
Notes Trial conducted in USA.
Hamar 2007 (Continued)

bias)
All outcomes

(performance bias)
All outcomes

bias)
All outcomes
Hauth 1992
Methods Method of randomisation: computer-generated random-number table.

Completeness of follow-up: 85 women excluded after randomisation (8.6%)
Participants 991 women undergoing caesarean section. Women where vertical or T-incision required,
unable to perform allocated closure, or incomplete data available were excluded
Outcomes Operative time, haemostasis, blood loss, infection, need for haemostatic sutures, en-
dometritis, need for blood transfusion
Notes Trial conducted USA. Follow-up of 164 women in subsequent pregnancy reported
(Chapman)
Hauth 1992 (Continued)
Random sequence generation (selection Low risk Computer-generated random number ta-
bias) ble.
Incomplete outcome data (attrition bias) Low risk 85 women excluded after randomisation.
All outcomes
Blinding of participants and personnel High risk

(performance bias)
All outcomes
Blinding of outcome assessment (detection High risk

bias)
All outcomes
Hidar 2007

Allocation concealment: sealed opaque envelopes.
Participants 300 Women undergoing caesarean section after 36 weeks’ gestation (either elective or
emergency procedure) with a singleton fetus. Women less than 20 years of age, coagu-
lopathy or placenta praevia were excluded
Interventions Sharp versus blunt extension of the uterine incision.
Outcomes Endometritis.
Notes Trial conducted in Tunisia.

bias) quence.
Allocation concealment (selection bias) Low risk Sealed opaque envelopes.
All outcomes
Hidar 2007 (Continued)

(performance bias)
All outcomes

bias)
All outcomes
Lal 1988
Methods Method of randomisation: ”allocated randomly“ (unclear).

Allocation concealment: not stated (unclear).
Completeness of follow-up: outcome data available on 100 women
Participants 100 women undergoing caesarean section for ”variety of indications“
Outcomes ”Minor“ and ”major“ anomalies of the uterus detected 3 months postpartum by hys-
terogram
Notes Trial conducted India.
Random sequence generation (selection Unclear risk Stated to be randomly allocated.

bias)
Incomplete outcome data (attrition bias) Unclear risk Outcome data available for 100 women.
All outcomes

(performance bias)
All outcomes
Lal 1988 (Continued)

bias)
All outcomes
Magann 2002

section
Participants 945 women undergoing caesarean section with low transverse uterine incision
Interventions Blunt dissection of the uterine incision versus sharp dissection of the uterine incision
Outcomes Blood loss, extension of the incision, need for transfusion, endometritis
Random sequence generation (selection Low risk Computer- generated random number ta-
bias) ble.
All outcomes

(performance bias)
All outcomes

bias)
All outcomes
Moreira 2002
Methods Method of randomisation: not described.

Allocation concealment: not described.
Blinded outcome assessment: not indicated.
section
Participants 400 women undergoing caesarean section.
Outcomes Endometritis.
Notes Trial conducted in Senegal.

bias)
All outcomes
Other bias Low risk Appears to be free of selective reporting.

(performance bias)
All outcomes

bias)
All outcomes
Poonam 2006
Methods Method of randomisation: stated to be randomised.

Participants 400 Women undergoing primary lower segment caesarean section at greater than 37
weeks’ gestation
Poonam 2006 (Continued)
Interventions 1. Blunt versus sharp dissection uterine incision.

2. Single versus double layer closure of uterus.
Outcomes Infectious morbidity; blood loss; need for blood transfusion; maternal death or serious
morbidity
Notes Trial conducted in Nepal.

bias)
All outcomes

(performance bias)
All outcomes

bias)
All outcomes
Rodriguez 1994

section
Participants 296 women undergoing caesarean section. Women excluded if there was insufficient
time to provide consent or due to time restraints due to an emergency procedure
Interventions Blunt dissection of the uterine incision versus sharp dissection of the uterine incision
Outcomes Change in haemoglobin, delivery time, extension of the incision, damage to blood vessels,
endometritis
Rodriguez 1994 (Continued)

bias)
All outcomes

(performance bias)
All outcomes

bias)
All outcomes
Sekhavat 2010

Participants 200 primiparous women undergoing caesarean section at term. Women with multiple
pregnancy, major medical or surgical conditions, anaemia, thromboembolic disease,
polyhydramnios or requiring emergency caesarean section were excluded
Outcomes Operating time; blood loss; need for blood transfusion.
Notes Trial conducted in Iran.
Sekhavat 2010 (Continued)

bias) quence.
All outcomes
Blinding of participants and personnel Low risk Participants blinded.

(performance bias)
All outcomes

bias)
All outcomes
Sood 2005

Outcomes Data presented not able to be used.
Notes Trial conducted in India.

bias) quence.
Incomplete outcome data (attrition bias) Low risk Outcomes for 208 women.
All outcomes
Sood 2005 (Continued)

(performance bias)
All outcomes
Blinding of outcome assessment (detection Low risk Outcome assessor blinded.

bias)
All outcomes
Studzinski 2002

Outcomes Infectious morbidity operating time; blood loss.
Notes Trial conducted in Poland.

bias)
Incomplete outcome data (attrition bias) Low risk Outcome data for 110 women.
All outcomes

(performance bias)
All outcomes
Studzinski 2002 (Continued)

bias)
All outcomes
Villeneuve 1990
Methods Method of randomisation: random-number table.

section
Participants 200 women undergoing lower uterine segment caesarean section
Interventions Auto suture device versus standard hysterotomy.
Outcomes Operating time, blood loss, change in haemoglobin, febrile morbidity, postoperative
complications, length of hospitalisation
Notes Trial conducted in Canada.
Random sequence generation (selection Low risk Random number table.

bias)
All outcomes

(performance bias)
All outcomes

bias)
All outcomes
Von Rechenberg 1990
Methods Method of randomisation: ”randomised“ - no further information provided.

Allocation concealment: no information provided.
Blinded outcome assessment: no information provided.
Completeness of follow-up: no exclusions reported.
Participants 100 women undergoing caesarean section. Exclusions: clotting dysfunction, multiple
pregnancy, delivery less than 32 weeks
Interventions Auto suture device versus conventional incision (no further information provided)
Outcomes Blood loss, transfusion, wound haematoma (US assessed), febrile morbidity, antibiotic
use, endometritis, duration of hospital stay
Notes Trial conducted in Switzerland.

bias)
Incomplete outcome data (attrition bias) Low risk Data available for 100 women.
All outcomes

(performance bias)
All outcomes

bias)
All outcomes
Wallin 1999

section
Wallin 1999 (Continued)
Participants 72 women undergoing elective caesarean section in the absence of a history of prior
abdominal surgery
Outcomes Median operating time, blood loss, length of hospitalisation
Notes Trial conducted in Sweden.
bias) ble.
All outcomes

(performance bias)
All outcomes
Blinding of outcome assessment (detection Low risk Outcome assessor blinded.

bias)
All outcomes
Xavier 2005

Allocation concealment: unclear.
section
Participants 162 women undergoing caesarean section by 1 of 3 operating surgeons
Outcomes Wound infection, febrile morbidity requiring antibiotics.
Xavier 2005 (Continued)
Notes Trial conducted in Portugal.
bias) ble.
Incomplete outcome data (attrition bias) Low risk Outcomes available for 72 of 162 women
All outcomes randomised.
Other bias High risk Data available for 44.4% of women ran-
domised.

(performance bias)
All outcomes
Blinding of outcome assessment (detection Low risk Blinding of outcomes assessment.

bias)
All outcomes
Yasmin 2011
Methods A randomised double blind trial.
Participants Singleton, term pregnancies, scheduled for repeat elective caesarean section
Interventions Group A - 1 layer closure, Group B - 2 layer closure, Group C - modified 2 layer closure
Outcomes Blood loss, operating time and ultrasound findings at 6 weeks and at time of next
caesarean section
Notes
Random sequence generation (selection High risk Random allocation made using cards, patient picked
bias) cards from a box
Allocation concealment (selection bias) High risk Allocation not concealed after generated, see above.
Yasmin 2011 (Continued)
Incomplete outcome data (attrition bias) High risk Only approximately 50% of patients followed at
All outcomes time of next caesarean section which was one of the
main aims of the study
Selective reporting (reporting bias) Low risk None apparent.
Other bias Low risk None apparent.
Blinding of participants and personnel Unclear risk States ”double blind trial“, but not entirely clear,
(performance bias) ”The group allocation was revealed to the surgeon
All outcomes during the surgery just before the uterine incision
closure,“ not clear if or participants were blinded
Blinding of outcome assessment (detection Unclear risk Some blinding of outcome assessors. Postoperative
bias) evaluation of uterine incision, ”Measurements were
All outcomes done by one of the investigators who were blinded
to the allocation group for type of closure“
LSCS: lower segment caesarean section

US: ultrasound
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Ansaloni 2001 Study used quasi-randomised allocation to the intervention based on alternate allocation
Baxter 2008 The comparison did not involve techniques on the uterus and was outside the scope of this review
Behrens 1997 Study used quasi-randomised allocation to the intervention based on alternate allocation
Buhimschi 2006 The comparison did not involve techniques on the uterus and was outside the scope of this review
Dargent 1990 Study used quasi-randomised allocation based on mother’s month of birth
Decavalas 1997 The comparison did not involve techniques on the uterus and was outside the scope of this review
Doganay 2010 The comparison did not involve techniques on the uterus and was outside the scope of this review
Falls 1958 Study used quasi-randomised allocation to the intervention based on alternate allocation
Gaucherand 2001 Study used quasi-randomised allocation to the intervention based on odd/even date of surgery
(Continued)
Gedikbasi 2011 The comparison did not involve techniques on the uterus and was outside the scope of this review
Ghezzi 2001 The comparison did not involve techniques on the uterus and was outside the scope of this review
Giacalone 2002 Excluded as the comparison involved Maylard versus Pfannensteil procedure for caesarean section. The Maylard
procedure describes entry into the abdominal cavity, prior to entry of the uterine cavity. The comparison did
not involve techniques on the uterus and was outside the scope of this review
Hameed 2004 Study used a convenient sampling method to allocate treatment groups
Heidenreich 1995 Study used quasi-randomised allocation to the intervention based on alternate allocation
Heimann 2000 Analysis was not based on intention-to-treat principles and it was not possible to restore participants to their
randomised intervention from the results presented
Hohlagschwandtner Excluded as the comparison involved bladder dissection prior to uterine entry versus no bladder dissection.
The comparison did not involve techniques on the uterus and was outside the scope of this review
Hoskins 1991 Study used quasi-randomised allocation to the intervention based on odd or even allocation using medical
record number
Kiefer 2008 The comparison did not involve techniques on the uterus and was outside the scope of this review
Lodh 2002 Study utilised a case-control design and was not randomised.
Malvasi 2011 The comparison did not involve techniques on the uterus and was outside the scope of this review
Moroz 2008 The comparison did not involve techniques on the uterus and was outside the scope of this review
Naki 2011 The comparison did not involve techniques on the uterus and was outside the scope of this review
Ohel 1996 Study used quasi-randomised allocation to the intervention based on odd or even allocation using medical
record number
Ozbay 2011 The comparison did not involve techniques on the uterus and was outside the scope of this review
Redlich 2001 Study used quasi-randomised allocation to the intervention based on patient surname
Van Dongen 1989 Study used quasi-randomised allocation to the intervention based on alternate allocation
Characteristics of studies awaiting assessment [ordered by study ID]
Belci 2005
Methods
Participants
Interventions
Outcomes
Notes Polish - needs translation.
Borowski 2007
Methods
Participants
Interventions
Outcomes
Notes In abstract form only, with insufficient information available to allow assessment for inclusion in this review
Hagen 1999
Methods
Participants
Interventions
Outcomes
Mazhar 2004
Methods
Participants
Interventions
Outcomes
Mukhopadhyay 2000
Methods
Participants
Interventions
Outcomes
Pandey 2006
Methods
Participants
Interventions
Outcomes
Wojdemann 2010
Methods
Participants
Interventions
Outcomes
Characteristics of ongoing studies [ordered by study ID]
Farajzadeh 2010
Trial name or title The comparison of outcomes of traditional and misgav-ladach techniques in cesarean section
Methods
Participants
Interventions
Outcomes
Farajzadeh 2010 (Continued)
Starting date
Contact information IRCT Iranian Registry of Clinical Trials (www.irct.ir) (accessed 6 December 2010)
Notes
DATA AND ANALYSES
Comparison 1. Methods of performing the uterine incision: auto stapler versus conventional
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Febrile morbidity 2 300 Risk Ratio (M-H, Fixed, 95% CI) 0.92 [0.38, 2.20]
2 Mean blood loss 1 200 Mean Difference (IV, Fixed, 95% CI) -87.0 [-175.09, 1.
09]
3 Duration of surgery 1 197 Mean Difference (IV, Fixed, 95% CI) 3.30 [-0.02, 6.62]
4 Duration of postnatal stay 1 200 Mean Difference (IV, Fixed, 95% CI) 0.0 [-0.28, 0.28]
5 Wound complications 1 100 Risk Ratio (M-H, Fixed, 95% CI) 1.5 [0.67, 3.35]
6 Need for blood transfusion 1 100 Risk Ratio (M-H, Fixed, 95% CI) 1.5 [0.26, 8.60]
7 Endometritis 1 100 Risk Ratio (M-H, Fixed, 95% CI) 0.2 [0.02, 1.65]
Comparison 2. Methods of performing the uterine incision: blunt versus sharp dissection
No. of No. of
1 Postoperative febrile morbidity 4 1941 Risk Ratio (M-H, Fixed, 95% CI) 0.86 [0.70, 1.05]
(including endometritis)
2 Mean blood loss 2 1145 Mean Difference (IV, Random, 95% CI) -53.00 [-79.48, -30.
52]
4 Maternal death or serious 1 400 Risk Ratio (M-H, Fixed, 95% CI) 3.0 [0.12, 73.20]
morbidity
5 Duration of surgery 1 200 Mean Difference (IV, Fixed, 95% CI) -2.80 [-5.84, 0.24]
Comparison 3. Methods of performing the uterine incision: transverse versus cephalad-caudad blunt extension
No. of No. of
1 Mean blood loss 1 811 Mean Difference (IV, Fixed, 95% CI) 42.0 [1.31, 82.69]
3 Duration of surgery 1 811 Mean Difference (IV, Fixed, 95% CI) -1.50 [-3.13, 0.13]
Comparison 4. Single layer uterine closure versus double layer uterine closure
No. of No. of
2 Blood loss greater than 500 mL 1 339 Risk Ratio (M-H, Fixed, 95% CI) 0.70 [0.42, 1.18]
3 Need for blood transfusion 4 13571 Risk Ratio (M-H, Random, 95% CI) 0.86 [0.63, 1.17]
4 Wound infection 5 13389 Risk Ratio (M-H, Fixed, 95% CI) 0.99 [0.89, 1.10]
5 Operative procedure on wound 3 12604 Risk Ratio (M-H, Fixed, 95% CI) 0.80 [0.53, 1.21]
6 Postoperative anaemia 2 1245 Risk Ratio (M-H, Fixed, 95% CI) 1.05 [0.83, 1.32]
7 Complication of future 1 145 Risk Ratio (M-H, Fixed, 95% CI) 3.21 [0.13, 77.55]
pregnancy
8 Postoperative pain present 2 9444 Risk Ratio (M-H, Random, 95% CI) 0.88 [0.54, 1.42]
9 Complications post-op requiring 1 9286 Risk Ratio (M-H, Fixed, 95% CI) 0.85 [0.63, 1.16]
re-laparotomy
10 Length of hospital stay 1 158 Mean Difference (IV, Fixed, 95% CI) -0.10 [-0.52, 0.32]
11 Death or serious maternal 3 12665 Risk Ratio (M-H, Fixed, 95% CI) 1.04 [0.71, 1.54]
morbidity
12 Maternal readmission 1 9286 Risk Ratio (M-H, Fixed, 95% CI) 1.12 [0.70, 1.79]
Comparison 5. Techniques for closing the uterus: chromic catgut versus polygactin-910
No. of No. of
3 Wound infection 1 9544 Risk Ratio (M-H, Fixed, 95% CI) 0.99 [0.82, 1.19]
4 Operative procedure on wound 1 9544 Risk Ratio (M-H, Fixed, 95% CI) 0.64 [0.36, 1.13]
5 Postoperative pain present 1 9544 Risk Ratio (M-H, Fixed, 95% CI) 0.86 [0.70, 1.07]
6 Complications post-op requiring 1 9544 Risk Ratio (M-H, Fixed, 95% CI) 0.58 [0.37, 0.89]
re-laparotomy
7 Death or serious maternal 1 9544 Risk Ratio (M-H, Fixed, 95% CI) 0.68 [0.44, 1.06]
morbidity
8 Maternal readmission 1 9544 Risk Ratio (M-H, Fixed, 95% CI) 1.00 [0.58, 1.72]
Analysis 1.1. Comparison 1 Methods of performing the uterine incision: auto stapler versus conventional,
Outcome 1 Febrile morbidity.
Review: Surgical techniques for uterine incision and uterine closure at the time of caesarean section
Comparison: 1 Methods of performing the uterine incision: auto stapler versus conventional
Outcome: 1 Febrile morbidity
Study or subgroup Stapler Conventional Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Villeneuve 1990 4/98 6/102 59.5 % 0.69 [ 0.20, 2.38 ]
Von Rechenberg 1990 5/50 4/50 40.5 % 1.25 [ 0.36, 4.38 ]
Total (95% CI) 148 152 100.0 % 0.92 [ 0.38, 2.20 ]

Total events: 9 (Stapler), 10 (Conventional)
Heterogeneity: Chi2 = 0.43, df = 1 (P = 0.51); I2 =0.0%
Test for overall effect: Z = 0.19 (P = 0.85)
Test for subgroup differences: Not applicable
0.1 0.2 0.5 1 2 5 10

Favours stapler Favours conventional
Outcome 2 Mean blood loss.
Outcome: 2 Mean blood loss
Mean Mean
Study or subgroup Stapler Conventional Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI
Villeneuve 1990 98 492 (237.6) 102 579 (383.8) 100.0 % -87.00 [ -175.09, 1.09 ]
Total (95% CI) 98 102 100.0 % -87.00 [ -175.09, 1.09 ]

Heterogeneity: not applicable
-100 -50 0 50 100

Outcome 3 Duration of surgery.
Outcome: 3 Duration of surgery
Mean Mean
Villeneuve 1990 97 42.5 (11.8) 100 39.2 (12) 100.0 % 3.30 [ -0.02, 6.62 ]
Total (95% CI) 97 100 100.0 % 3.30 [ -0.02, 6.62 ]

-10 -5 0 5 10
Outcome 4 Duration of postnatal stay.
Outcome: 4 Duration of postnatal stay
Mean Mean
Villeneuve 1990 98 6.3 (0.99) 102 6.3 (1.01) 100.0 % 0.0 [ -0.28, 0.28 ]
Total (95% CI) 98 102 100.0 % 0.0 [ -0.28, 0.28 ]

-10 -5 0 5 10
Outcome 5 Wound complications.
Outcome: 5 Wound complications

Von Rechenberg 1990 12/50 8/50 100.0 % 1.50 [ 0.67, 3.35 ]
Total (95% CI) 50 50 100.0 % 1.50 [ 0.67, 3.35 ]

0.1 0.2 0.5 1 2 5 10

Outcome 6 Need for blood transfusion.
Outcome: 6 Need for blood transfusion

Von Rechenberg 1990 3/50 2/50 100.0 % 1.50 [ 0.26, 8.60 ]
Total (95% CI) 50 50 100.0 % 1.50 [ 0.26, 8.60 ]

0.1 0.2 0.5 1 2 5 10

Outcome 7 Endometritis.
Outcome: 7 Endometritis

Von Rechenberg 1990 1/50 5/50 100.0 % 0.20 [ 0.02, 1.65 ]
Total (95% CI) 50 50 100.0 % 0.20 [ 0.02, 1.65 ]

0.02 0.1 1 10 50
Analysis 2.1. Comparison 2 Methods of performing the uterine incision: blunt versus sharp dissection,
Outcome 1 Postoperative febrile morbidity (including endometritis).
Comparison: 2 Methods of performing the uterine incision: blunt versus sharp dissection
Outcome: 1 Postoperative febrile morbidity (including endometritis)
Study or subgroup Blunt extension Sharp extension Risk Ratio Weight Risk Ratio
Hidar 2007 3/147 2/153 1.3 % 1.56 [ 0.26, 9.21 ]
Magann 2002 51/475 66/470 45.4 % 0.76 [ 0.54, 1.08 ]
Poonam 2006 7/200 14/200 9.6 % 0.50 [ 0.21, 1.21 ]
Rodriguez 1994 63/145 65/151 43.6 % 1.01 [ 0.78, 1.31 ]
Total (95% CI) 967 974 100.0 % 0.86 [ 0.70, 1.05 ]

Total events: 124 (Blunt extension), 147 (Sharp extension)
Heterogeneity: Chi2 = 3.80, df = 3 (P = 0.28); I2 =21%
0.1 0.2 0.5 1 2 5 10

Favours blunt Favours sharp
Outcome 2 Mean blood loss.
Mean Mean
Study or subgroup Blunt Sharp Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI
Magann 2002 475 843 (164) 470 886 (197) 52.0 % -43.00 [ -66.12, -19.88 ]
Sekhavat 2010 100 375 (95) 100 443 (86) 48.0 % -68.00 [ -93.12, -42.88 ]
Total (95% CI) 575 570 100.0 % -55.00 [ -79.48, -30.52 ]

Heterogeneity: Tau2 = 160.80; Chi2 = 2.06, df = 1 (P = 0.15); I2 =51%
-50 -25 0 25 50
Study or subgroup Blunt Sharp Risk Ratio Weight Risk Ratio

Magann 2002 2/475 9/470 43.0 % 0.22 [ 0.05, 1.01 ]
Poonam 2006 3/200 12/200 57.0 % 0.25 [ 0.07, 0.87 ]
Total (95% CI) 675 670 100.0 % 0.24 [ 0.09, 0.62 ]

Total events: 5 (Blunt), 21 (Sharp)
0.05 0.2 1 5 20
Outcome 4 Maternal death or serious morbidity.
Outcome: 4 Maternal death or serious morbidity
Study or subgroup Blunt Dissection Sharp Dissection Risk Ratio Weight Risk Ratio
Poonam 2006 1/200 0/200 100.0 % 3.00 [ 0.12, 73.20 ]
Total (95% CI) 200 200 100.0 % 3.00 [ 0.12, 73.20 ]

Total events: 1 (Blunt Dissection), 0 (Sharp Dissection)
0.01 0.1 1 10 100

Outcome 5 Duration of surgery.
Mean Mean
Study or subgroup Blunt Dissection Sharp Dissection Difference Weight Difference
Sekhavat 2010 100 27.9 (10.5) 100 30.7 (11.4) 100.0 % -2.80 [ -5.84, 0.24 ]
Total (95% CI) 100 100 100.0 % -2.80 [ -5.84, 0.24 ]

-100 -50 0 50 100

Analysis 3.1. Comparison 3 Methods of performing the uterine incision: transverse versus cephalad-caudad
blunt extension, Outcome 1 Mean blood loss.
Comparison: 3 Methods of performing the uterine incision: transverse versus cephalad-caudad blunt extension
Cephalad-
caudad Mean Mean
Study or subgroup Transverse extension extension Difference Weight Difference
Cromi 2008 406 440 (341) 405 398 (242) 100.0 % 42.00 [ 1.31, 82.69 ]
Total (95% CI) 406 405 100.0 % 42.00 [ 1.31, 82.69 ]

-100 -50 0 50 100

Favours transverse Favours cephalad
blunt extension, Outcome 2 Need for blood transfusion.
Cephalad-
caudad
Study or subgroup Transverse extension extension Risk Ratio Weight Risk Ratio
Cromi 2008 3/406 3/405 100.0 % 1.00 [ 0.20, 4.91 ]
Total (95% CI) 406 405 100.0 % 1.00 [ 0.20, 4.91 ]

Total events: 3 (Transverse extension), 3 (Cephalad-caudad extension)
0.01 0.1 1 10 100

blunt extension, Outcome 3 Duration of surgery.
Cephalad-
caudad Mean Mean
Study or subgroup Transverse extension extension Difference Weight Difference
Cromi 2008 406 38.9 (11.9) 405 40.4 (11.8) 100.0 % -1.50 [ -3.13, 0.13 ]
Total (95% CI) 406 405 100.0 % -1.50 [ -3.13, 0.13 ]

-100 -50 0 50 100

Analysis 4.1. Comparison 4 Single layer uterine closure versus double layer uterine closure, Outcome 1
Postoperative febrile morbidity (including endometritis).
Comparison: 4 Single layer uterine closure versus double layer uterine closure
Study or subgroup Single layer closure Double layer closure Risk Ratio Weight Risk Ratio
Bjorklund 2000 22/169 16/170 4.5 % 1.38 [ 0.75, 2.54 ]
CAESAR 2010 247/1483 249/1496 70.2 % 1.00 [ 0.85, 1.18 ]
CORONIS 2013 47/4639 47/4647 13.3 % 1.00 [ 0.67, 1.50 ]
Ferrari 2001 10/83 13/75 3.9 % 0.70 [ 0.32, 1.49 ]
Moreira 2002 5/200 2/200 0.6 % 2.50 [ 0.49, 12.74 ]
Poonam 2006 7/200 14/200 4.0 % 0.50 [ 0.21, 1.21 ]
Studzinski 2002 3/50 8/60 2.1 % 0.45 [ 0.13, 1.61 ]
Wallin 1999 2/36 1/36 0.3 % 2.00 [ 0.19, 21.09 ]
Xavier 2005 1/77 4/69 1.2 % 0.22 [ 0.03, 1.96 ]
Total (95% CI) 6937 6953 100.0 % 0.98 [ 0.85, 1.12 ]

Total events: 344 (Single layer closure), 354 (Double layer closure)
0.5 0.7 1 1.5 2

Favours single layer Favours double layer
Blood loss greater than 500 mL.
Outcome: 2 Blood loss greater than 500 mL
Bjorklund 2000 21/169 30/170 100.0 % 0.70 [ 0.42, 1.18 ]
Total (95% CI) 169 170 100.0 % 0.70 [ 0.42, 1.18 ]

0.1 0.2 0.5 1 2 5 10

Need for blood transfusion.
M- M-
H,Random,95% H,Random,95%
n/N n/N CI CI
CAESAR 2010 54/1483 59/1496 38.7 % 0.92 [ 0.64, 1.33 ]
CORONIS 2013 76/4639 79/4647 44.8 % 0.96 [ 0.71, 1.32 ]
Hauth 1992 9/457 11/449 10.9 % 0.80 [ 0.34, 1.92 ]
Poonam 2006 3/200 12/200 5.7 % 0.25 [ 0.07, 0.87 ]
Total (95% CI) 6779 6792 100.0 % 0.86 [ 0.63, 1.17 ]

0.1 0.2 0.5 1 2 5 10

Wound infection.
Outcome: 4 Wound infection
CAESAR 2010 188/1483 188/1496 29.5 % 1.01 [ 0.84, 1.22 ]
CORONIS 2013 353/4639 379/4647 59.7 % 0.93 [ 0.81, 1.07 ]
Hauth 1992 83/457 65/449 10.3 % 1.25 [ 0.93, 1.69 ]
Wallin 1999 1/36 1/36 0.2 % 1.00 [ 0.07, 15.38 ]
Xavier 2005 4/77 2/69 0.3 % 1.79 [ 0.34, 9.48 ]
Total (95% CI) 6692 6697 100.0 % 0.99 [ 0.89, 1.10 ]

0.05 0.2 1 5 20
Operative procedure on wound.
Outcome: 5 Operative procedure on wound
Bjorklund 2000 1/169 3/170 6.0 % 0.34 [ 0.04, 3.19 ]
CAESAR 2010 9/1483 9/1496 18.0 % 1.01 [ 0.40, 2.53 ]
CORONIS 2013 30/4639 38/4647 76.1 % 0.79 [ 0.49, 1.27 ]
Total (95% CI) 6291 6313 100.0 % 0.80 [ 0.53, 1.21 ]

0.05 0.2 1 5 20
Postoperative anaemia.
Outcome: 6 Postoperative anaemia
Bjorklund 2000 6/169 10/170 8.9 % 0.60 [ 0.22, 1.62 ]
Hauth 1992 112/457 101/449 91.1 % 1.09 [ 0.86, 1.38 ]
Total (95% CI) 626 619 100.0 % 1.05 [ 0.83, 1.32 ]

0.1 0.2 0.5 1 2 5 10

Complication of future pregnancy.
Outcome: 7 Complication of future pregnancy
Hauth 1992 1/70 0/75 100.0 % 3.21 [ 0.13, 77.55 ]
Total (95% CI) 70 75 100.0 % 3.21 [ 0.13, 77.55 ]

0.01 0.1 1 10 100

Postoperative pain present.
Outcome: 8 Postoperative pain present
M- M-
H,Random,95% H,Random,95%
n/N n/N CI CI
CORONIS 2013 203/4639 185/4647 52.3 % 1.10 [ 0.90, 1.34 ]
Ferrari 2001 38/83 50/75 47.7 % 0.69 [ 0.52, 0.91 ]
Total (95% CI) 4722 4722 100.0 % 0.88 [ 0.54, 1.42 ]

0.1 0.2 0.5 1 2 5 10

Complications post-op requiring re-laparotomy.
Outcome: 9 Complications post-op requiring re-laparotomy
CORONIS 2013 74/4639 87/4647 100.0 % 0.85 [ 0.63, 1.16 ]
Total (95% CI) 4639 4647 100.0 % 0.85 [ 0.63, 1.16 ]

0.01 0.1 1 10 100

Length of hospital stay.
Outcome: 10 Length of hospital stay
Mean Mean
Study or subgroup Single layer closure Double layer closure Difference Weight Difference
Ferrari 2001 83 4.8 (1.37) 75 4.9 (1.3) 100.0 % -0.10 [ -0.52, 0.32 ]
Total (95% CI) 83 75 100.0 % -0.10 [ -0.52, 0.32 ]

-10 -5 0 5 10
Death or serious maternal morbidity.
Outcome: 11 Death or serious maternal morbidity
CAESAR 2010 7/1483 11/1496 22.2 % 0.64 [ 0.25, 1.65 ]
CORONIS 2013 43/4639 38/4647 76.8 % 1.13 [ 0.73, 1.75 ]
Poonam 2006 1/200 0/200 1.0 % 3.00 [ 0.12, 73.20 ]
Total (95% CI) 6322 6343 100.0 % 1.04 [ 0.71, 1.54 ]

0.01 0.1 1 10 100

Maternal readmission.
Outcome: 12 Maternal readmission
CORONIS 2013 37/4639 33/4647 100.0 % 1.12 [ 0.70, 1.79 ]
Total (95% CI) 4639 4647 100.0 % 1.12 [ 0.70, 1.79 ]

0.01 0.1 1 10 100

Analysis 5.1. Comparison 5 Techniques for closing the uterus: chromic catgut versus polygactin-910,
Outcome 1 Postoperative febrile morbidity (including endometritis).
Comparison: 5 Techniques for closing the uterus: chromic catgut versus polygactin-910
Study or subgroup Catgut Polygactin Risk Ratio Weight Risk Ratio

CORONIS 2013 52/4954 69/4590 100.0 % 0.70 [ 0.49, 1.00 ]
Total (95% CI) 4954 4590 100.0 % 0.70 [ 0.49, 1.00 ]

Total events: 52 (Catgut), 69 (Polygactin)
0.5 0.7 1 1.5 2

Catgut Polygactin

CORONIS 2013 32/4954 60/4590 100.0 % 0.49 [ 0.32, 0.76 ]
Total (95% CI) 4954 4590 100.0 % 0.49 [ 0.32, 0.76 ]

0.1 0.2 0.5 1 2 5 10

Favours catgut Favours polygactin
Outcome 3 Wound infection.
Outcome: 3 Wound infection

CORONIS 2013 218/4954 204/4590 100.0 % 0.99 [ 0.82, 1.19 ]
Total (95% CI) 4954 4590 100.0 % 0.99 [ 0.82, 1.19 ]

0.05 0.2 1 5 20
Outcome 4 Operative procedure on wound.
Outcome: 4 Operative procedure on wound

CORONIS 2013 20/4954 29/4590 100.0 % 0.64 [ 0.36, 1.13 ]
Total (95% CI) 4954 4590 100.0 % 0.64 [ 0.36, 1.13 ]

0.05 0.2 1 5 20
Outcome 5 Postoperative pain present.
Outcome: 5 Postoperative pain present

CORONIS 2013 159/4954 171/4590 100.0 % 0.86 [ 0.70, 1.07 ]
Total (95% CI) 4954 4590 100.0 % 0.86 [ 0.70, 1.07 ]

0.1 0.2 0.5 1 2 5 10

Outcome 6 Complications post-op requiring re-laparotomy.
Outcome: 6 Complications post-op requiring re-laparotomy

CORONIS 2013 33/4954 53/4590 100.0 % 0.58 [ 0.37, 0.89 ]
Total (95% CI) 4954 4590 100.0 % 0.58 [ 0.37, 0.89 ]

0.01 0.1 1 10 100

Outcome 7 Death or serious maternal morbidity.
Outcome: 7 Death or serious maternal morbidity

CORONIS 2013 34/4954 46/4590 100.0 % 0.68 [ 0.44, 1.06 ]
Total (95% CI) 4954 4590 100.0 % 0.68 [ 0.44, 1.06 ]

0.01 0.1 1 10 100

Outcome 8 Maternal readmission.
Outcome: 8 Maternal readmission

CORONIS 2013 27/4954 25/4590 100.0 % 1.00 [ 0.58, 1.72 ]
Total (95% CI) 4954 4590 100.0 % 1.00 [ 0.58, 1.72 ]

0.01 0.1 1 10 100

APPENDICES
Appendix 1. Methods used to assess trials included in previous versions of this review
The following methods were used to assess Batioglu 1998; Bjorklund 2000; Dani 1998; Darj 1999; Ferrari 2001; Hamar 2007; Hauth
1992; Lal 1988; Magann 2002; Moreira 2002; Rodriguez 1994; Villeneuve 1990; Von Rechenberg 1990; Wallin 1999; Xavier 2005.
Two authors evaluated trials under consideration for appropriateness for inclusion and methodological quality without consideration
of their results according to the prestated eligibility criteria.
We assessed trials that met the eligibility criteria for quality using the following criteria:
1. generation of random allocation sequence: adequate, inadequate, unclear;
2. allocation concealment: A = adequate, B = unclear, C = inadequate;
3. blinding of participants: yes, no, inadequate, no information;
4. blinding of caregivers: yes, no, inadequate, no information;
5. blinding of outcome assessment: yes, no, inadequate, no information;
6. completeness of follow-up data (including any differential loss of participants from each group): (a) less than 3% of participants
excluded; (b) 3% to 9.9% of participants excluded; (c) 10% to 19.9% of participants excluded; (d) 20% or more excluded; and (e)
unclear;
7. analysis of participants in randomised groups.
Two authors extracted data independently. We resolved differences of opinion by discussion or referral to the primary editor. We
included in the ’Studies awaiting classification’ category studies reported only in abstract form that contained insufficient detail to allow
assessment of their eligibility or methods. They will be included in the analyses when published as full reports.
We combined data from different trials if they were sufficiently similar for this to be reasonable in the judgement of the authors.
We performed meta-analyses using risk ratios as the measure of effect size for binary outcomes, and mean differences for continuous
outcome measures.
We used fixed-effect meta-analysis for combining study data where the trials were judged to be sufficiently similar. We investigated
heterogeneity by calculating statistics (Higgins 2002), and if this indicated a high level of heterogeneity among the trials included in an
analysis, we used random-effects meta-analysis for an overall summary. We explored high levels of heterogeneity, where found, by the
prespecified subgroup analyses and by sensitivity analyses excluding trials most susceptible to bias based on the quality assessment: those
with inadequate allocation concealment; high levels of postrandomisation losses or exclusions; or unblinded outcome assessment, or
blinding of outcome assessment uncertain. However, this was not conducted due to the number of trials included in the meta-analysis.
Planned subgroup analyses were:
1. first versus repeat caesarean versus mixed/undefined;
2. prelabour versus intrapartum caesarean versus mixed/undefined;
3. preterm versus term caesarean versus mixed/undefined;
4. general versus regional anaesthesia versus mixed/undefined.
We investigated heterogeneity to assess the differences between the subgroups using the methods described by Deeks 2001.
WHAT’S NEW
Last assessed as up-to-date: 1 September 2013.
Date Event Description
1 September 2013 New citation required and conclusions have changed Twelve new trials included (CAESAR 2010; Ceci 2012;
Chitra 2004; CORONIS 2013; Cromi 2008; Gutierrez
2008; Hidar 2007; Poonam 2006; Sekhavat 2010; Sood
2005; Studzinski 2002; Yasmin 2011). For the compar-
ison, blunt versus sharp dissection when performing the
uterine incision, there is now additional evidence from
one study to suggest a significant reduction in the need
for blood transfusion with blunt extension
1 September 2013 New search has been performed Search updated and 30 trial reports identified.
HISTORY
Protocol first published: Issue 2, 2004
Review first published: Issue 3, 2008
Date Event Description
27 June 2012 Amended Search updated. Twenty-three reports added to Studies awaiting classification.
23 January 2008 Amended Converted to new review format
CONTRIBUTIONS OF AUTHORS
J Dodd drafted the original version of the protocol. J Dodd, E Anderson and S Gates were all involved in the development of the review,
including identification of studies, assessment for eligibility, data extraction and revision for content. J Dodd and R Grivell conducted
the assessment of studies and data extraction for the review update, and J Dodd and R Grivell drafted the text for the review update.
All authors contributed to revision for content.
DECLARATIONS OF INTEREST
S Gates and E Anderson are both involved in the CAESAR trial comparing single with double layer uterine closure.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

The title of the protocol was ’Surgical techniques for uterine closure involving the uterus at the time of caesarean section’. We have changed
the title of the review in response to feedback from reviewers. Methods updated.
INDEX TERMS
Medical Subject Headings (MeSH)
∗ SutureTechniques [instrumentation]; Abdominal Wound Closure Techniques; Blood Loss, Surgical; Cesarean Section [∗ methods];
Dissection [∗ methods]; Randomized Controlled Trials as Topic; Sutures; Time Factors
MeSH check words

Female; Humans; Pregnancy

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Cochrane Database of Systematic Reviews

Surgical techniques for uterine incision and uterine closure at

Dodd JM, Anderson ER, Gates S, Grivell RM

Dodd JM, Anderson ER, Gates S, Grivell RM.

Surgical techniques for uterine incision and uterine closure at

Jodie M Dodd1 , Elizabeth R Anderson2 , Simon Gates3 , Rosalie M Grivell1

Editorial group: Cochrane Pregnancy and Childbirth Group.

PLAIN LANGUAGE SUMMARY

1. different types of uterine incision;

Secondary outcomes Electronic searches

Longer-term outcome measures for the woman

Selection of studies (3.1) Blinding of participants and personnel (checking for

Continuous data Assessment of heterogeneity

Data synthesis Description of studies

Characteristics of included studies [ordered by study ID]

Methods Method of randomisation: not stated.

Notes Trial conducted in Turkey.

Risk of bias Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Not stated.

Allocation concealment (selection bias) Unclear risk Not stated.

Other bias Low risk Appears to be free of other bias.

Blinding of participants and personnel Unclear risk Not stated.

Blinding of outcome assessment (detection Unclear risk Not stated.

Methods Method of randomisation: computer-generated randomisation sequence.

Notes Trial conducted Dar es Salaam, Tanzania.

Risk of bias Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Computer-generated randomisation se-

Allocation concealment (selection bias) Low risk Sequential sealed envelopes.

Other bias Low risk Appears to be free of other bias.

Blinding of outcome assessment (detection High risk No blinding of outcome assessment.

Methods Method of randomisation: computer-generated randomisation sequence with minimi-

Participants 3033 women undergoing primary lower segment caesarean section

Interventions 1. Single versus double layer closure of uterus.

Notes Trial conducted in 45 sites in United Kingdom and 2 sites in Italy

Risk of bias Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Computer-generated randomisation se-

Allocation concealment (selection bias) Low risk Telephone randomisation service.

Selective reporting (reporting bias) Low risk Not apparent.

Other bias High risk Primary outcome modified after recruit-

Blinding of participants and personnel Unclear risk Not stated.

Blinding of outcome assessment (detection Low risk Blinded outcome assessment.

Methods Randomised trial.

Risk of bias Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk Random number sequence.

Allocation concealment (selection bias) Unclear risk Not specified.

Selective reporting (reporting bias) Unclear risk Unclear.

Other bias Unclear risk Unclear.

Methods Method of randomisation: stated to be ”randomly allocated by random numbers“.

Interventions Single versus double layer closure of uterus.

Outcomes Mean blood loss; operating time.

Notes Trial conducted in India.

Risk of bias Risk of bias

Bias Authors’ judgement Support for judgement

Allocation concealment (selection bias) Unclear risk Not stated.

Incomplete outcome data (attrition bias) Unclear risk Not stated.

Other bias Low risk Appears to be free of other bias.

Blinding of participants and personnel Unclear risk Not stated.

Blinding of outcome assessment (detection Unclear risk Not stated.

Methods Method of randomisation: computer-generated random number list.

Risk of bias Risk of bias