ACOG
PRACTICE
This Practice Bulletin was
developed by the ACOG Com-
mittee on Practice Bulletins—
Obstetrics with the assistance
of John Seeds, MD, and
Lyndon M. Hill, MD. The in-
formation is designed to aid
practitioners in making deci-
sions about appropriate obstet-
ric and gynecologic care. These
guidelines should not be con-
strued as dictating an exclusive
course of treatment or proce-
dure. Variations in practice may
be warranted based on the
needs of the individual patient,
resources, and limitations
unique to the institution or type
of practice.
VOL. 104, NO. 6, DECEMBER 2004
BULLETIN CLINICAL MANAGEMENT GUIDELINES FOR
OBSTETRICIAN–GYNECOLOGISTS
NUMBER 58, DECEMBER 2004
(Replaces Committee Opinion Number 180, November 1996, and
Practice Pattern Number 5, August 1997)
Ultrasonography in
Pregnancy
In the United States, approximately 65% of pregnant women have at least 1
ultrasound examination (1). The purpose of this document is to present
evidence regarding methodology, indications, benefits, and risks of obstetric
ultrasonography in specific clinical situations. Portions of this document were
developed collaboratively by the American College of Radiology, the American
Institute of Ultrasound in Medicine, and the American College of Obstetricians
and Gynecologists (ACOG). Sections of the document addressing physician
qualifications and responsibilities, documentation, quality control, infection
control, and patient education are recommendations of ACOG.
Background
Instrumentation
For most ultrasound examinations, an instrument with real-time, 2-dimension-
al imaging and sector or convex array abdominal transducers, typically with
frequencies ranging from 3 MHz to 7 MHz, or vaginal transducers, with fre-
quencies ranging from 5 MHz to 9 MHz, are used. Higher frequency transduc-
ers provide better resolution but with less penetration. Selection of transducer
frequency for a particular case should take into consideration this trade-off
between resolution and penetration. The equipment should allow the user to
perform on-screen linear and circumference measurements. A method for stor-
ing the images also is required. The equipment should be serviced at regular
intervals according to the manufacturer’s recommendations.
Two measurements of acoustic output are displayed on-screen with con-
temporary ultrasound equipment. The thermal index is an estimate of possible
tissue temperature increase that may be caused by ultrasound absorption. The
mechanical index is a measure of the interaction of ultrasonography with
microscopic gas bubbles that are present in all tissues. The mechanical index
ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy 1449
incorporates cavitation with other possible nonthermal
effects of ultrasonography. When the thermal index and
mechanical index are adjusted by the user to values of Essential Elements of Fetal Anatomic
less than unity (1), the likelihood of tissue effect is very Ultrasound Survey
low (2). Most machines allow adjustment of output and
Head and Neck
will instantly recalculate and display the new thermal
index and mechanical index. • Cerebellum
Most manufacturers now offer machines capable of • Choroid plexus
3-dimensional surface rendering of fetal anatomy, and • Cisterna magna
some offer near real-time 3-dimensional imaging. Proof • Lateral cerebral ventricles
of a clear advantage of 3-dimensional ultrasonography in
prenatal diagnosis is not present when compared with • Midline falx
2-dimensional imaging by an experienced clinician. • Cavum septi pellucidi
Therefore, 3-dimensional imaging is not considered a
Chest
required modality at this time.
• The basic cardiac examination includes a 4-chamber
Types of Examinations view of the fetal heart. If technically feasible, an
extended basic cardiac examination also can be
The American College of Obstetricians and Gynecologists attempted to evaluate both outflow tracts.
uses the terms “standard,” “limited,” and “specialized” to
describe various types of ultrasound examinations per- Abdomen
formed during the second or third trimesters. Although • Stomach (presence, size, and situs)
the standard and limited examinations are defined by • Kidneys
their components, the specialized examination is defined • Bladder
by the indications for the examination, that is, the circum-
stances that suggest a more thorough ultrasound examina- • Umbilical cord insertion site into the fetal
abdomen
tion is needed. First-trimester obstetric ultrasonography
is distinct from these and is discussed separately. • Umbilical cord vessel number
Spine
Standard Examination
• Cervical, thoracic, lumbar, and sacral spine
A standard examination is performed during the second
or third trimester of pregnancy. It includes an evaluation Extremities
of fetal presentation, amniotic fluid volume, cardiac • Legs and arms (presence or absence)
activity, placental position, fetal biometry, and an
anatomic survey. If technically feasible, the uterus and Sex
adnexa also are examined. • For evaluation of multiple gestations
Fetal anatomy, as described in this document, may American College of Radiology. ACR practice guideline for the per-
be assessed adequately by ultrasonography after approx- formance of antepartum obstetrical ultrasound. In: ACR practice
imately 16–20 weeks of gestation. It may be possible to guidelines and technical standards, 2003. Philadelphia (PA): ACR;
2003. p. 625–31.
document normal structures before this time, although
some structures can be difficult to visualize because of
fetal size, position, movement, abdominal scars, and
increased maternal wall thickness. A second- or third-
trimester ultrasound examination may pose technical
limitations for an anatomic evaluation because of imag- Limited Examination
ing artifacts from acoustic shadowing. When this occurs, A limited examination is performed when a specific
the report of the ultrasound examination should docu- question requires investigation. In an emergency, for
ment the nature of this technical limitation. example, a limited examination can be performed to eval-
The essential elements of a standard examination of uate heart activity in a bleeding patient. This evaluation
fetal anatomy are listed in the box. A more detailed fetal also would be appropriate for verifying fetal presentation
anatomic examination may be necessary if an abnormal- in a laboring patient; however, in most cases, a limited
ity or suspected abnormality is found on the standard examination is appropriate only when the patient has had
examination. a prior complete examination.

1450 ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy OBSTETRICS & GYNECOLOGY
Specialized Examination
A detailed or targeted anatomic examination is per-
formed when an anomaly is suspected on the basis of
history, biochemical abnormalities or clinical evaluation,
or suspicious results from either the limited or standard
ultrasound examination. Other specialized examinations
might include fetal Doppler, biophysical profile, fetal
echocardiography, or additional biometric studies.
Specialized examinations are performed by an operator
with experience and expertise in such ultrasonography
who determines the components of the examination on a
case-by-case basis.
First-Trimester Ultrasonography
Indications. An ultrasound examination may be of ben-
efit in many circumstances in the first trimester of preg-
nancy, including, but not limited to, the following
indications:
• To confirm the presence of an intrauterine pregnancy
• To evaluate a suspected ectopic pregnancy
• To define the cause of vaginal bleeding
• To evaluate pelvic pain
• To estimate gestational age
• To diagnose or evaluate multiple gestations
• To confirm cardiac activity
• As an adjunct to chorionic villus sampling, embryo
transfer, or localization and removal of an intrauter-
ine device
• To evaluate maternal pelvic masses or uterine
abnormalities
• To evaluate suspected hydatidiform mole
Imaging Parameters. Ultrasonography in the first
trimester may be performed either transabdominally
or transvaginally. If a transabdominal examination is
not definitive, a transvaginal or transperineal exami-
nation should be performed whenever possible. The
following factors should be considered during the
examination:
• The uterus and adnexa should be evaluated for the
presence of a gestational sac. If a gestational sac is
seen, its location should be documented. The gesta-
tional sac should be evaluated for the presence or
absence of a yolk sac or embryo, and the crown–
rump length should be recorded, when possible. The
crown–rump length is a more accurate indicator of
gestational age than is the mean gestational sac
diameter. However, the mean gestational sac diame-
VOL. 104, NO. 6, DECEMBER 2004
ter should be recorded when an embryo is not
identified. Caution should be used in making the
presumptive diagnosis of a gestational sac in the
absence of a definite embryo or yolk sac. Without
these findings, an intrauterine fluid collection could
represent a pseudogestational sac associated with an
ectopic pregnancy.
• Presence or absence of cardiac activity should be
reported. With transvaginal ultrasound examina-
tions, cardiac motion usually is observed when the
embryo is 5 mm or greater in length. If an embryo
less than 5 mm in length is seen without cardiac
activity, an additional ultrasound examination at
a later time may be needed to document cardiac
activity.
• Fetal number should be reported. Amnionicity and
chorionicity should be documented for all multiple
pregnancies when possible.
• Evaluation of the uterus, adnexal structures, and cul-
de-sac should be performed. The presence, location,
and size of leiomyomata and adnexal masses should
be recorded. The cul-de-sac should be evaluated by
ultrasonography for the presence or absence of
fluid.
Second- and Third-Trimester
Ultrasonography
Indications. In 1984, the U.S. Department of Health and
Human Services published a list of 27 indications for an
obstetric ultrasound examination. Since then, advances
in ultrasonographic technology have increased the list of
indications (see box).
Imaging Parameters. The components of a standard
fetal examination are as follows:
• Fetal cardiac activity, number, and presentation
should be reported. Abnormal heart rate or rhythm
should be reported. For multiple pregnancies,
additional information should be documented: cho-
rionicity, amnionicity, comparison of fetal sizes,
estimation of amniotic fluid volume (increased,
decreased, or normal) on each side of the mem-
brane, and fetal genitalia (when visualized).
• A qualitative or semiquantitative estimate of amni-
otic fluid volume should be reported. Although it is
acceptable for experienced examiners to estimate
the amniotic fluid volume qualitatively, semiquanti-
tative methods also have been described for this
purpose (eg, amniotic fluid index, single deepest
pocket, 2-diameter pocket).
ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy 1451
 • The placenta’s location, appearance, and relationship
to the internal cervical os should be recorded. The
umbilical cord should be imaged, and the number of
Indications for Ultrasonography During Pregnancy
• Estimation of gestational age for patients with uncer-
tain clinical dates, or verification of dates for patients
who are to undergo scheduled elective repeat
cesarean delivery, indicated induction of labor, or
other elective termination of pregnancy
• Evaluation of fetal growth
• Vaginal bleeding of undetermined etiology in
pregnancy
• Evaluation of incompetent cervix
• Abdominal and pelvic pain
• Determination of fetal presentation
• Suspected multiple gestation
• Adjunct to amniocentesis
• Significant uterine size and clinical dates
discrepancy
• Pelvic mass
• Suspected hydatidiform mole
• Adjunct to cervical cerclage placement
• Suspected ectopic pregnancy
• Suspected fetal death
• Suspected uterine abnormality
• Biophysical evaluation for fetal well-being
• Suspected polyhydramnios or oligohydramnios
• Suspected abruptio placentae
• Adjunct to external version from breech to vertex
presentation
• Estimation of fetal weight or presentation in
premature rupture of membranes or premature
labor
• Evaluation of abnormal serum screening value
• Follow-up observation of identified fetal anomaly
• Follow-up evaluation of placental location for identi-
fied “placenta previa”
• History of previous congenital anomaly
• Evaluation of fetal condition in late registrants for
prenatal care
American College of Radiology. ACR practice guideline for the per-
formance of antepartum obstetrical ultrasound. In: ACR practice
guidelines and technical standards, 2003. Philadelphia (PA): ACR;
2003. p. 625–31.
1452 ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy
vessels in the cord should be evaluated when possi-
ble. The apparent placental position early in preg-
nancy may not correlate well with its location at the
time of delivery. Therefore, if low-lying placenta or
placenta previa are suspected early in gestation, ver-
ification in the third trimester by repeat ultrasonog-
raphy is indicated. Transabdominal, transperineal, or
transvaginal views may be helpful in visualizing the
internal cervical os and its relationship to the
placenta.
• Gestational age should be assessed. First-trimester
crown–rump measurement is the most accurate
means of ultrasound dating of pregnancy. Beyond
this period, a variety of ultrasonographic parameters,
such as biparietal diameter, abdominal circumfer-
ence, and femoral diaphysis length, can be used to
estimate gestational age. The variability of gestation-
al age estimations, however, increases with advanc-
ing pregnancy. Significant discrepancies between the
estimated gestational age and fetal measurements
from later ultrasound examinations may suggest the
possibility of a fetal growth abnormality, intrauterine
growth restriction (IUGR), or macrosomia.
— Biparietal diameter usually is measured at the
level of the thalami and cavum septi pellucidi.
The cerebellar hemispheres should not be visible
in this scanning plane. The measurement is taken
from the outer edge of the proximal skull to the
inner edge of the distal skull. The head shape may
be flattened (dolichocephaly) or rounded (brachy-
cephaly) as a normal variant. These variants of
normal fetal head development may make meas-
urement of the head circumference more reliable
than biparietal diameter for estimating gesta-
tional age.
— Head circumference is measured at the same level
as the biparietal diameter, around the outer
perimeter of the calvarium. This measurement is
not affected by head shape.
— Femoral diaphysis length can be reliably used
after 14 weeks of gestational age. The long axis
of the femur shaft is most accurately measured
with the beam of insonation being perpendicu-
lar to the shaft, excluding the distal femoral
epiphysis.
— Abdominal circumference should be determined
at the skin line on a true transverse view at the
level of the junction of the umbilical vein, portal
sinus, and fetal stomach when visible. Abdominal
circumference measurement is used with other
biometric parameters to estimate fetal weight and
may allow detection of IUGR or macrosomia.
OBSTETRICS & GYNECOLOGY
 • Fetal weight can be estimated by obtaining measure-
ments such as the biparietal diameter, head circum-
ference, abdominal circumference, and femoral
diaphysis length. Results from various prediction
models can be compared with fetal weight per-
centiles from published nomograms. If previous
studies have been performed, interval measurement
changes also should be evaluated for growth.
Ultrasound examinations for growth evaluation can
typically be performed no less than 2 weeks apart. A
shorter interval between ultrasound examinations
may result in confusion as to whether anatomic
changes are truly caused by growth as opposed to
variations in the measurement technique itself.
• Evaluation of the maternal uterus and adnexal struc-
tures should be performed. Such evaluation will
allow recognition of incidental findings of potential
clinical significance. The presence, location, and
size of leiomyomata and adnexal masses should be
recorded. Frequently, it is not possible to image the
normal maternal ovaries during the second and third
trimesters.
Ultrasound Facility Accreditation
Recently, the American Institute of Ultrasound in
Medicine and the American College of Radiology have
offered ultrasound facility accreditation. This process
involves review of equipment use and maintenance,
report generation, storage of images, and ultrasono-
grapher and physician qualifications. Practices, not
individuals, may be accredited in ultrasonography for
obstetrics, gynecology, or both.
Physicians who perform, evaluate, and interpret
diagnostic obstetric ultrasound examinations should be
licensed medical practitioners with an understanding of
the indications for such imaging studies, the expected
content of a complete obstetric ultrasound examination,
and a familiarity with the limitations of ultrasound imag-
ing. They should be familiar with the anatomy, physiolo-
gy, and pathophysiology of the pelvis, the pregnant
uterus, and the fetus. These physicians should have
undergone specific training in obstetric ultrasonography
either during or since their residency training and should
be able to document this training. Physicians active in
obstetric ultrasonography should regularly review and
update their expertise in this area through postgraduate
medical education. Completion of an approved residency
in obstetrics and gynecology with documentation of
obstetric ultrasound experience and training with certifi-
cation by the American Board of Obstetrics and
Gynecology is evidence of the necessary and appropriate
training.
VOL. 104, NO. 6, DECEMBER 2004
Physicians are responsible for the quality and accu-
racy of ultrasound examinations performed in their
names regardless of whether they personally produced
the images. Physicians are responsible for the quality of
the documentation of examinations and the quality con-
trol and safety of the environments and the procedures.
Documentation
Appropriate documentation of an obstetric or gyneco-
logic ultrasound examination is essential to both direct
clinical care and quality assurance. Complete documen-
tation of the biometric data produced and the maternal
and fetal anatomy examined are necessary both to sup-
port clinical assessment and decision making as well as
to support a conclusion that recommended guidelines
were satisfied by the study. An adequate written report of
findings may be provided either through the completion
of a carefully designed preprinted template that includes
the biometry and specific anatomic areas examined as
recommended by these guidelines or through the creation
of a unique narrative report that includes all findings. It
should be the goal of practitioners to document in the
medical record their efforts during ultrasound examina-
tions to methodically examine all fetal anatomy and
measure all relevant dimensions. The report should be
complete but easy to interpret.
Quality review is facilitated by storing the appropri-
ate images in the medical record or in another easily
accessed but secure location. The images stored should
include images of fetal biometry as well as anatomy. The
images may be in the form of thermal paper prints or
other media with appropriate storage durability.
Videotape provides more extensive visual documentation
for review. Absence of visual image documentation elim-
inates the possibility of future review or clinical reinter-
pretation and weakens the defense against an allegation
that an incomplete or inadequate study was performed.
Quality Control, Performance
Improvement, Safety, and Patient
Education
Ideally, quality control is accomplished through careful
recordkeeping of obstetric ultrasound examination
results, reliable archival of reports and images, and clini-
cal correlation with clinical outcomes. The ultimate qual-
ity standard of any imaging study is to correlate the study
findings with clinical outcomes. Any practice active in
obstetric ultrasonography should maintain such records
and make every effort to correlate imaging results with
ultimate clinical outcome data.
Ultrasound transducers, like any instrument used on
a patient, present the possibility of microbial transmis-
ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy 1453
sion if not properly cleaned between patients. Trans-
abdominal ultrasonography is not completely free of this
risk, although the risk is substantially lower than it is for
endovaginal ultrasonography. Transabdominal transduc-
ers may be adequately cleansed between patients simply
by wiping with a disposable antiseptic paper towelette.
Endovaginal transducers should always be covered with a
single-use disposable latex or nonlatex cover. However,
disposable protective covers are not without risk of rup-
ture or defect, and it is recommended that endovaginal
transducers undergo appropriate antimicrobial cleansing,
if not chemical sterilization, between uses.
Practitioners are encouraged to regularly update and
review their ultrasound skills through accredited post-
graduate medical education. Before an ultrasound exam-
ination is performed, patients should be counseled about
the limitations of ultrasonography for diagnosis.
Clinical Considerations and
Recommendations
▲
How safe is ultrasonography for the fetus?
Ultrasonography should be performed only when there
is a valid medical indication, and the lowest possible
ultrasonic exposure setting should be used to gain the
necessary diagnostic information under the as low as rea-
sonably achievable (ALARA) principle. From a medical
standpoint, fetal ultrasonography is considered safe when
properly used and when medical information about a
pregnancy is needed; however, ultrasound energy deliv-
ered to the fetus cannot be assumed to be completely
innocuous. Diagnostic levels of ultrasonography can pro-
duce physical effects, such as mechanical vibrations
(referred to as cavitation), or an increase in tissue tem-
perature under laboratory conditions.
Although there is no reliable evidence of physical
harm to human fetuses from diagnostic ultrasound imag-
ing, public health experts, clinicians, and industry repre-
sentatives agree that casual use of ultrasonography,
especially during pregnancy, should be avoided. Viewed
in this light, exposing the fetus to ultrasonography with
no anticipation of medical benefit is not justified (3–5).
The U.S. Food and Drug Administration views the pro-
motion, sale, or lease of ultrasound equipment for mak-
ing “keepsake” fetal videos as an unapproved use of a
medical device; use of ultrasonography without a physi-
cian’s order may be a violation of state or local laws or
regulations regarding the use of a prescription medical
device (6). Specific indications are the best basis for
ultrasonography in pregnancy.
1454 ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy
Should all patients be offered ultrasonography?
▲
It has been suggested that all patients be offered routine
ultrasound screening. It has been shown, for example,
that 90% of infants with congenital anomalies are born to
women with no risk factors (7). However, several studies
conducted between 1985 and 1994 found routine
ultrasound screening yielded no consistent impact on
perinatal morbidity or mortality (8–11). In the screened
populations, the detection rate for congenital anomalies
ranged from 16% to 85%. A subsequent secondary analy-
sis of these studies concluded that routine screening was
cost-effective (12). Using a mathematical model to eval-
uate further the published study results, other researchers
concluded that routine screening at tertiary centers would
be cost-effective, but screening in nontertiary centers
resulted in a net loss (13).
Given the limitations of the evidence, a physician is
not obligated to perform ultrasonography in a patient who
is at low risk and has no indications. However, if a patient
requests ultrasonography, it is reasonable to honor the
request. The decision ultimately rests with the physician
and patient jointly.
What gestational age represents the optimal
▲
time for an obstetric ultrasound examination?
The optimal time for obstetric ultrasound examination is
the first trimester in the case of a pregnancy resulting
from ovulation induction or other assisted reproductive
technologies, bleeding in the first trimester, hyperemesis
gravidarum, previous ectopic pregnancy, significant
abdominal pain, or possibly increased risk of fetal aneu-
ploidy. If none of these indications apply, 16–20 weeks of
gestation is an appropriate time to obtain an accurate esti-
mate of gestational age and a reasonable survey of fetal
anatomy. Although gestational age derived from
crown–rump length in the first trimester is statistically
more precise than the average estimated gestational age
found in the second trimester, the difference in precision
is not clinically important, and a complete anatomic
assessment is not possible in the first trimester. Therefore,
the optimal timing for a single ultrasound examination in
the absence of specific indications for a first-trimester
examination is 16–20 weeks of gestation.
▲
How may ultrasonography be used to detect
chromosomally abnormal fetuses in the second
trimester in women at high risk?
A second-trimester specialized ultrasound examination
may be targeted to detect fetal aneuploidy. This type of
examination has been offered in some centers for the past
several years and is aimed at the detection of a range of
OBSTETRICS & GYNECOLOGY
minor anatomic features associated with an increased
risk of fetal aneuploidy. Advanced maternal age or an
abnormal first- or second-trimester multiple marker
screen indicating an increased risk for Down syndrome
are among the indications for a specialized ultrasound
examination. The standard ultrasound examination is
less likely to detect the minor anatomic features associ-
ated with aneuploidy. There are to date no uniformly
agreed-on criteria for such a specialized ultrasonogram.
Furthermore, such minor anatomic markers for aneu-
ploidy have been studied mainly in high-prevalence
referral populations in which the predictive value is
much higher than it would be in a low-prevalence
population.
To date, no randomized controlled trials have evalu-
ated the efficacy of a specialized ultrasound examination
in the detection of karyotypically abnormal fetuses. The
studies that have been performed indicate a range rather
than a single estimate of sensitivity. Hence, evidence is
insufficient to support or refute the general use of a spe-
cialized ultrasound examination to evaluate the entire at-
risk obstetric population. The use of the ultrasound
markers developed in high-prevalence patient popula-
tions in screening for Down syndrome in a low-risk pop-
ulation in the second trimester currently is premature.
▲
How is ultrasonography used to detect distur-
bances in fetal growth?
Intrauterine Growth Restriction
Intrauterine growth restriction is an outcome associated
with a multitude of etiologies. The effect on the fetus
varies depending on the etiology, time of onset, and
severity of the growth restricting process. Individual
prognosis, therefore, varies widely.
Generally, a birth weight below the 10th percentile
for gestational age using a representative reference
nomogram has been the most common definition of
IUGR. By definition, 10% of infants in any population
will have birth weights at or below the 10th percentile.
However, IUGR could be manifest at a weight above the
population determined at the 10th percentile (eg, an
undernourished infant born at the 15th percentile whose
genetic makeup would have resulted in greater growth).
Distinctions between normal and pathologic growth
often cannot be made reliably in clinical practice, espe-
cially before birth. A substantial proportion of infants
with birth weights below the 10th percentile are not
pathologically growth restricted but instead simply
reflect familial or ethnic growth patterns.
Although defining a pathologic condition using a
10th percentile cutoff makes statistical sense, it may not
VOL. 104, NO. 6, DECEMBER 2004
be clinically relevant. One study suggests that adverse
perinatal outcome generally is confined to those infants
with birth weights below the 5th percentile and, in most
cases, below the 3rd percentile (14).
Four standard fetal measurements generally are
obtained as part of any complete obstetric ultrasound
examination after the first trimester: 1) fetal abdominal
circumference, 2) head circumference, 3) biparietal
diameter, and 4) femur length (15). Fetal morphologic
parameters can be converted to fetal weight estimates
using published formulas and tables (16). All such meth-
ods carry an inherent variance or error. Contemporary
ultrasound equipment calculates and displays an esti-
mate of fetal weight on the basis of these formulas. An
abdominal circumference within the normal range reli-
ably excludes growth restriction with a false-negative
rate of less than 10% (17). A small abdominal circum-
ference or fetal weight estimate below the 10th per-
centile suggests the possibility of growth restriction,
with the likelihood increasing as the percentile rank
decreases (17). When IUGR is suspected, serial meas-
urements of fetal biometric parameters provide an esti-
mated growth rate. Such serial measurements are of
considerable clinical value in confirming or excluding
the diagnosis and assessing the progression and severity
of growth restriction. Given the high incidence of genetic
and structural defects associated with IUGR, a detailed
ultrasound survey for the presence of fetal structural and
functional defects may be indicated. The sensitivity of
fetal biometry for the detection of IUGR varies between
25% and 94% (Table 1). None of the randomized con-
trolled trials in low-risk patients support a recommenda-
tion for screening for IUGR.
Amniotic fluid volume is an important diagnostic
and prognostic parameter in fetuses with IUGR (18, 19).
Oligohydramnios is highly suggestive of growth failure
and indicates an increased risk of fetal death.
Oligohydramnios is diagnosed by ultrasonography in
approximately 77–83% of pregnancies with growth-
restricted fetuses (18–20). In contrast, amniotic fluid
volume often is normal even in a fetus with significant
growth restriction; thus, the absence of oligohydramnios
should not diminish the importance of the diagnosis of
IUGR.
Although Doppler velocimetry of the umbilical
arteries is not useful as a screening technique for IUGR
(21, 22), it has been demonstrated to be useful once
IUGR has been diagnosed. Not only can Doppler
velocimetry findings be normal in growth-restricted
fetuses with chromosomal or other structural etiologies
(23), but Doppler velocimetry has been shown to both
reduce interventions and improve fetal outcome in preg-
nancies at risk for IUGR (24). Thus, once IUGR is sus-
ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy 1455
 Table 1. Randomized Controlled Trials Evaluating the Antenatal Diagnosis of Intrauterine
Growth Restriction

Intrauterine Growth Restriction

Author Year Population No. Screened N % Detected
Bakketeig* 1984 Low risk 510 41 25
†
Neilson 1984 Low risk 433 33 94
Secher‡ 1987 Low risk 2,771 267 31.1
Larsen§ 1992 High risk 484 64 67
Duff|| 1993 Low risk 760 32 60
¶
Ewigman 1993 Low risk 7,812 176 —
*Bakketeig LS, Eik-Nes SH, Jacobsen G, Ulstein MK, Brodtkorb CJ, Balstad P, et al. Randomized controlled trial of ultrasono-
graphic screening in pregnancy. Lancet 1984;2:207–11.
†
Neilson J, Munjanja SP, Whitfield CR. Screening for small for dates fetuses: a controlled trial. Br Med J (Clin Res Ed) 1984;
289:1179–82.
‡
Secher NJ, Kern Hansen P, Lenstrup C, Sindberg Eriksen P, Morsing G. A randomized study of fetal abdominal diameter and
fetal weight estimation for detection of light-for-gestation infants in low-risk pregnancies. Br J Obstet Gynaecol 1987;94:105–9.
§
Larsen T, Larsen JF, Petersen S, Greisen G. Detection of small-for-gestational-age fetuses by ultrasound screening in a high risk
population: a randomized controlled trial. Br J Obstet Gynaecol 1992;99:469–74.
||
Duff GB. A randomized controlled trail in a hospital population of ultrasound measurement screening for the small for dates
baby. Aust N Z J Obstet Gynaecol 1993;33:374–8.
¶
Ewigman BG, Crane JP, Frigoletto FD, LeFevre ML, Bain RP, McNellis D. Effect of prenatal ultrasound screening on perinatal
outcome. RADIUS Study Group. N Engl J Med 1993;329:821–7.

pected or diagnosed, Doppler velocimetry may be useful
as a part of fetal evaluation. Fetuses with normal flow
patterns seem less likely to benefit from consideration of
early delivery than do their counterparts with abnormal
studies.
Identification of IUGR is improved by recording
growth velocity or through 2 sets of examinations gener-
ally 2–4 weeks apart. Serial ultrasonograms to determine
the rate of growth should be obtained approximately
every 2–4 weeks. Measurements at shorter intervals
(<2 weeks) may overlap and cause measurement errors.
Macrosomia
Macrosomia implies growth beyond a specific weight,
usually 4,000 g or 4,500 g, regardless of gestational age
(25–27). Numerous fetal body dimensions have been
evaluated in an attempt to estimate fetal weight more
reliably. Although all of the published formulas for esti-
mating fetal weight show a good correlation with birth
weight, the variability of the estimate generally is plus or
▲
Among women without diabetes, ultrasound biometry
used to detect macrosomia has a sensitivity of 22–44%,
a specificity of 99%, a positive predictive value of
30–44%, and a negative predictive value of 97–99% (30,
31). It was only later that the clinical and ultrasono-
graphic estimates of fetal weight were compared. These
investigations reported no difference between ultrasound
and clinical measurements in the prediction of macroso-
mia (32, 33).
The true value of ultrasonography in the manage-
ment of expected fetal macrosomia may be its ability to
rule out the diagnosis. The standard deviation of ultra-
sound estimates of fetal weight is too large to allow the
weight estimate to be used independently in clinical
decision making (34).
Conclusions

Ultrasound examination is an accurate method of

minus 16–20% (2 standard deviations) (28). In addition,
most of the formulas currently in use have a greater error
when the fetus has macrosomia. For example, one study
reported a mean absolute percent error for a fetal weight
▲
determining gestational age, fetal number, viability,
and placental location. Gestational age is most accu-
rately determined in the first half of pregnancy.

estimate of 12.6% for fetuses greater than 4,500 g and The ability of ultrasonography to diagnose major
8.4% for fetuses less than 4,500 g (P <.001) (29). fetal anomalies is well established.
▲

The initial studies of macrosomia established the The diagnosis of fetal growth abnormalities with
accuracy of the ultrasound estimation of fetal weight (28). ultrasonography is not precise.

1456 ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy OBSTETRICS & GYNECOLOGY
▲
Ultrasonography is safe for the fetus when used
appropriately.
▲
Specific indications are the best basis for the use of
ultrasonography in pregnancy.
▲
The optimal timing for a single ultrasound exami-
nation in the absence of specific indications for a
first-trimester examination is at 16–20 weeks of
gestation.
Summary of
Recommendations
The following recommendation is based on limit-
ed or inconsistent scientific evidence (Level B):
Serial ultrasonograms to determine the rate of
▲
growth should be obtained approximately every
2–4 weeks.
The following recommendations are based primar-
ily on consensus and expert opinion (Level C):
Casual use of ultrasonography, especially during
▲
pregnancy, should be avoided.
▲
Before an ultrasound examination is performed,
patients should be counseled about the limitations of
ultrasonography for diagnosis.
References
1. Martin JA, Hamilton BE, Sutton PD, Ventura SJ,
Menacker F, Munson ML. Births: final data for 2002. Natl
Vital Stat Rep 2003;52(10):1–113. (Level II-3)
2. American Institute of Ultrasound in Medicine. Acoustic
output measurement standards for diagnostic ultrasound
equipment. Laurel (MD): AIUM; 1998. (Level III)
3. Stark CR, Orleans M, Haverkamp AD, Murphy J. Short-
and long-term risks after exposure to diagnostic ultrasound
in utero. Obstet Gynecol 1984;63:194–200. (Level II-2)
4. Lyons EA, Dyke C, Toms M, Cheang M. In utero expo-
sure to diagnostic ultrasound: a 6-year follow-up. Radiol-
ogy 1988;166:687–90. (Level II-2)
5. American Institute of Ultrasound in Medicine. Bioeffects
of diagnostic ultrasound with gas body contrast agents.
Laurel (MD): AIUM; 2002. (Level III)
6. Rados C. FDA cautions against ultrasound “keepsake”
images. FDA Consum 2004;38(1):12–6. (Level III)
7. Long G, Sprigg A. A comparative study of routine versus
selective fetal anomaly ultrasound scanning. J Med
Screen 1998;5:6–10. (Level III)
8. Ewigman BG, Crane JP, Frigoletto FD, LeFevre ML, Bain
RP, McNellis D. Effect of prenatal ultrasound screening
VOL. 104, NO. 6, DECEMBER 2004
on perinatal outcome. RADIUS Study Group. N Engl J
Med 1993;329:821–7. (Level I)
9. Saari-Kemppainen A, Karjalainen O, Ylostalo P,
Heinonen OP. Fetal anomalies in a controlled one-stage
ultrasound screening trial. A report from the Helsinki
Ultrasound Trial. J Perinatal Med 1994;22:279–89.
(Level I)
10. Bucher H, Schmidt JG. Does routine ultrasound scanning
improve outcome of pregnancy? Meta-analysis of various
outcome measures. BMJ 1993;307:13–7. (Meta-analysis)
11. Crane JP, LeFevre ML, Windborn RC, Evans JK,
Ewigman BG, Bain RP, et al. A randomized trial of pre-
natal ultrasonographic screening: impact on the detection,
management and outcome of anomalous fetuses. The
RADIUS Study Group. Am J Obstet Gynecol 1994;171:
392–9. (Level I)
12. Leivo T, Tuominen R, Saari-Kemppainen A, Ylostalo P,
Karjalainen O, Heinonen OP. Cost-effectiveness of one-
stage ultrasound screening in pregnancy: a report from the
Helsinki ultrasound trial. Ultrasound Obstet Gynecol
1996;7:309–14. (Level III)
13. Vintzileos AM, Ananth CV, Smulian JC, Beazoglou T,
Knuppel RA. Routine second-trimester ultrasonography
in the United States: a cost-benefit analysis. Am J Obstet
Gynecol 2000;182:655–60. (Level III)
14. McIntire DD, Bloom SL, Casey BM, Leveno KJ. Birth
weight in relation to morbidity and mortality among
newborn infants. N Engl J Med 1999;340:1234–8.
(Level II-2)
15. Hadlock FP, Deter RL, Harrist RB, Park SK. Estimat-
ing fetal age: computer-assisted analysis of multiple
fetal growth parameters. Radiology 1984;152:497–501.
(Level II-3)
16. Shepard MJ, Richards VA, Berkowitz RL, Warsof SL,
Hobbins JC. An evaluation of two equations for predicting
fetal weight by ultrasound. Am J Obstet Gynecol 1982;
142:47–54. (Level III)
17. Warsof SL, Cooper DJ, Little D, Campbell R. Routine
ultrasound screen for antenatal detection of intrauter-
ine growth retardation. Obstet Gynecol 1986;67:33–9.
(Level II-2)
18. Chamberlain PF, Manning FA, Morrison I, Harman CR,
Lange IR. Ultrasound evaluation of amniotic fluid vol-
ume. I. The relationship of marginal and decreased amni-
otic fluid volumes to perinatal outcome. Am J Obstet
Gynecol 1984:150:245–9. (Level II-3)
19. Varma TR, Bateman S, Patel RH, Chamberlain GV, Pillai
U. Ultrasound evaluation of amniotic fluid: outcome of
pregnancies with severe oligohydramnios. Int J Gynaecol
Obstet 1988;27:185–92. (Level II-2)
20. Philipson EH, Sokol RJ, Williams T. Oligohydraminios:
clinical associations and predictive value for intrauterine
growth retardation. Am J Obstet Gynecol 1983;146:
271–8. (Level II-2)
21. Davies JA, Gallivan S, Spencer JA. Randomised con-
trolled trial of Doppler ultrasound screening of placental
perfusion during pregnancy. Lancet 1992;340:1299–303.
(Level I)
ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy 1457
22. Low JA. The current status of maternal and fetal blood
flow velocimetry. Am J Obstet Gynecol 1991;164:1049–63.
(Level III)
23. Wladimiroff JW, vd.Wijngaard JA, Degani S, Noordam
MJ, van Eyck J, Tonge HM. Cerebral and umbilical arteri-
al blood flow velocity waveforms in normal and growth-
retarded pregnancies. Obstet Gynecol 1987;69:705–9.
(Level II-2)
24. Alfirevic Z, Neilson JP. Doppler ultrasonography in high-
risk pregnancies: systematic review with meta-analysis.
Am J Obstet Gynecol 1995;172:1379–87. (Meta-analysis)
25. Menticoglou SM, Manning FA, Morrison I, Harman CR.
Must macrosomic fetuses be delivered by a cesarean sec-
tion? A review of outcome for 780 babies greater than or
equal to 4500 g. Aust N Z J Obstet Gynaecol 1992;32:
100–3. (Level II-2)
26. Lipscomb KR, Gregory K, Shaw K. The outcome of
macrosomic infants weighing at least 4500 grams: Los
Angeles county + University of Southern California expe-
rience. Obstet Gynecol 1995;85:558–64. (Level II-3)
27. Nesbitt TS, Gilbert WM, Hernchen B. Shoulder dystocia
and associated risk factors with macrosomic infants born
in California. Am J Obstet Gynecol 1998;179:476–80.
(Level II-3)
28. Hadlock FP, Harrist RB, Carpenter RJ, Deter RL, Park SK.
Sonographic estimation of fetal weight. The value of
femur length in addition to head and abdomen measure-
ments. Radiology 1984;150:535–40. (Level II-3)
29. Alsulyman OM, Ouzounian JG, Kjos SL. The accuracy of
intrapartum ultrasonographic fetal weight estimation in
diabetic pregnancies. Am J Obstet Gynecol 1997;177:
503–6. (Level II-2)
30. Smith GC, Smith MF, McNay MG, Fleming JE. The rela-
tion between fetal abdominal circumference and birth-
weight: findings in 3512 pregnancies. Br J Obstet
Gynaecol 1997;104:186–90. (Level II-3)
31. O’Reilly-Green CP, Divon MY. Receiver operating char-
acteristic curves of sonographic estimated fetal weight for
prediction of macrosomia in prolonged pregnancies.
Ultrasound Obstet Gynecol 1997;9:403–8. (Level II-3)
32. Chauhan SP, Lutton PM, Bailey KJ, Guerrieri JP, Morrison
JC. Intrapartum clinical, sonographic, and parous patients
estimates of newborn birthweight. Obstet Gynecol 1992;
79:956–8. (Level II-3)
33. Raman S, Urquhart R, Yusof M. Clinical versus ultrasound
estimation of fetal weight. Aust N Z J Obstet Gynaecol
1992;32:196–9. (Level II-3)
34. American College of Obstetricians and Gynecologists.
Fetal macrosomia. ACOG Practice Bulletin 22. Washington,
DC: ACOG; 2000. (Level III)
1458 ACOG Practice Bulletin No. 58 Ultrasonography in Pregnancy
The MEDLINE database, the Cochrane Library, and
ACOG’s own internal resources and documents were used
to conduct a literature search to locate relevant articles pub-
lished between January 1985 and September 2004. The
search was restricted to articles published in the English
language. Priority was given to articles reporting results of
original research, although review articles and commentar-
ies also were consulted. Abstracts of research presented at
symposia and scientific conferences were not considered
adequate for inclusion in this document. Guidelines pub-
lished by organizations or institutions such as the National
Institutes of Health and the American College of Obstetri-
cians and Gynecologists were reviewed, and additional
studies were located by reviewing bibliographies of identi-
fied articles. When reliable research was not available,
expert opinions from obstetrician–gynecologists were used.
Studies were reviewed and evaluated for quality according
to the method outlined by the U.S. Preventive Services Task
Force:
I Evidence obtained from at least 1 properly designed
randomized controlled trial.
II-1 Evidence obtained from well-designed controlled
trials without randomization.
II-2 Evidence obtained from well-designed cohort or
case–control analytic studies, preferably from more
than 1 center or research group.
II-3 Evidence obtained from multiple time series with or
without the intervention. Dramatic results in uncon-
trolled experiments also could be regarded as this
type of evidence.
III Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert
committees.
Based on the highest level of evidence found in the data,
recommendations are provided and graded according to the
following categories:
Level A—Recommendations are based on good and consis-
tent scientific evidence.
Level B—Recommendations are based on limited or incon-
sistent scientific evidence.
Level C—Recommendations are based primarily on con-
sensus and expert opinion.
Copyright © December 2004 by the American College of Obstetricians
and Gynecologists. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical, photocopying, recording, or
otherwise, without prior written permission from the publisher.
Requests for authorization to make photocopies should be directed to
Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA
01923, (978) 750-8400.
The American College of Obstetricians and Gynecologists
409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920
12345/87654
Ultrasonography in pregnancy. ACOG Practice Bulletin No. 58.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2004;104:1449–58.
OBSTETRICS & GYNECOLOGY
 ACOG
EDUCATIONAL and
PRACTICE BULLETINS
LIST OF TITLES — DECEMBER 2004
Educational and Practice Bulletins provide obstetricians and gynecologists with
The following titles have been
current information on established techniques and clinical management guide-
withdrawn from circulation:
lines. ACOG continuously surveys the field for advances to be incorporated in
Educational Bulletin these series and monitors existing bulletins to ensure they are current. Individual
253 Special Problems of bulletins are withdrawn from and added to the series on a continuing basis.
Multiple Gestation
(Replaced by Practice
Bulletin No. 56) General
Practice Patterns 255 Psychosocial Risk Factors: Perinatal Screening and Intervention
5 Routine Ultrasound in Low- (November 1999, Obstet Gynecol Vol. 94, No. 5)
Risk Pregnancy (Replaced
258 Breastfeeding: Maternal and Infant Aspects (July 2000, Obstet Gynecol
by Practice Bulletin No. 58)
Vol. 96, No. 1)
6 Management of Postterm
Pregnancy (Replaced by
Practice Bulletin No. 55) Obstetrics
▼ ▼ ▼ ▼ ▼ ▼ ▼ ▼ ▼ ▼ ▼

1 Premature Rupture of Membranes (June 1998, Obstet Gynecol Vol. 91, No. 6)
4 Prevention of Rh D Alloimmunization (May 1999, Obstet Gynecol Vol. 93, No. 5)
Current Bulletins 6 Thrombocytopenia in Pregnancy (September 1999, Obstet Gynecol Vol. 94, No. 3)
8 Management of Herpes in Pregnancy (October 1999, Obstet Gynecol Vol. 94, No. 4)
1 3 4 6 7 8 9
▲
▲

▲
▲

9 Antepartum Fetal Surveillance (October 1999, Obstet Gynecol Vol. 94, No. 4)
10 11 12 13 14 15 16
▲
▲

▲
▲

▲
▲

17 18 19 20 21 22 23 10 Induction of Labor (November 1999, Obstet Gynecol Vol. 94, No. 5)

▲

▲
▲

▲
▲
▲

24 25 26 27 28 29 30 12 Intrauterine Growth Restriction (January 2000, Obstet Gynecol Vol. 95, No. 1)
▲
▲

31 33 34 35 36 37 38
▲
▲

39 40 41 42 43 44 45 13 External Cephalic Version (February 2000, Obstet Gynecol Vol. 95, No. 2)
▲

46 47 48 49 50 51 52 17 Operative Vaginal Delivery (June 2000, Obstet Gynecol Vol. 95, No. 6)
▲

53 54 55 56 57 58 207
▲

▲
▲

227 230 236 244 248 251 255 19 Thromboembolism in Pregnancy (August 2000, Obstet Gynecol Vol. 96, No. 2)
258 260 20 Perinatal Viral and Parasitic Infections (September 2000, Obstet Gynecol
Vol. 96, No. 3)
▼ ▼

22 Fetal Macrosomia (November 2000, Obstet Gynecol Vol. 96, No. 5)

24 Management of Recurrent Early Pregnancy Loss (February 2001, Obstet Gynecol
Vol. 97, No. 2)
▼

27 Prenatal Diagnosis of Fetal Chromosomal Abnormalities (May 2001, Obstet

Gynecol Vol. 97, No. 5)
29 Chronic Hypertension in Pregnancy (Obstet Gynecol 2001;98:177–185)
▼ ▼ ▼ ▼

30 Gestational Diabetes (Obstet Gynecol 2001;98:525–538)

31 Assessment of Risk Factors for Preterm Birth (Obstet Gynecol 2001;98:709–716)
33 Diagnosis and Management of Preeclampsia and Eclampsia (Obstet Gynecol
2002;99:159–167)
36 Obstetric Analgesia and Anesthesia (Obstet Gynecol 2002;100:177–191)
▼ ▼

37 Thyroid Disease in Pregnancy (Obstet Gynecol 2002;100:387–396)

VOL. 104, NO. 6, DECEMBER 2004 ACOG Educational and Practice Bulletins List of Titles 1459
Obstetrics (continued)

▼
11 Medical Management of Endometriosis (December
1999, Obstet Gynecol Vol. 94, No. 6)
38 Perinatal Care at the Threshold of Viability (Obstet
▼

▼
14 Management of Anovulatory Bleeding (March 2000,
Gynecol 2002;100:617–24)
Obstet Gynecol Vol. 95, No. 3)
40 Shoulder Dystocia (Obstet Gynecol 2002;100:1045–50)
▼ ▼

15 Premenstrual Syndrome (April 2000, Obstet Gynecol

▼
43 Management of Preterm Labor (Obstet Gynecol Vol. 95, No. 4)
2003;101:1039–47)
16 Surgical Alternatives to Hysterectomy in the

▼
44 Neural Tube Defects (Obstet Gynecol 2003;102:203–13)
▼ ▼

Management of Leiomyomas (May 2000, Obstet

47 Prophylactic Antibiotics in Labor and Delivery (Obstet Gynecol Vol. 95, No. 5)
Gynecol 2003;102:875–82)
18 The Use of Hormonal Contraception in Women with

▼
48 Cervical Insufficiency (Obstet Gynecol 2003;102:1091–9)
▼ ▼

Coexisting Medical Conditions (July 2000, Obstet

49 Dystocia and Augmentation of Labor (Obstet Gynecol Gynecol Vol. 96, No. 1)
2003;102:1445–54) 21 Prevention of Deep Vein Thrombosis and Pulmonary

▼
52 Nausea and Vomiting of Pregnancy (Obstet Gynecol Embolism (October 2000, Obstet Gynecol Vol. 96,
▼

2004;103:803–15) No. 4)
54 Vaginal Birth After Previous Cesarean Delivery (Obstet
▼

23 Antibiotic Prophylaxis for Gynecologic Procedures

▼
Gynecol 2004;104:203–12) (January 2001, Obstet Gynecol Vol. 97, No. 1)
▼

*55 Management of Postterm Pregnancy (Obstet Gynecol

▼
25 Emergency Oral Contraception (March 2001, Obstet
2004;104:639–46) Gynecol Vol. 97, No. 3)
*56 Multiple Gestation: Complicated Twin, Triplet, and
▼

▼
26 Medical Management of Abortion (April 2001, Obstet
High-Order Multifetal Pregnancy (Obstet Gynecol Gynecol Vol. 97, No. 4)
2004;104:869–83) ▼
28 Use of Botanicals for Management of Menopausal
▼

*58 Ultrasonography in Pregnancy (Obstet Gynecol Symptoms (June 2001, Obstet Gynecol Vol. 97, No. 6)
2004;104:1449–58)
34 Management of Infertility Caused by Ovulatory
▼

207 Fetal Heart Rate Patterns: Monitoring, Interpretation, and Dysfunction (Obstet Gynecol 2002;99:347–358)
Management (July 1995)
▼

35 Diagnosis and Treatment of Cervical Carcinomas

227 Management of Isoimmunization in Pregnancy (August (Obstet Gynecol 2002;99:855–867)
1996)
▼

39 Selective Estrogen Receptor Modulators (Obstet

230 Assessment of Fetal Lung Maturity (November 1996) Gynecol 2002;100:835–44)
236 Teratology (April 1997)
▼

41 Polycystic Ovary Syndrome (Obstet Gynecol

244 Antiphospholipid Syndrome (February 1998) 2002;100:1389–402)
▼

248 Viral Hepatitis in Pregnancy (July 1998, Obstet Gynecol 42 Breast Cancer Screening (Obstet Gynecol
Vol. 92, No. 1) 2003;101:821–32)
45 Cervical Cytology Screening (Obstet Gynecol
▼

251 Obstetric Aspects of Trauma Management (September

1998, Obstet Gynecol Vol. 92, No. 3) 2003;102:417–27)
260 Smoking Cessation During Pregnancy (September 46 Benefits and Risks of Sterilization (Obstet Gynecol
▼

2000, Obstet Gynecol Vol. 96, No. 3) 2003;102:647–58)

▼ ▼

50 Osteoporosis (Obstet Gynecol 2004;103:203–16)

Gynecology 51 Chronic Pelvic Pain (Obstet Gynecol
2004;103:589–605)
▼

3 Medical Management of Tubal Pregnancy (December

▼

53 Diagnosis and Treatment of Gestational Trophoblastic

1998, Obstet Gynecol Vol. 92, No. 6) Disease (Obstet Gynecol 2004;103:1365–77)
7 Prophylactic Oophorectomy (September 1999, Obstet
▼
▼

*57 Gynecologic Herpes Simplex Virus Infections (Obstet

Gynecol Vol. 94, No. 3) Gynecol 2004;104:1111–7)

The following Educational and Technical Bulletins will be replaced by Special Issues in Women’s Health:
194 Substance Abuse 252 Adolescent Victims of Sexual Assault
201 Pediatric Gynecologic Disorders 257 Domestic Violence
240 Smoking and Women’s Health 259 Adult Manifestations of Childhood
242 Sexual Assault Sexual Abuse

Practice and Educational Bulletins are available on a subscription basis, and complete sets may be purchased. For
ordering information, contact the ACOG Distribution Center at 800-762-2264, or order online at sales.acog.org.

*Title issued since publication of last listing

▼

Practice Bulletin AT005

1460 ACOG Educational and Practice Bulletins List of Titles OBSTETRICS & GYNECOLOGY
 ACOG Committee Opinions
List of Titles
December 2004
Committee Opinions are intended to provide timely information on controversial issues, ethical concerns, and emerg-
ing approaches to clinical management. They represent the considered views of the sponsoring committee based on
interpretation of published data in peer-reviewed journals. Committee Opinions are reviewed periodically for contin-
ued relevance or needed update. Note: Because individual Committee Opinions are withdrawn from and added to the
series on a continuing basis, the titles listed in this index may not be identical to those contained in complete sets.
Also listed are Technology Assessments, which provide an overview of technology in obstetrics and gynecology.
The following Committee Opinions have been withdrawn from circulation:
158 Guidelines for Diagnostic Imaging During Pregnancy (Replaced by Committee Opinion No. 299)
180 New Ultrasound Output Display Standard (Replaced by Practice Bulletin No. 58)
197 Inappropriate Use of the Terms Fetal Distress and Birth Asphyxia (Replaced by Committee Opinion No. 303)
235 Hormone Replacement Therapy in Women Treated for Endometrial Cancer
237 Informed Refusal (Replaced by Committee Opinion No. 306)

Publication Reaffirmed
Number Title Date Date

Committee on Adolescent Health Care

274 Nonsurgical Diagnosis and Management of Vaginal Agenesis
(Obstet Gynecol 2002;100:213–216) July 2002
*300 Cervical Cancer Screening in Adolescents
(Obstet Gynecol 2004;104:885–9) October 2004
*301 Sexually Transmitted Diseases in Adolescents
(Obstet Gynecol 2004;104:891–8) October 2004
*302 Guidelines for Adolescent Health Research
(Obstet Gynecol 2004;104:899–902) October 2004
Committee on Coding and Nomenclature
205 Tubal Ligation with Cesarean Delivery (Obstet Gynecol Vol. 92, No. 2) August 1998
249 Coding Responsibility (Obstet Gynecol Vol. 97, No. 1) January 2001
250 Inappropriate Reimbursement Practices by Third-Party Payers
(Obstet Gynecol Vol. 97, No. 1) January 2001

Committee on Ethics
†
294 At-Risk Drinking and Illicit Drug Use: Ethical Issues in Obstetric
and Gynecologic Practice (Obstet Gynecol 2004;103:1021–31) May 2004
†
297 Nonmedical Use of Obstetric Ultrasonography
(Obstet Gynecol 2004;104:423–4) August 2004

Committee on Genetics (published as Genetics in Obstetrics and Gynecology)

161 Fragile X Syndrome October 1995 2000
162 Screening for Tay–Sachs Disease November 1995 2003
183 Routine Storage of Umbilical Cord Blood for Potential Future
Transplantation (Joint with Committee on Obstetric Practice) April 1997 2004
189 Advanced Paternal Age: Risks to the Fetus October 1997 2003
212 Screening for Canavan Disease (Obstet Gynecol Vol. 92, No. 5) November 1998 2004
230 Maternal Phenylketonuria (Obstet Gynecol Vol. 95, No. 1) January 2000 2004
238 Genetic Screening for Hemoglobinopathies (Obstet Gynecol Vol. 96, No. 1) July 2000 2004
257 Genetic Evaluation of Stillbirths and Neonatal Deaths
(Obstet Gynecol Vol. 97, No. 5) May 2001
‡
287 Newborn Screening (Obstet Gynecol 2003;102:887–9) October 2003
‡
296 First-Trimester Screening for Fetal Aneuploidy (Joint with Committee
on Obstetric Practice) (Obstet Gynecol 2004;104:215–7) July 2004

VOL. 104, NO. 6, DECEMBER 2004 ACOG Committee Opinions List of Titles 1461
 Publication Reaffirmed
Number Title Date Date

Committee on Genetics (continued)

‡
298 Prenatal and Preconceptional Carrier Screening for Genetic
Diseases in Individuals of Eastern European Jewish Descent
(Obstet Gynecol 2004;104:425–8) August 2004
1 Genetics and Molecular Diagnostic Testing (Obstet Gynecol 2002;100:193–211) July 2002
Committee on Gynecologic Practice
164 Incidental Appendectomy December 1995 2000
186 Role of the Obstetrician–Gynecologist in the Diagnosis
and Treatment of Breast Disease September 1997 2003
191 Length of Hospital Stay for Gynecologic Procedures October 1997 2003
203 Hepatitis Virus Infections in Obstetrician–Gynecologists
(Obstet Gynecol Vol. 92, No. 1) July 1998 2001
232 Tamoxifen and Endometrial Cancer (Obstet Gynecol Vol. 95, No. 4) April 2000 2001
240 Statement on Surgical Assistants (Obstet Gynecol Vol. 96, No. 2)
(Joint with Committee on Obstetric Practice) August 2000 2003
243 Performance and Interpretation of Imaging Studies
by Obstetrician–Gynecologists (Obstet Gynecol Vol. 96, No. 5) November 2000 2003
245 Mifepristone for Medical Pregnancy Termination (Obstet Gynecol Vol. 96, No. 6) December 2000 2003
253 Nongynecologic Procedures (Obstet Gynecol Vol. 97, No. 3) March 2001
263 Von Willebrand’s Disease in Gynecologic Practice
(Obstet Gynecol 2001;98:1185–1186) December 2001
272 Follow-up of Abnormal Screening Mammography
(Obstet Gynecol 2002;99:869) May 2002
278 Avoiding Inappropriate Clinical Decisions Based on False-Positive Human
Chorionic Gonadotropin Test Results (Obstet Gynecol 2002;100:1057–9) November 2002
280 The Role of the Generalist Obstetrician–Gynecologist in the Early
Detection of Ovarian Cancer (Joint with Society of Gynecologic Oncologists)
(Obstet Gynecol 2002;100:1413–6) December 2002
285 Induced Abortion and Breast Cancer Risk (Obstet Gynecol 2003;102:433–5) August 2003
288 Professional Liability and Gynecology-Only Practice
(Joint with Committees on Obstetric Practice and Professional Liability)
(Obstet Gynecol 2003;102:891) October 2003
292 Primary and Preventive Care: Periodic Assessments
(Obstet Gynecol 2003;102:1117–24) November 2003
293 Uterine Artery Embolization (Obstet Gynecol 2004;103:403–4) February 2004
2 Cervical Cytology Screening (Obstet Gynecol 2002;100:1423–7) December 2002
3 Saline Infusion Sonohysterography (Obstet Gynecol 2003;102:659–62) September 2003
Committee on Health Care for Underserved Women
*307 Partner Consent for Participation in Women’s Reproductive Health Research
(Obstet Gynecol 2004;104:1467–9) December 2004
*308 The Uninsured (Obstet Gynecol 2004;104:1471–4) December 2004
Committee on Obstetric Practice
125 Placental Pathology July 1993 2003
174 Use and Abuse of the Apgar Score (Joint with AAP Committee
on Fetus and Newborn) July 1996 1999
183 Routine Storage of Umbilical Cord Blood for Potential
Future Transplantation (Joint with Committee on Genetics) April 1997 2004
228 Induction of Labor with Misoprostol (Obstet Gynecol Vol. 94, No. 5) November 1999 2004
234 Scheduled Cesarean Delivery and the Prevention of Vertical Transmission
of HIV Infection (Obstet Gynecol Vol. 95, No. 5) May 2000 2003
240 Statement on Surgical Assistants (Joint with Committee
on Gynecologic Practice) (Obstet Gynecol Vol. 96, No. 2) August 2000 2003
248 Response to Searle’s Drug Warning on Misoprostol
(Obstet Gynecol Vol. 96, No. 6) December 2000 2003
256 Optimal Goals for Anesthesia Care in Obstetrics (Joint with American Society
of Anesthesiologists) (Obstet Gynecol Vol. 97, No. 5) May 2001 2004
258 Fetal Pulse Oximetry (Obstet Gynecol 2001;98:523–524) September 2001

1462 ACOG Committee Opinions List of Titles OBSTETRICS & GYNECOLOGY

 Publication Reaffirmed
Number Title Date Date

Committee on Obstetric Practice (continued)

260 Circumcision (Obstet Gynecol 2001;98:707–708) October 2001
264 Air Travel During Pregnancy (Obstet Gynecol 2001;98:1187–1188) December 2001 2004
265 Mode of Term Singleton Breech Delivery
(Obstet Gynecol 2001;98:1189–1190) December 2001 2004
266 Placenta Accreta (Obstet Gynecol 2002;99:169–170) January 2002
267 Exercise During Pregnancy and the Postpartum Period
(Obstet Gynecol 2002;99:171–173) January 2002
268 Management of Asymptomatic Pregnant or Lactating Women
Exposed to Anthrax (Obstet Gynecol 2002;99:366–368) February 2002
269 Analgesia and Cesarean Delivery Rates (Obstet Gynecol 2002;99:369–370) February 2002
271 Induction of Labor for Vaginal Birth After Cesarean Delivery
(Obstet Gynecol 2002;99:679–680) April 2002
273 Antenatal Corticosteroid Therapy for Fetal Maturation
(Obstet Gynecol 2002;99:871–873) May 2002
275 Obstetric Management of Patients with Spinal Cord Injuries
(Obstet Gynecol 2002;100:625–7) September 2002
276 Safety of Lovenox in Pregnancy (Obstet Gynecol 2002;100:845–6) October 2002
279 Prevention of Early-Onset Group B Streptococcal Disease in Newborns
(Obstet Gynecol 2002;100:1405–12) December 2002
281 Rubella Vaccination (Obstet Gynecol 2002;100:1417) December 2002
282 Immunization During Pregnancy (Obstet Gynecol 2003;101:207–12) January 2003
283 New U.S. Food and Drug Administration Labeling on Cytotec (Misoprostol)
Use and Pregnancy (Obstet Gynecol 2003;101:1049–50) May 2003
284 Nonobstetric Surgery in Pregnancy (Obstet Gynecol 2003;102:431) August 2003
288 Professional Liability and Gynecology-Only Practice
(Joint with Committees on Gynecologic Practice and Professional Liability)
(Obstet Gynecol 2003;102:891) October 2003
291 Use of Progesterone to Reduce Preterm Birth (Obstet Gynecol 2003;102:1115–6) November 2003
295 Pain Relief During Labor (Joint with American Society
of Anesthesiologists) (Obstet Gynecol 2004;104:213) July 2004
296 First-Trimester Screening for Fetal Aneuploidy (Joint with Committee
on Genetics) (Obstet Gynecol 2004;104:215–7) July 2004
*299 Guidelines for Diagnostic Imaging During Pregnancy
(Obstet Gynecol 2004;104:647–51) September 2004
*303 Inappropriate Use of the Terms Fetal Distress and Birth Asphyxia
(Obstet Gynecol 2004;104:903–4) October 2004
*304 Prenatal and Perinatal Human Immunodeficiency Virus Testing:
Expanded Recommendations (Obstet Gynecol 2004;104:1119–24) November 2004
*305 Influenza Vaccination and Treatment During Pregnancy
(Obstet Gynecol 2004;104:1125–6) November 2004
Committee on Primary Care
227 Complementary and Alternative Medicine (Obstet Gynecol Vol. 94, No. 5) November 1999 2001
Committee on Professional Liability
236 Coping with the Stress of Malpractice Litigation
(Obstet Gynecol Vol. 95, No. 6) June 2000
288 Professional Liability and Gynecology-Only Practice
(Joint with Committees on Obstetric Practice and Gynecologic Practice)
(Obstet Gynecol 2003;102:891) October 2003
*306 Informed Refusal (Obstet Gynecol 2004;104:1465–6) December 2004
Committee on Quality Improvement and Patient Safety
286 Patient Safety in Obstetrics and Gynecology (Obstet Gynecol 2003;102:883–5) October 2003

VOL. 104, NO. 6, DECEMBER 2004 ACOG Committee Opinions List of Titles 1463
 The following Committee Opinions will be replaced by Special Issues in Women’s Health:
200 Mandatory Reporting of Domestic Violence
201 Cultural Competency in Health Care
202 Access to Health Care for Women with Physical Disabilities

Current Committee Opinions and Technology Assessments

1 2 3 125 161 162 164 174 183 186 189 191 203 205 212 227 228 230 232 234
236 238 240 243 245 248 249 250 253 256 257 258 260 263 264 265 266 267 268 269
271 272 273 274 275 276 278 279 280 281 282 283 284 285 286 287 288 291 292 293
294 295 296 297 298 299 300 301 302 303 304 305 306 307 308

Committee Opinions are available on a subscription basis, and complete sets may be purchased. For ordering
information, contact the ACOG Distribution Center at 800-762-2264, or order online at sales.acog.org.
*Title issued since publication of last index
†
Title issued since publication of Ethics in Obstetrics and Gynecology, Second Edition
‡
Title issued since publication of Genetics in Obstetrics and Gynecology AC002
Technology Assessment

1464 ACOG Committee Opinions List of Titles OBSTETRICS & GYNECOLOGY

ACOG
Committee on
Professional Liability
This document provides risk
management information that is
current as of the date issued and
is subject to change. This docu-
ment does not define a standard
of care nor should it be inter-
preted as legal advice.
Copyright © December 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
12345/87654
Informed refusal. ACOG Committee
Opinion No. 306. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:1465–6.
VOL. 104, NO. 6, DECEMBER 2004
Committee
Opinion
Number 306, December 2004 (Replaces No. 237, June 2000)
Informed Refusal
ABSTRACT: Informed refusal is a fundamental component of the informed
consent process. Informed consent laws have evolved to the “materiality or
patient viewpoint”standard. A physician must disclose to the patient the risks,
benefits, and alternatives that a reasonable person in the patient’s position
would want to know to make an informed decision. Throughout this process,
the patient’s autonomy, level of health literacy, and cultural background
should be respected. The subsequent election by the patient to forgo an inter-
vention that has been recommended by the physician constitutes informed
refusal. Documentation of the informed refusal process is essential. It should
include a notation that the need for the intervention, as well as risks, benefits,
and alternatives to the intervention, and possible consequences of refusal,
have been explained. The patient’s reason for refusal also should be docu-
mented.
Informed refusal is inextricably intertwined with the process of informed
consent. After addressing the risks, benefits, and alternatives of a proposed
medical treatment, surgical procedure, or diagnostic test, an explanation of
the risks of refusing or declining the proposed intervention also must be
given; this should be considered a fourth element of the consent process. Just
as a patient has the right to consent to treatment, she may choose to refuse
treatment. Patients are entitled to participate with their physicians in a process
of shared decision making (1).
Informed consent laws have evolved from the relatively paternalistic
“professional or reasonable physician” standard to the “materiality or patient
viewpoint” standard. In the professional or reasonable physician standard, a
physician must disclose to a patient the risks and benefits that are customar-
ily disclosed by the medical community for that medical treatment, surgical
procedure, or diagnostic test. In the materiality or patient viewpoint standard,
a physician must disclose to the patient the risks, benefits, and alternatives
that a reasonable person in the patient’s position would want to know to make
an informed decision. In making such disclosure, a physician also must make
allowance for the patient’s level of health literacy and cultural background. It
often is helpful, for example, to ask the patient to explain in her own words
her understanding of the essential elements of this patient–physician
exchange of information. As is frequently emphasized, informed consent is a
process and not a mere document.
ACOG Committee Opinion No. 306 Informed Refusal 1465
 Once a patient has been informed of the materi-
al risks, benefits, and alternatives, as well as the
option to refuse, the patient has the right to exercise
complete autonomy in deciding whether to undergo
the recommended medical treatment, surgical proce-
dure, or diagnostic test; to choose among a variety of
treatments, procedures, or tests; or to refuse to under-
go these treatments, procedures, or tests. The elec-
tion by the patient to forgo an intervention that has
been recommended by the physician constitutes
informed refusal.
In the past, documentation of informed refusal
has not been an important element; however, it has
become important in the present health care environ-
ment. Managed care and increased patient autonomy
are 2 factors that warrant a reexamination of the need
for documentation of informed refusal. The wide-
spread implementation of managed care and utiliza-
tion review sometimes has created a conflict between
cost containment, sometimes camouflaged as “med-
ical necessity,” and best medical practices or even
standard medical practices. It is not uncommon for a
physician to recommend a medical treatment, surgi-
cal procedure, or diagnostic test that will not be paid
for by a third-party insurance carrier. Legal prece-
dents have established that an attending physician
should act as a patient advocate in such coverage dis-
putes and attempt to convince the managed care
organization that coverage is medically indicated.
Despite such advocacy, however, there will be situa-
tions in which physicians will not prevail on behalf
of their patients. In such circumstances, a physician
should discuss with the patient whether she wishes to
accept personal financial responsibility for the med-
ical treatment, surgical procedure, or diagnostic test,
or whether to seek alternative funding. If the patient
refuses to undergo the medical treatment, surgical
procedure, or diagnostic test for economic or other
reasons, the physician should document the informed
refusal in the patient’s medical record. In some situa-
tions the physician might want to obtain a written
1466 ACOG Committee Opinion No. 306 Informed Refusal
statement from the patient, acknowledging that the
risk of refusal was fully explained.
The increased emphasis on patient autonomy in
medical decision making has given rise to other cir-
cumstances in which documentation of an informed
refusal is appropriate. Despite a physician’s medical
advice or recommendation, a patient who is informed
of the material risks, benefits, and alternatives of par-
ticular interventions may elect to forgo them because
of cultural or religious beliefs, personal preference, or
comfort. This decision should be respected. (Patient
choice in the maternal–fetal relationship may require
special considerations. Guidance for these issues can
be found in another ACOG publication [2].) Alter-
natively, the patient may weigh the risks and benefits
differently than the physician or, simply, the patient
may not understand the risk of refusal.
Whenever a patient refuses a medical treatment,
surgical procedure, or diagnostic test, the physician
should document the informed refusal in the
patient’s medical record and include the following
information:
• The patient’s refusal to consent to a medical
treatment, surgical procedure, or diagnostic test
• Documentation that the need for the treatment,
procedure, or test has been explained
• The reasons stated by the patient for such refusal
• A statement that the consequences of the
refusal, including possible jeopardy to health or
life, have been described to the patient
References
1. American College of Obstetricians and Gynecologists.
Informed consent. In: Ethics in obstetrics and gynecology.
2nd ed. Washington, DC: ACOG; 2004. p. 9–17.
2. American College of Obstetricians and Gynecologists.
Patient choice in the maternal–fetal relationship. In:
Ethics in obstetrics and gynecology. 2nd ed. Washington,
DC: ACOG; 2004. p. 34–6.
OBSTETRICS & GYNECOLOGY
 ACOG
Committee on
Health Care for
Underserved Women
The information should not be
construed as dictating an exclu-
sive course of treatment or proce-
dure to be followed.
The Committee wishes to thank
Kurt Barnhart, MD, MSCE;
Jeffrey Ecker, MD; and Carol
Tauer, PhD; for their assistance in
the development of this document.
Copyright © December 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or other-
wise, without prior written per-
mission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
12345/87654
Partner consent for participation in
women’s reproductive health research.
ACOG Committee Opinion No. 307.
American College of Obstetricians and
Gynecologists. Obstet Gynecol 2004;
104:1467–9.
VOL. 104, NO. 6, DECEMBER 2004
Committee
Opinion
Number 307, December 2004
Partner Consent for Participation in
Women’s Reproductive Health
Research
ABSTRACT: Recent advances in reproductive medicine include treatment of
subfertility as well as investigation of agents that may serve as both contra-
ceptives and potential prophylaxis against sexually transmitted diseases,
including potential protection from human immunodeficiency virus (HIV).
Although there is no doubt regarding the need for informed consent by women
participating in trials evaluating the safety and effectiveness of these novel
agents and treatments, there has been some debate regarding the necessity
and propriety of requiring consent from the partners of women involved in
certain types of clinical trials involving reproductive health. Issues of partner
consent are unique to research surrounding women’s reproductive health as
opposed to research pertaining to women’s health, in general. This is due, in
part, to a valid concern about a potential effect of the research on the part-
ner. There are, therefore, legitimate reasons to obtain partner consent for a
woman’s participation in a clinical trial. In the absence of such reason, part-
ner consent should not be mandated.
Background
A large number of clinical trials are currently being conducted in nearly every
therapeutic area, including women’s health. Women may be motivated to par-
ticipate in clinical trials by altruism to further the care of women, by the abil-
ity to receive novel and state-of-the-art medical care, or by the benefits of
highly supervised medical monitoring of treatment. Often women without
health insurance choose to participate in these trials because such trials may
provide enhanced access to care, the care provided is often rendered without
cost, and there is reimbursement for time and travel. The American College
of Obstetricians and Gynecologists supports the development of new devices
and medications to advance women’s health and reproductive options. The
American College of Obstetricians and Gynecologists also endorses the high-
est ethical and moral conduct of clinical research. All women, regardless of
socioeconomic status and race, should have access to enrollment in clinical
trials. The decision to enter a clinical trial should be autonomous, without
ACOG Committee Opinion No. 307 Partner Consent for Participation in Women's 1467
Reproductive Health Research
coercion, and after informed consent. Informed con-
sent is the ability to understand the risks and benefits
of one’s participation in a research activity and to
authorize one’s participation in this activity freely (1).
A research subject is defined as “An individual
who participates in a clinical trial, either as a recipi-
ent of the investigational product(s) or as a control.”
(2). In research on women’s reproductive health,
sometimes both the woman and her partner will be
the subjects. For example, in a study designed to
identify any risk or harm to a partner of a new con-
traceptive method, both the woman and her partner
may be research subjects. If a partner is a subject in
the research, informed consent for both participants
is required. This Committee Opinion primarily
addresses the need for partner consent in research
for which the woman, and not a partner, is the
research subject. The respect for the autonomy of
research subjects to consent to participation is one of
the pillars of The Belmont Report, promulgated by
The National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research in 1979 (3). The decision to reproduce or
use contraceptives should remain autonomous for a
woman even when enrolled in a clinical trial.
It also is important to note that the discussion
and recommendations that follow do not pertain to
research involving pregnant women. There are spe-
cific regulations that apply to federally funded
research involving this population (4).
Partner Consent Requirement
Inconsistencies
Recent advances in reproductive medicine include
treatment of subfertility as well as investigation of
agents that may serve as both contraceptives and
potential prophylaxis against sexually transmitted
diseases, including potential protection from human
immunodeficiency virus (HIV). Although there is no
doubt regarding the need for informed consent by
women participating in trials evaluating the safety
and effectiveness of these novel agents and treat-
ments, there has been some debate regarding the
necessity and propriety of requiring consent from the
partners of women involved in certain types of clinical
trials involving reproductive health. Some local insti-
tutional review boards (IRB) have requested consent
of a woman’s partner and at other times a trial spon-
sor or an individual investigator has made the deci-
1468 ACOG Committee Opinion No. 307 Partner Consent for Participation in Women's
Reproductive Health Research
sion unilaterally. Because of the lack of guidance on
this issue, there is great inconsistency regarding
requirements for partner consent and the manner in
which partner consent is obtained (see box
“Methods of Obtaining Partner Consent”).
When Is Partner Consent Needed?
Issues of partner consent are unique to research sur-
rounding women’s reproductive health as opposed
to research pertaining to women’s health, in general.
This is partly due to a valid concern about a poten-
tial impact of the research on the partner. Therefore,
there are legitimate reasons to obtain partner consent
for a woman’s participation in a clinical trial. In the
absence of such reason, partner consent should not
be mandated. Partner consent should be obtained if:
• A sexual partner is a subject in the same clinical
trial as the woman.
• A partner will be exposed to a novel agent and
there is a potential for more than minimal risks*
of exposure to the investigational agent.
• Data will be collected regarding a partner’s
acceptance of the investigational agent, or the
impact of partner’s acceptance of the agent on
the female participant.
• Inclusion or exclusion criteria directly relate to
a partner, for example, if testing of a partner is
required for a woman to enroll in the trial (eg,
semen analysis or testing for a sexually trans-
mitted disease).
If, after careful consideration, it is determined that
none of the previous conditions apply, partner con-
sent is not warranted because it should not need-
lessly:
• Impose a barrier to participation for a woman
• Interfere with a woman’s choice of reproduc-
tive options
• Interfere with a woman’s right to make inde-
pendent decisions about her reproductive health
care due to an IRB’s or regulatory agency’s
paternalistic reasons for partner consent
*According to applicable federal regulations, “Minimal risk
means that the probability and magnitude of harm or discom-
fort anticipated in the research are not greater in and of them-
selves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examina-
tions or tests.” (45 C.F.R §46.102[I]).
OBSTETRICS & GYNECOLOGY

Methods of Obtaining Partner Consent
Several methods exist that may be used to obtain partner
consent regarding a woman’s participation in a clinical
trial. The suitability of these methods depends on the
particular research study. Some ways of obtaining part-
ner consent include:
• Having a partner attend the screening visit and sign
the consent at that time
• Giving a copy of the consent to the participant and
having a partner come in for a separate visit to con-
sent
• Mailing the consent and having it mailed back
• Performing the informed consent process over the
telephone
• Obtaining a single informed consent that is signed by
the woman and partner
Recommendations
Recognizing the complexities of the conduct and
consent requirements for trials in women’s repro-
ductive health, the following recommendations are
made:
• The partner consent requirements of each clini-
cal trial need to be individually evaluated and
based on the best available scientific and med-
ical evidence and ethical principles.
• When partner consent is required, efforts
should be undertaken to decrease the likelihood
that receipt of such consent will be a barrier for
participation of a woman interested in enrolling
in such a trial. The addition of consent adds
complexity to all trials, often resulting in addi-
tional visits for the participant and partner.
This can result in fewer women enrolling and a
decrease in compliance.
• Whenever possible, the choice of a woman to
enroll in a clinical trial regarding her reproduc-
tive function and health should be hers alone
when it does not also include a partner as a
research subject. In these instances, the woman,
not the IRB or the researcher(s), considering
the research study should determine the extent
to which a partner is to be involved in the
process of informed consent and the decision to
participate. For example:
—In the case of the study of a microbicide or
barrier contraception efficacy, the risk to a
VOL. 104, NO. 6, DECEMBER 2004 ACOG Committee Opinion No. 307 Partner Consent for Participation in Women's
partner is likely negligible (compared with
the female partner) because of minimal con-
tact time. If potential irritation to a male part-
ner is suspected, it should be ruled out in the
early stages of clinical investigation.
—In contraceptive research where the partici-
pant may face an unintended pregnancy, a
partner may be a potential father with the
resultant legal and moral responsibilities for
the child. However, the principle of autono-
my, allowing a woman to make a choice to
enter a trial regarding her reproductive
rights, should take precedence (5). The
American College of Obstetricians and
Gynecologists does not support recognition
of distinct paternal rights before the birth of a
child (6).
• Regardless of the requirement for partner con-
sent, communication with a partner about
reproductive health and contraception use
should be encouraged.
References
1. American College of Obstetricians and Gynecologists.
Informed consent. In: Ethics in obstetrics and gynecology.
2nd ed. Washington (DC): ACOG; 2004. p. 9–17.
2. International Conference On Harmonisation. Guideline for
good clinical practice. ICH Harmonised Tripartite Guideline
E6. London: ICH; 1997. Available at: http://www.proclinica.fr/
GCPICH.pdf. Retrieved August 26, 2004.
3. The National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. The
Belmont report: ethical principles and guidelines for the
protection of human subjects of research. Washington,
DC: U.S Department of Health and Human Services;
1979. Available at: http://www.hhs.gov/ohrp/humansub
jects/guidance/belmont.htm. Retrieved August 26, 2004.
4. Protection of human subjects. 45 C.F.R §46 (2003). Available
at: http://www.access.gpo.gov/nara/cfr/waisidx_03/45cfr46
_03.html. Retrieved August 27, 2004.
5. Holder AR. Contraceptive research: do sex partners have
rights? IRB 1982;4(2):6–7.
6. American College of Obstetricians and Gynecologists.
Research involving women. In: Ethics in obstetrics and
gynecology. 2nd ed. Washington (DC): ACOG; 2004.
p. 86–91.
1469
Reproductive Health Research