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Original Research ajog.

org

OBSTETRICS

Antenatal corticosteroid timing: accuracy after


the introduction of a rescue course protocol
Neeta K. Makhija, MD; Ashlie A. Tronnes, MD; Benjamin S. Dunlap, BA;
Jay Schulkin, PhD; Sophia M. Lannon, MD, MPH

BACKGROUND: Antenatal corticosteroid administration is a critical P < .01) and delivered at comparable gestational ages (32.7 vs 32.6
fetal intervention, and the use of a rescue protocol is now standard weeks; P .59). Availability of a second course did not increase total
practice. Rescue antenatal corticosteroid may improve overall accuracy of subjects who delivered within any optimal window (26.5% vs 28.5%;
antenatal corticosteroid administration timing, but this observation and its P .41). Frequency of delivery within the initial course optimal window did
effect on the initial course is unknown. not change after the introduction of the rescue course protocol (26.1% vs
OBJECTIVE: We sought to compare the accuracy of antenatal corti- 26.4%; P .92). Similarly, of the 73 subjects who received rescue
costeroid administration before and after the implementation of a rescue antenatal corticosteroid, 24.7% delivered in the optimal window of the
antenatal corticosteroid protocol. second course. Delivery within the optimal window varied by indication for
STUDY DESIGN: We performed a retrospective cohort study of pa- antenatal corticosteroid, with highest accuracy among maternal in-
tients who received a minimum of 1 dose of antenatal corticosteroid from dications (41.2% in any optimal window), followed by preterm premature
2006-2012 at the University of Washington Medical Center with the use of rupture of membranes (32.1%). Lowest administration accuracy was
the University of Washington Medical Center Pharmacy Database. For among women with antenatal cervical shortening and advanced cervical
inclusion, subjects were required to be admitted, receive the initial dilation; only 2.8% and 6.3% delivered within the optimal window,
antenatal corticosteroid course at 24-34 weeks gestation, and deliver at respectively. Furthermore, for women with antenatal cervical shortening,
University of Washington Medical Center. We designated 2 groups that the mean gestational age of delivery was 35.1 weeks, and the median
were based on when rescue antenatal corticosteroid became standard interval from antenatal corticosteroid administration to delivery was 55
practice at University of Washington Medical Center: before rescue days (interquartile range, 34e72 days).
antenatal corticosteroid (2006-2008) and after rescue antenatal cortico- CONCLUSIONS: The opportunity for a second course of antenatal
steroid (2009-2012). Primary outcome was delivery within any optimal corticosteroid did not improve the number of women who delivered within
antenatal corticosteroid window, which was defined as 48 hours to 7 days any optimal antenatal corticosteroid window. Administration timing was
after the first dose or third dose. We also compared delivery within the similar for the initial course and the rescue course, with approximately
optimal window of the initial and rescue antenatal corticosteroid courses one-quarter of women delivering within the optimal antenatal corticoste-
independently and assessed antenatal corticosteroid timing by the roid window. These findings likely reflect the few circumstances in which
indication for delivery. Chi squared and independent sample t-tests were rescue antenatal corticosteroid is useful and the poor predictability of
used to compare results. preterm birth. Future focus should be aimed at tools to predict the timing of
RESULTS: From 2006-2012, 1356 women met inclusion criteria, 601 preterm birth to optimize antenatal corticosteroid administration.
before and 755 after rescue antenatal corticosteroid. The study groups
demonstrated similar demographics, with the exception of more white Key words: antenatal corticosteroid, preterm birth, rescue course,
women in the group after rescue antenatal corticosteroid (47% vs 60%; timing

A ntenatal corticosteroids (ACS) are


an important intervention used to
improve neonatal outcomes after pre-
distress syndrome, and intensive care
admissions.2 ACS offer the greatest
benet to the fetus if the infant is deliv-
optimal window.12,13 In 2011 and 2012,
the American College of Obstetricians
and Gynecologists endorsed the admin-
term birth. Since the landmark study by ered 24-48 hours after the initial dose istration of a single course of rescue
Liggins and Howie1 in 1972, several and within 7 days of the administra- steroids for women who remain at risk
studies have conrmed that treatment tion.2,3 Benets decrease after this for preterm delivery, commonly known
with ACS is associated with an overall optimal window.4-7 However, prediction as the rescue protocol.14
reduction in neonatal death, respiratory of preterm birth is challenging, espe- Studies demonstrate that most
cially within a narrow timeframe. women who receive an initial dose of
Although 1 strategy to improve the ACS deliver at <34 weeks gestation, but
Cite this article as: Makhija NK, Tronnes AA, Dunlap BS, timing of the administration is to pro- the accuracy of administration within
et al. Antenatal corticosteroid timing: accuracy after the vide repeated courses of ACS, studies the optimal window is low and varies by
introduction of a rescue course protocol. Am J Obstet
demonstrate that multiple courses carry indication for delivery.15-20 The accuracy
Gynecol 2016;214:120.e1-6.
fetal risks.8-11 More recent research of rescue ACS administration remains
0002-9378/$36.00 demonstrates that a single rescue course unknown. Recently, studies that have
2016 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ajog.2015.08.018 of ACS may also improve neonatal demonstrated combined increased use
outcomes, when delivered within the and inaccurate timing of ACS have raised

120.e1 American Journal of Obstetrics & Gynecology JANUARY 2016


ajog.org OBSTETRICS Original Research

concern for long-term harmful effects Two groups were identied according this time point in clinical decision-
on infants who are born outside of the to the year of initial ACS course admin- making and delivery planning. The sec-
optimal window.17,21 Furthermore, few istration. In 2009, the Maternal Fetal ondary outcomes included delivery
data report on the long-term harm of a Medicine group at the University of within an optimal window of the rescue
single rescue course of ACS. For these Washington Medical Center developed course and delivery within the optimal
reasons, ensuring that the availability of a consensus policy that supported the window of the initial ACS course.
rescue course ACS increases the number use of a single rescue course of ACS. The Additionally, we assessed delivery timing
of women who receive ACS within rst group received the initial ACS and delivery characteristics by indication
any optimal window remains a priority. course between 2006 and 2008, which for administration.
Our objective was to compare the accu- was before the implementation of our Sample size was determined by the
racy of ACS administration before and rescue steroid protocol; the second availability of subjects who received ACS
after the availability of a rescue course group received an initial ACS course within the study time period. With our
protocol and to determine whether between 2009 and 2012, which was after sample size of 1356 women, the
rescue ACS increase the proportion of widespread use of the rescue course assumption was that 30% of the women
women who deliver within any optimal protocol. received ACS within the optimal window
ACS window. We compared maternal, pregnancy, (a .05; power of 80%; the minimal
and delivery characteristics between the effect size detectable is 7%). Statistical
Materials and Methods groups before and after the availability of analysis was completed using STATA
We conducted a retrospective cohort rescue steroids. The potential indications software (version 11.1; Stata Corpora-
study of women who had received ACS, for the administration of ACS were tion, College Station, TX). Pearson chi-
comparing the proportion of patients categorized as preterm labor, preterm squared tests were used to compare
who delivered in the optimal window of premature rupture of membranes, categoric variables, and independent
the initial ACS course before and after antenatal cervical shortening, advanced sample t-tests were used to compare
the availability of rescue ACS. We iden- cervical dilation, vaginal bleeding, continuous variables. For all analyses, a
tied subjects using the inpatient hos- maternal factors, and fetal factors. Pre- 2-sided signicance level of < .05 was
pital pharmacy database, capturing all term labor was dened as regular, painful considered statistically signicant.
women who were admitted to the labor contractions with cervical change.
and delivery unit. Women were included Antenatal cervical shortening was used Results
if they received at least 1 dose of ACS to describe women who were asymp- We identied 1809 pregnant women for
between January 2006 and December tomatic but found to have a cervical whom a pharmacy order was placed for
2012 at the University of Washington length of <2 cm on transvaginal ultra- betamethasone within the study period.
Medical Center, a level 3-referral hospi- sound scans. Many of these women had After exclusions for not receiving ACS,
tal. Data were then linked to the Uni- additional risk factors for preterm birth. delivering at an outside hospital, or
versity of Washington Perinatal Database Advanced cervical dilation was dened as gestational age, the nal study popula-
for additional demographic data. A sin- dilation of >2 cm, and patients were tion was 1356 subjects (Figure 1). Of the
gle primary researcher then performed a given this diagnosis only if they did not total cohort, 601 women received ACS
review of each chart to conrm and meet criteria for preterm labor. If pa- from 2006-2008 before availability of
obtain additional data. The Human tients had >1 indication, the investigator rescue protocol, and 755 women
Subjects Division at the University of assigned a primary indication. We
Washington approved this study. compared the proportion of patients
The cohort included women who who had delivered within the optimal
were admitted to labor and delivery window before and after the availability FIGURE 1
and received at least 1 dose of beta- of a rescue course protocol. Study population flowchart
methasone 12 mg intramuscularly, The primary outcome was delivery
which is the ACS used almost exclu- within the optimal window of either the
sively at our and referring institutions. initial ACS course or the rescue ACS
Patients were excluded if they received course. The optimal window for ACS
betamethasone at <24 0/7 weeks administration is dened as delivery
gestation or >33 6/7 weeks gestation, if between 48 hours and 7 days after the
they delivered at an outside institution, rst dose for the initial course and be-
or if we could not conrm the tween 48 hours and 7 days after the third
administration of ACS by chart review. dose for the rescue course. Although
Some women received their rst dose data suggest that steroid benet can
of ACS before transfer to our institu- occur after 24 hours from the rst dose, ACS, antenatal corticosteroids; OSH, outside hospital.
Makhija et al. Rescue course antenatal corticosteroid timing.
tion; they were included if ACS our institution routinely considers Am J Obstet Gynecol 2016.
administration was conrmed. maximum benet at 48 hours and uses

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Original Research OBSTETRICS ajog.org

TABLE 1 FIGURE 2
Demographic and pregnancy characteristics between groups before and Delivery within the optimal
after availability of rescue course protocol: 2006-2008 vs 2009-2012 window of antenatal
corticosteroids before and after
Group 1: before Group 2: after availability of a rescue course
rescue availability rescue availability
Maternal characteristics (n 601), n (%) (n 755), n (%) P value
Maternal age, y .97
<20 48 (8) 56 (7.4)
20-34 418 (69.5) 528 (70.0)
35 135 (22.5) 171 (22.6)
Race < .01
Black 75 (12.5) 100 (13.2)
White 283 (47.1) 453 (60.0)
Asian 17 (2.8) 17 (2.3)
Hispanic 73 (12.2) 90 (119)
Native American 8 (1.3) 11 (1.5)
Pacific Islander 29 (19.3) 40 (5.8)
Other 116 (4.8) 44 (5.3)
a
Previous preterm delivery 112 (18.6) 145 (19.2) .74
Previous cesarean delivery 105 (17.5) 124 (16.9) .61
Multiple gestation 88 (14.6) 110 (14.6) .97
Transfer from referral center 134 (22.3) 200 (26.5) .07
Hypertension 93 (15.5) 123 (16.3) .68
Diabetes mellitus 57 (9.5) 66 (8.7) .64
b
Other major medical comorbidity 34 (5.6) 50 (6.6) .46
Delivery at <34 weeks gestation 367 (62.1) 464 (62.9) .10
a
Defined as any delivery after 20 weeks gestation; b Includes cardiac disease, renal disease, pulmonary disease, autoimmune
disease, malignancy.
Makhija et al. Rescue course antenatal corticosteroid timing. Am J Obstet Gynecol 2016. Delivery within the optimal window of antenatal
corticosteroids for A, the initial course, B, the
rescue course, and C, any antenatal course.
Optimal window is defined as delivery >48
received ACS from 2009-2012 after comorbidities in our study group. As hours and <7 days after administration of
availability of rescue protocol. Of note, anticipated, there was a high proportion antenatal corticosteroids.
similar proportions of patients were of preterm deliveries. The study groups ACS, antenatal corticosteroids; d, day; h, hour.
excluded from each group because of delivered at similar gestational ages, with Makhija et al. Rescue course antenatal corticosteroid timing.
Am J Obstet Gynecol 2016.
delivery at an outside institution (20.2% approximately 62% of the population
before rescue ACS vs 18% after rescue delivering at <34 weeks gestation.
ACS; P .24). However, women who The primary outcome of delivery
were included in the study were on within the optimal window of either the appeared stable over time (Figure 3).
average 1.7 years older than those initial or rescue ACS course did not Finally, when the data were stratied by
excluded for outside hospital delivery (P change after the availability of rescue gestational age, there was no statistical
< .01). Additional demographic data on ACS (26.5% before rescue ACS vs 28.5% difference in the proportion of patients
the excluded group were not accessible. after rescue ACS; P .41; Figure 2, C). who delivered in any optimal window
Table 1 gives the maternal character- Considering the interval to delivery as a before and after the availability of
istics of our population. Study groups continuous variable did not impact our rescue steroids (24-28 weeks gestation:
were similar, with the exception of racial results (23.1 days before rescue ACS vs 43.5% before rescue ACS vs 51.6% after
distribution. There was a high repre- 23.7 days after rescue ACS; P .66). rescue ACS [P .5]; 28-32 weeks
sentation of multiple gestations, transfer Furthermore, when we examined the gestation: 35.7% vs 42.6% [P .42];
to higher level of care, hypertension, accuracy of administration over the 32-34 weeks gestation: 39.4% vs 36.57%
diabetes mellitus, and other medical study years, ACS use and accuracy [P .84]).

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ajog.org OBSTETRICS Original Research

The availability of a rescue course antenatal cervical shortening was 27.2


FIGURE 3
ACS also did not change the timing of weeks. However, mean gestational age at
Accuracy of antenatal
the initial course administration delivery was 35.1 weeks, and the median
corticosteroid administration in
any optimal window over the (26.1% before rescue ACS vs 26.4% time to delivery for women with ante-
study years after rescue ACS; P .93; Figure 2, A). natal cervical shortening was 55 days
Similarly, only 24.7% of patients who (interquartile range, 34e72), which was
received rescue ACS delivered within longer than any other indication.
the optimal window of the rescue Women who received rescue dose
course (Figure 2, B). Of note, 787 of steroids did not receive them neces-
all women (58%) in the study cohort sarily for the same indication for
delivered beyond 7 days after the which they received the initial course
initial ACS dose. (Table 2). Although these 2 pop-
Delivery within the optimal window ulations were not compared directly,
differed by indication for ACS (Table 2). distribution of delivery within the
Accuracy of administration was highest optimal window and median time to
for maternal indications and lowest delivery was similar for the initial
Accuracy of antenatal corticosteroid adminis- when given for antenatal cervical short- course and the rescue course.
tration over time.
ening. Mean gestational age at adminis-
d, day; h, hour.
Makhija et al. Rescue course antenatal corticosteroid timing.
tration and at delivery is also noted in Comment
Am J Obstet Gynecol 2016. Table 2. Notably, mean gestational age of This study demonstrated that the avail-
women who received initial ACS for ability of a rescue ACS course did not

TABLE 2
Delivery timing and characteristics based on indication for antenatal corticosteroids
Mean gestational
age of antenatal Median interval
Delivery Delivery at corticosteroid Mean gestational to delivery, d
at <48 48 hours to Delivery at administration, age at delivery, (interquartile
Indication Total hours, n (%) 7 days, n (%) >7 days, n (%) wk  SD wk  SD range)
Initial antenatal corticosteroid
administration (n 1359)
Preterm labor 297 57 (19.2) 53 (17.9) 187 (62.9) 29.6  3.1 33.3  4.5 18 (3e43)
Preterm premature rupture of 246 58 (23.6) 79 (32.1) 109 (44.3) 29.3  3.2 31.0  3.2 6 (2e15)
membranes
Antenatal cervical shortening 106 0 3 (2.8) 103 (97.2) 27.2  2.4 35.1  3.8 55 (34e72)
Advanced cervical dilation 32 1 (3.1) 2 (6.3) 29 (90.6) 28.1  3.2 32.9  5.1 31 (18e45)
Vaginal bleeding 133 9 (6.8) 22 (16.5) 102 (76.7) 28.4  3.1 33.5  4.6 28 (9e54)
Maternal factors 352 63 (17.9) 145 (41.2) 144 (40.9) 29.4  2.7 32.1  3.5 5 (2e23)
Fetal factors 190 25 (13.1) 52 (27.4) 113 (59.5) 29.7  2.7 32.9  3.4 15 (4e37)
Rescue antenatal corticosteroid
administration (n 73)
Preterm labor 22 7 (31.8) 6 (27.3) 9 (40.9) 30.2  2.0 32.3  3.2 19 (3e43)
Preterm premature rupture of 10 3 (30.0) 3 (30.0) 4 (40.0) 29.9  1.8 31.1  2.2 4 (1e9)
membranes
Antenatal cervical shortening 0 0 0 0 0 0 0
Advanced cervical dilation 5 0 1 (20.0) 4 (80.0) 31.4  1.1 34.7  2.6 25 (14e33)
Vaginal bleeding 6 0 0 6 (100.0) 30.8  1.6 35.2  1.6 29 (28e40)
Maternal factors 8 5 (62.5) 1 (12.5) 2 (25.0) 30.4  1.6 31.6  2.5 2 (1e7)
Fetal factors 22 6 (27.3) 7 (31.8) 9 (40.9) 31.0  2.0 32.5  2.4 6 (2e18)
SD, standard deviation.
Makhija et al. Rescue course antenatal corticosteroid timing. Am J Obstet Gynecol 2016.

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Original Research OBSTETRICS ajog.org

improve the overall accuracy of ACS We found that, when steroids were but a low optimal ACS use. With concern
timing within any optimal window. The administered for the initial indication for the over utilization of ACS, strategies
proportion of women who delivered of antenatal cervical shortening, accu- to optimize the timing of administra-
within the optimal window for the racy in predicting delivery in the tion, such as withholding steroids for an
rescue ACS course was similar to the optimal window was low (2.8% deliv- indication of isolated antenatal cervical
initial course, both of which were timed ered in the optimal window and >97% shortening, may decrease unnecessary
optimally approximately 25% of the of these patients delivered after 7 days exposure.
time. These ndings likely reect the few from the initial ACS administration). This study reiterates the difculty in
circumstances in which rescue ACS is Further analysis revealed that 62.5% predicting preterm birth. Future focus
useful and the poor predictability of of people with cervical shortening should be aimed at tools to predict the
preterm birth. delivered at >34 weeks gestation. timing of preterm birth to optimize ACS
Little data are available regarding the However, excluding patients with ante- administration. With nearly 60% of
accuracy of rescue ACS timing. A num- natal cervical shortening from the women delivering after the optimal
ber of previous studies have looked at the analysis did not result in a large change window for both initial course and
accuracy of the timing of initial ACS in the proportion of women who rescue course ACS, one must consider
administration and demonstrate accu- delivered in the optimal window (28% the impact on ongoing pregnancies and
racy between 20% and 48%.15,16,18-20 As excluding antenatal cervical shortening the need for data regarding harm. n
one would anticipate, accuracy of compared with 26% including cervical
administration is higher in studies that shortening). Acknowledgments
focus on indicated preterm birth because This is a large cohort study of patients The authors thank Lisa S. Ray at the University of
the health care provider often dictates who received ACS at a single institution. Washington for her assistance in building the
delivery timing.15 However, 2 studies Although our primary outcome sample data set, Dr Melissa Schiff for programming
assistance, and Jan Hamanishi for gure design.
that included patients with both labor size was large, the use of rescue steroids
and nonlabor indications for the is low; thus, the number of people who
administration found higher rates of received the rescue course was small. References
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Author and article information
Newnham JP. Repeated antenatal corticoste- Joseph KS. Trends in optimal, suboptimal, and From Department of Obstetrics and Gynecology (Drs
roids: size at birth and subsequent develop- questionably appropriate receipt of antenatal Makhija, Tronnes, Schulkin, and Lannon) and the
ment. Am J Obstet Gynecol 1999;180:114-21. corticosteroid prophylaxis. Obstet Gynecol Department of Medicine (Mr Dunlap), University of
12. Garite TJ, Kurtzman J, Maurel K, Clark R. 2015;125:288-96. Washington School of Medicine, Seattle, WA; and the
Impact of a rescue course of antenatal corti- 18. Boesveld M, Heida KY, Oudijk MA, American College of Obstetricians and Gynecologists,
costeroids: a multicenter randomized placebo- Brouwers HA, Koenen SV, Kwee A. Evaluation Research Department, Washington, DC (Dr Schulkin).
controlled trial. Am J Obstet Gynecol of antenatal corticosteroid prescribing pat- Received May 20, 2015; revised July 10, 2015;
2009;200:248.e1-9. terns among 984 women at risk for preterm accepted Aug. 10, 2015.
13. Vermillion ST, Bland ML, Soper DE. Effec- delivery. J Matern Fetal Neonatal Med 2014;27: The authors report no conflict of interest.
tiveness of a rescue dose of antenatal betame- 516-9. Presented in abstract form at the 35th Annual Preg-
thasone after an initial single course. Am J 19. Vis JY, Wilms FF, Kuin RA, et al. Time to nancy Meeting of the Society for Maternal-Fetal Medi-
Obstet Gynecol 2001;185:1086-9. delivery after the rst course of antenatal corti- cine, San Diego, CA, Feb. 6, 2015.
14. American College of Obstetricians and Gy- costeroids: a cohort study. Am J Perinatol Corresponding author: Neeta K Makhija, MD.
necologists. Antenatal corticosteroid therapy for 2011;28:683-8. neeta.makhija@gmail.com

JANUARY 2016 American Journal of Obstetrics & Gynecology 120.e6

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