ABSTRACT
Background
Preterm prelabor rupture of membranes is a leading cause of preterm birth and is responsible
for 18-20% of perinatal deaths in this country. An initial course of antenatal corticosteroids
has been shown to reduce morbidity and mortality in preterm prelabor rupture of membranes.
For patients who remain undelivered 7 days or more after initial course of antenatal
corticosteroids, it is uncertain whether a booster course of antenatal corticosteroids
reduces neonatal morbidity or increases infection risk. ACOG has concluded that evidence
is insufficient to make a recommendation.
Objective
Our objective was to test whether a single booster course of antenatal corticosteroids
improves neonatal outcomes after preterm prelabor rupture of membranes.
Study Design
We conducted a multicenter, placebo-controlled randomized clinical trial. Inclusion
criteria were: preterm prelabor rupture of membranes, gestational age 24.0-32.9 weeks,
singleton, initial antenatal corticosteroid course at least 7 days before randomization,
planned expectant management. Consenting patients were randomized in gestational age
blocks to booster antenatal corticosteroids (betamethasone 12 mg q24h x 2) or saline
placebo. The primary outcome was composite neonatal morbidity or death. A sample size
of 194 patients was calculated to yield 80% power at P<0.05 to detect reduction of
primary outcome from 60% in placebo group to 40% in antenatal corticosteroids group.
Results
From April 2016 through August 2022, 194 patients consented and were randomized (47%
of 411 eligible). Intent-to-treat analysis was performed on 192 patients (two placebo
patients left hospital, outcomes unknown). The groups had similar baseline characteristics.
The primary outcome occurred in 64% with booster antenatal corticosteroids vs 66%
with placebo (odds ratio 0.82, 95% CI 0.43-1.57, gestational age-stratified Cochran-Mantel-Haenszel
test). Individual components of the primary outcome and secondary neonatal and maternal
outcomes were not significantly different between antenatal corticosteroids and placebo
groups. Specifically, chorioamnionitis (22% vs 20%, respectively), postpartum endometritis
(1% vs 2%), wound infections (2% vs 0%), and proven neonatal sepsis (5% vs 3%) were
not different between groups.
Conclusions
A booster course of antenatal corticosteroids at least 7 days after the first antenatal
corticosteroids course in preterm prelabor rupture of membranes patients did not improve
neonatal morbidity or any other outcome in this adequately-powered, double-blind randomized
clinical trial. Booster antenatal corticosteroids did not increase maternal or neonatal
infection.
Keywords
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Article info
Publication history
Accepted:
January 31,
2023
Received:
January 30,
2023
Publication stage
In Press Accepted ManuscriptFootnotes
For the Obstetrix Collaborative Research Network
Presented at the 43rd Annual Pregnancy Meeting, Society for Maternal-Fetal Medicine, San Francisco, CA, February 6-11, 2023. Oral presentation # LB-07.
Identification
Copyright
© 2023 Elsevier Inc. All rights reserved.
