.png)
Late-Breaking Research Presentation Session 5
Late-breaking Research Sessions
Expedited Sessions
An initial course of antenatal corticosteroids (ACS) is indicated after preterm prelabor rupture of membranes (PPROM). For patients who remain undelivered 7 days or more after initial ACS, it is uncertain whether a booster course of ACS reduces neonatal morbidity or increases infection risk. Our objective was to test whether a single booster course of ACS improves neonatal outcomes after PPROM.
Study Design:
We conducted a multicenter, placebo-controlled randomized clinical trial (RCT). Inclusion criteria were: PPROM, gestational age (GA) 24.0-31.9 weeks, singleton, initial ACS course at least 7 days before randomization, planned expectant management. Consenting patients were randomized in GA blocks to booster ACS (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 ACS 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 ACS vs 66% with placebo (odds ratio 0.82, 95% CI 0.43-1.57, GA-stratified Cochran-Mantel-Haenszel test). Individual components of the primary outcome (Table 1) and secondary neonatal and maternal outcomes (Table 2) were not significantly different between ACS and placebo groups.
Conclusion:
A booster course of ACS at least 7 days after the first ACS course in PPROM patients did not improve neonatal morbidity or any other outcome in this adequately-powered, double-blind RCT. Booster ACS did not increase maternal or neonatal infection.
Richard P. Porreco, MD
Obstetrix Medical Group of Colorado
Denver, Colorado, United States
Andrew Combs, MD, PhD
Obstetrix Medical Group
Obstetrix Medical Group of California
Campbell, California, United States
.jpg "Thomas J. Garite, MD photo")
Thomas J. Garite, MD
Professor Emeritus
University of California, Irvine
Grand JCT, Colorado, United States
Kimberly A. Maurel, MSN, RN (she/her/hers)
Associate Director of Research
Pediatrix -The Center for Research Education Quality and Safety
Fountain Valley, California, United States
Christopher Huls, MD, MSCR
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Susan Baker, MD
University of South Alabama College of Medicine
Mobile, Alabama, United States
Kimberly B. Fortner, MD (she/her/hers)
Professor and MFM Fellowship Program Director
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States
Sherri Longo, MD
Maternal-Fetal Medicine Physician
Ochsner Medical center
New Orleans, Louisiana, United States
Michael P. Nageotte, MD
Miller Children's and Women's Hospital
Long Beach, California, United States
David Lewis, MD
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
Lan Tran, MD
Swedish Medical Center
Seattle, Washington, United States