To compare the effects of immediate delivery an expectant management among women whose pregnancies were complicated by preterm prelabor rupture of membranes (PROM) in the late preterm period (from 34 0/7 weeks until 36 6/7 weeks of gestation).
PubMed, Scopus, ClinicalTrials.gov, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception until December 2016.
We included all randomized controlled trials with individual participant data reporting on late preterm PROM with randomization to immediate delivery or expectant management. The primary outcome was a composite of adverse neonatal outcomes: probable or definitive neonatal sepsis, necrotizing enterocolitis, respiratory distress syndrome, stillbirth, or neonatal death.
Of eight eligible trials (total n=3,203 mothers), three (2,563 mothers, 2,572 neonates) had individual participant data available. The composite adverse neonatal outcome occurred in 9.6% of neonates in the immediate delivery group and 8.3% in the expectant management group (relative risk [RR] 1.20, 95% CI 0.94–1.55). Neonatal sepsis rates were 2.6% and 3.5%, respectively (RR 0.74, 95% CI 0.47–1.15). Neonates in the immediate delivery group were more likely to be diagnosed with respiratory distress syndrome (RR 1.47, 95% CI 1.10–1.97), and to be admitted to the neonatal intensive care unit or special care nursery (RR 1.17, 95% CI 1.11–1.23) and had longer admissions. Mothers randomized to immediate delivery were less likely to have an antepartum hemorrhage (RR 0.57, 95% CI 0.34–0.95) or chorioamnionitis (RR 0.21, 95% CI 0.13–0.35), but more likely to undergo cesarean delivery (RR 1.26, 95% CI 1.08–1.47).
In women with late preterm PROM, immediate delivery and expectant management resulted in comparable rates of the composite of adverse neonatal outcomes. Effects on individual secondary maternal and neonatal outcomes were mixed.
PROSPERO, 42016032972.
Planned early birth after late preterm prelabor rupture of membranes does not improve a composite of adverse neonatal outcomes.
Departments of Obstetrics and Gynecology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, and Academic Medical Centre, Amsterdam, the Netherlands; the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia; the Department of Obstetrics and Gynaecology, Martini Hospital Groningen, Groningen, and the Department of Obstetrics and Gynecology, Maastricht University Medical Center, Maastricht, the Netherlands; Clinical and Population Perinatal Health Research, Kolling Institute, University of Sydney at Royal North Shore Hospital, St. Leonards, and Clinical and Population Perinatal Health Research, Kolling Institute, University of Sydney, Sydney, New South Wales, and Paediatrics and Reproductive Health, University of Adelaide, Adelaide, South Australia, Australia.
Corresponding author: Johanna Quist-Nelson, MD, Department of Obstetrics and Gynecology, Thomas Jefferson University Hospital, 833 Chestnut Street, Mezzanine Level, Philadelphia, PA 19107; email: Johanna.quist-nelson@jefferson.edu.
Ben W. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548).
Financial Disclosure Dr. van der Ham was first author on both of the PPROMEXIL trials. Dr. Morris was the first author of the PPROMT study. Dr. Mol has been a consultant for ObsEva, Merck, and Guerbet. The other authors did not report any potential conflicts of interest.
Presented at 16th Fetal Medicine Foundation World Congress, June 25–29, 2017, Ljubljana, Slovenia.
The authors thank the contributors of PPROMEXIL, PPROMEXIL-2, PPROMT. For a list of contributors to the PPROMEXIL and PPROMEXIL-2 trials and a list of contributors to the PPROMT trial, see Appendix 1, available online at http://links.lww.com/AOG/B57.
The authors thank Gary Kaplan for librarian assistance with the systematic review.
Each author has indicated that he or she has met the journal's requirements for authorship.
