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Amnioinfusion Compared With No Intervention in Women With Second-Trimester Rupture of Membranes

A Randomized Controlled Trial

van Kempen, Liselotte E. M., MD; van Teeffelen, Augustinus S., MD, PhD; de Ruigh, Annemijn A., MD; Oepkes, Dick, MD, PhD; Haak, Monique C., MD, PhD; van Leeuwen, Elisabeth, MD, PhD; Woiski, Mallory, MD, PhD; Porath, Martina M., MD, PhD; Bax, Caroline J., MD, PhD; van Wassenaer-Leemhuis, Aleid G., MD, PhD; Mulder, Antonius L., MD, PhD; van der Ham, David P., MD, PhD; Willekes, Christine, MD, PhD; Franssen, Maureen T., MD, PhD; Derks, Jan B., MD, PhD; Schuit, Ewoud, PhD; Mol, Ben W., MD, PhD; Pajkrt, Eva, MD, PhD

doi: 10.1097/AOG.0000000000003003
Obstetric Complications: Original Research: PDF Only

OBJECTIVE: To assess the effectiveness of amnioinfusion in women with second-trimester preterm prelabor rupture of membranes.

METHODS: We performed a nationwide, multicenter, open-label, randomized controlled trial, the PPROM: Expectant Management versus Induction of Labor-III (PPROMEXIL-III) trial, in women with singleton pregnancies and preterm prelabor rupture of membranes at 16 0/7 to 24 0/7 weeks of gestation with oligohydramnios (single deepest pocket less than 20 mm). Participants were allocated to transabdominal amnioinfusion or no intervention in a one-to-one ratio by a web-based system. If the single deepest pocket was less than 20 mm on follow-up visits, amnioinfusion was repeated weekly until 28 0/7 weeks of gestation. The primary outcome was perinatal mortality. We needed 56 women to show a reduction in perinatal mortality from 70% to 35% (β error 0.20, two-sided α error 0.05).

RESULTS: Between June 15, 2012, and January 13, 2016, we randomized 28 women to amnioinfusion and 28 to no intervention. One woman was enrolled before the trial registration date (June 19, 2012). Perinatal mortality rates were 18 of 28 (64%) in the amnioinfusion group vs 21 of 28 (75%) in the no intervention group (relative risk 0.86, 95% CI 0.60–1.22, P=.39).

CONCLUSION: In women with second-trimester preterm prelabor rupture of membranes and oligohydramnios, we found no reduction in perinatal mortality after amnioinfusion.

CLINICAL TRIAL REGISTRATION: NTR Dutch Trial Register, NTR3492.

Amnioinfusion does not improve perinatal outcome in pregnancies complicated by second-trimester preterm prelabor rupture of membranes.

Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, the Departments of Obstetrics and Gynecology and Pediatrics, Grow, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, the Department of Obstetrics, Leiden University Medical Center, Leiden, the Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, the Department of Obstetrics and Gynecology, Maxima Medical Center, Veldhoven, the Department of Obstetrics and Gynecology, VU University Medical Center, Amsterdam, the Department of Neonatology, Emma Children’s Hospital Academic Medical Center, Amsterdam, the Department of Obstetrics and Gynecology, Martini Hospital, Groningen, the Department of Obstetrics and Gynecology, University Medical Center Groningen, Groningen, and the Department of Obstetrics and Gynecology and the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands; and Robinson Research Institute, School of Medicine, University of Adelaide, Adelaide, Australia.

Corresponding author: Eva Pajkrt, MD, PhD, Department of Obstetrics and Gynecology, Academic Medical Center (AMC), Amsterdam, PO Box 22660, 1100 DD, the Netherlands; email: e.pajkrt@amc.nl.

Ben W. Mol is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548).

Financial Disclosure Ben W. Mol reports consultancy for ObsEva, Merck, and Guerbet. The other authors did not report any potential conflicts of interest.

Presented at the 37th Annual Meeting of the Society for Maternal-Fetal Medicine, January 23–28, 2017, Las Vegas, Nevada; the 21st Annual Meeting of the Perinatal Society of Australia & New Zealand, April 2–5, 2017, Canberra, Australia; the 16th Fetal Medicine Foundation World Congress, June 25–29, 2017, Ljubljana, Slovenia; and the 52nd Gynaecongres, November 16–17, 2017, Amersfoort, the Netherlands.

Each author has confirmed compliance with the journal’s requirements for authorship.

Peer reviews and author correspondence are available at http://links.lww.com/AOG/B212.

Received August 06, 2018

Received in revised form September 26, 2018

Accepted October 04, 2018

© 2018 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.