Liselotte E M van Kempen1, Augustinus S van Teeffelen, Annemijn A de Ruigh, Dick Oepkes, Monique C Haak, Elisabeth van Leeuwen, Mallory Woiski, Martina M Porath, Caroline J Bax, Aleid G van Wassenaer-Leemhuis, Antonius L Mulder, David P van der Ham, Christine Willekes, Maureen T Franssen, Jan B Derks, Ewoud Schuit, Ben W Mol, Eva Pajkrt. 1. 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.
Abstract
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.
RCT Entities:
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.
Authors: A A de Ruigh; N E Simons; J van 't Hooft; A S van Teeffelen; R G Duijnhoven; A G van Wassenaer-Leemhuis; C Aarnoudse-Moens; C van de Beek; D Oepkes; M C Haak; M Woiski; M M Porath; J B Derks; Lem van Kempen; T J Roseboom; B W Mol; E Pajkrt Journal: BJOG Date: 2020-03-04 Impact factor: 7.331
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