Child outcomes after amnioinfusion compared with no intervention in women with second-trimester rupture of membranes: a long-term follow-up study of the PROMEXIL-III trial

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, L. E.M. van Kempen, T. J. Roseboom, B. W. Mol, E. Pajkrt

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Objective: To assess the effect of transabdominal amnioinfusion or no intervention on long-term outcomes in children born after second-trimester prelabour rupture of the membranes (PROM between 16+0/7–24+0/7 weeks) and oligohydramnios. Population: Follow up of infants of women who participated in the randomised controlled trial: PPROMEXIL-III (NTR3492). Methods: Surviving infants were invited for neurodevelopmental assessment up to 5 years of corrected age using a Bayley Scales of Infant and Toddler Development or a Wechsler Preschool and Primary Scale of Intelligence. Parents were asked to complete several questionnaires. Main outcome measures: Neurodevelopmental outcomes were measured. Mild delay was defined as −1 standard deviation (SD), severe delay as −2 SD. Healthy long-term survival was defined as survival without neurodevelopmental delay or respiratory problems. Results: In the amnioinfusion group, 18/28 children (64%) died versus 21/28 (75%) in the no intervention group (relative risk 0.86; 95% confidence interval [CI] 0.60–1.22). Follow-up data were obtained from 14/17 (82%) children (10 amnioinfusion, 4 no intervention). In both groups, 2/28 (7.1%) had a mild neurodevelopmental delay. No severe delay was seen. Healthy long-term survival occurred in 5/28 children (17.9%) after amnioinfusion versus 2/28 (7.1%) after no intervention (odds ratio 2.50; 95% CI 0.53–11.83). When analysing data for all assessed survivors, 10/14 (71.4%) survived without mild neurodevelopmental delay and 7/14 (50%) were classified healthy long-term survivor. Conclusions: In this small sample of women suffering second-trimester PROM and oligohydramnios, amnioinfusion did not improve long-term outcomes. Overall, 71% of survivors had no neurodevelopmental delay. Tweetable abstract: Healthy long-term survival was comparable for children born after second-trimester PROM and treatment with amnioinfusion or no intervention.

Original languageEnglish
Pages (from-to)292-301
Number of pages10
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Issue number2
Publication statusPublished - Jan 2021

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