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

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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
Early online date4 Mar 2020
Publication statusPublished - Jan 2021


  • Follow up
  • infant development
  • neurodevelopment
  • oligohydramnios
  • second-trimester prelabour rupture of the membranes

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