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Randomized Controlled Trial
. 2021 Jan;128(2):292-301.
doi: 10.1111/1471-0528.16115. Epub 2020 Mar 4.

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  1 , N E Simons  1 , J van 't Hooft  1 , A S van Teeffelen  2 , R G Duijnhoven  1 , A G van Wassenaer-Leemhuis  3 , C Aarnoudse-Moens  3 , C van de Beek  4 , D Oepkes  5 , M C Haak  5 , M Woiski  6 , M M Porath  7 , J B Derks  8 , Lem van Kempen  1 , T J Roseboom  4 , B W Mol  9 , E Pajkrt  1
Affiliations
Randomized Controlled Trial

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 et al. BJOG. 2021 Jan.

Abstract

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.

Keywords: Follow up; infant development; neurodevelopment; oligohydramnios; second-trimester prelabour rupture of the membranes.

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Figures

Figure 1
Figure 1
Flowchart of all participating mothers in the PPROMEXIL‐III trial and their children in the follow‐up study.
Figure 2
Figure 2
Neurodevelopmental outcomes of children participating in follow up, when analysing data irrespectively of trial assignment.
See this image and copyright information in PMC

Comment in

  • Abandon ship?
    Skupski DW. Skupski DW. BJOG. 2021 Jan;128(2):302. doi: 10.1111/1471-0528.16187. Epub 2020 Mar 12. BJOG. 2021. PMID: 32115855 No abstract available.

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