Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
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

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.

PubMed Disclaimer

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.

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.

Similar articles

Cited by

References

    1. Williams O, Michel B, Hutchings G, Debauche C, Hubinont C. Two‐year neonatal outcome following PPROM prior to 25 weeks with a prolonged period of oligohydramnios. Early Hum Dev 2012;88:657–61. - PubMed
    1. Nourse CB, Steer PA. Perinatal outcome following conservative management of mid‐trimester pre‐labour rupture of the membranes. J Paediatr Child Health 1997;33:125–30. - PubMed
    1. Mercer BM. Preterm premature rupture of the membranes: current approaches to evaluation and management. Obstet Gynecol Clin North Am 2005;32:411–28. - PubMed
    1. Hibbard JU, Hibbard MC, Ismail M, Arendt E. Pregnancy outcome after expectant management of premature rupture of the membranes in the second trimester. J Reprod Med 1993;38:945–51. - PubMed
    1. Vintzileos AM, Campbell WA, Nochimson DJ, Weinbaum PJ. Degree of oligohydramnios and pregnancy outcome in patients with premature rupture of the membranes. Obstet Gynecol 1985;66:162–7. - PubMed

Publication types

Substances