Evidence map›Paper›PMID 31984652›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2021

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 and 7 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 19 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 6 institutions in 2 countries.

A A de RuighDepartment of Obstetrics and Gynaecology, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
N E SimonsDepartment of Obstetrics and Gynaecology, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
J van 't HooftDepartment of Obstetrics and Gynaecology, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
A S van TeeffelenDepartment of Obstetrics and Gynaecology, Grow, School for Oncology and Developmental Biology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
R G DuijnhovenDepartment of Obstetrics and Gynaecology, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
A G van Wassenaer-LeemhuisDepartment of Neonatology, Emma Children's Hospital Academic Medical Centre (AMC), Amsterdam, The Netherlands.
C Aarnoudse-MoensDepartment of Neonatology, Emma Children's Hospital Academic Medical Centre (AMC), Amsterdam, The Netherlands.
C van de BeekDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction and Development Research Institute, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
D OepkesDepartment of Obstetrics and Gynaecology, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.
M C HaakDepartment of Obstetrics and Gynaecology, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.
M WoiskiDepartment of Obstetrics and Gynaecology, Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands.
M M PorathDepartment of Obstetrics and Gynaecology, Maxima Medical Centre (MMC), Veldhoven, The Netherlands.
J B DerksDepartment of Obstetrics and Gynaecology, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands.
Lem van KempenDepartment of Obstetrics and Gynaecology, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
T J RoseboomDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction and Development Research Institute, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
B W MolObstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.ORCID 0000-0001-8337-550X
E PajkrtDepartment of Obstetrics and Gynaecology, Academic Medical Centre (AMC), Amsterdam, The Netherlands.
Amsterdam UMC Location University of Amsterdam · NLLeiden University Medical Center · NLRadboud University Nijmegen · NLMaastricht University Medical Centre · NLMonash University · AUUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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 POPULATION: Follow up of infants of women who participated in the randomised controlled trial: PPROMEXIL-III (NTR3492).

methodsSurviving 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 measuresNeurodevelopmental 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.

resultsIn 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.

conclusionsIn 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.

Indexed as

Pregnancy Trimester, SecondAdultAge FactorsAmniotic FluidChild, PreschoolFemaleFollow-Up StudiesHumansInfusions, ParenteralMaleNeurodevelopmental DisordersPregnancyPremature Rupture of Fetal MembranesRespiratory Tract DiseasesSaline SolutionYoung AdultSaline SolutionFollow upinfant developmentneurodevelopmentoligohydramniossecond-trimester prelabour rupture of the membranes

Identifiers

PMID31984652
PMCPMC7818451
OpenAlexW3002446405

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.