Evidence map›Paper›PMID 22545024›Full record

Trial reportPLoS medicine2012

Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial.

David P van der Ham, Sylvia M C Vijgen, Jan G Nijhuis, Johannes J van Beek, Brent C Opmeer, Antonius L M Mulder, Rob Moonen, Mariët Groenewout, Mariëlle G van Pampus, Gerald D Mantel and 17 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03213535 (Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
10.1field-weighted citation impact, top 1% 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.

NCT03213535 unknown statusnot on this mapstarted 2017, after this paper: background citation

Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture

Typeobservational_patient_registrySponsorAin Shams UniversityRan2017 to 2017Enrolled60ConditionsRupture of Membranes, Premature
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 203 citations in OpenAlex.

  1. Pooled it
  2. Use of labour induction and risk of cesarean delivery: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2014
    Pooled it
  3. Trial
  4. Review
  5. Effect of gestational age on special education: a population-based matched cohort analysis.Archives of disease in childhood. Fetal and neonatal edition · 2025
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Expectant management of preterm premature rupture of membranes at 34 weeks: a cost effectiveness analysis.The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians · 2022
    Article
  12. Article
  13. Observational
  14. Article
  15. Article
  16. Perinatal Outcomes Associated with Latency in Late Preterm Premature Rupture of Membranes.International journal of environmental research and public health · 2021
    Article
  17. Article
  18. Predictors of Caesarean Delivery in Preterm Premature Rupture of Membranes.Open access Macedonian journal of medical sciences · 2019
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 1 country.

David P van der HamDepartment of Obstetrics and Gynecology, Maastricht University Medical Center, GROW-School for Oncology and Developmental Biology, Maastricht, The Netherlands. dpvanderham@gmail.com
Sylvia M C Vijgen
Jan G Nijhuis
Johannes J van Beek
Brent C Opmeer
Antonius L M Mulder
Rob Moonen
Mariët Groenewout
Mariëlle G van Pampus
Gerald D Mantel
Kitty W M Bloemenkamp
Wim J van Wijngaarden
Marko Sikkema
Monique C Haak
Paula J M Pernet
Martina Porath
Jan F M Molkenboer
Simone Kuppens
Anneke Kwee
Michael E Kars
Mallory Woiski
Martin J N Weinans
Hajo I J Wildschut
Bettina M C Akerboom
Ben W J Mol
Christine Willekes
PPROMEXIL trial group
Academic Medical Center · NLMaastricht University · NLUniversity Medical Center Groningen · NLAlbert Schweitzer Ziekenhuis · NLAmsterdam UMC Location VUmc · NLAtrium Medisch Centrum Parkstad · NLBronovo Hospital · NLCatharina Ziekenhuis · NLErasmus MC · NLIsala · NLLeiden University Medical Center · NLMaastro Clinic · NLMáxima Medisch Centrum · NLRadboud University Medical Center · NLSpaarne Gasthuis · NLSt. Anna Ziekenhuis · NLSt. Antonius Ziekenhuis · NLUniversity Medical Center Utrecht · NLVieCuri Medisch Centrum · NLZiekenhuis Gelderse Vallei · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAt present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term. METHODS AND

findingsWe conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34(+0) and 37(+0) wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM.

conclusionsIn women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM.

trial registrationCurrent Controlled Trials ISRCTN29313500

Indexed as

Labor, InducedLabor, ObstetricPregnancy Complications, InfectiousPregnancy OutcomePremature Rupture of Fetal MembranesAdolescentAdultCesarean SectionChorioamnionitisFemaleFetusGestational AgeHumansInfant, NewbornInfant, Newborn, DiseasesMiddle Aged

Identifiers

PMID22545024
PMCPMC3335867
OpenAlexW2104371880

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.