Evidence map›Paper›PMID 32124520›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2020

Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial.

Tms van Winden, J Klumper, C E Kleinrouweler, M A Tichelaar, C A Naaktgeboren, T A Nijman, A L van Baar, A G van Wassenaer-Leemhuis, T J Roseboom, J Van't Hooft and 4 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT07146451 (6-year Follow-up of Children Born to Mothers Exposed to Nifedipine vs Placebo After Preterm Prelabor Rupture of Membranes at 22 to 33 Weeks of Gestation), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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.

NCT07146451 recruitingnot on this mapstarted 2025, after this paper: background citation

6-year Follow-up of Children Born to Mothers Exposed to Nifedipine vs Placebo After Preterm Prelabor Rupture of Membranes at 22 to 33 Weeks of Gestation

TypeobservationalSponsorAssistance Publique - Hôpitaux de ParisRan2025 to 2034Enrolled480ConditionsChildren Born to Mothers Enrolled in the TOCOPROM TrialArmsSelf-administered parental questionnaire, A short psychological assessment performed online
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Long-term child outcomes after prenatal aspirin exposure: A 4-year follow-up of a randomized controlled trial (the APRIL study).International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Trial
  4. Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial.BJOG : an international journal of obstetrics and gynaecology · 2020
    Trial
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  13. Corrigendum.BJOG : an international journal of obstetrics and gynaecology · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Tms van WindenObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-5357-8872
J KlumperObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
C E KleinrouwelerObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
M A TichelaarObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
C A NaaktgeborenJulius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.ORCID 0000-0002-0685-9989
T A NijmanDepartment of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.ORCID 0000-0002-2620-8884
A L van BaarChild and Adolescent Studies, Utrecht University, Utrecht, the Netherlands.ORCID 0000-0002-3498-9019
A G van Wassenaer-LeemhuisPaediatrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-4414-9451
T J RoseboomObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
J Van't HooftObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0001-5303-1503
C RoosObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
B W MolDepartment of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.ORCID 0000-0001-8337-550X
E PajkrtObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-4432-3691
M A OudijkObstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0001-8672-4365
Amsterdam University Medical Centers · NLLeiden University · NLMonash University · AUUniversity Medical Center Utrecht · NLUtrecht University · NL

Funding

Illuminating the Role of understudied PRKACB Splice Variants in PKA SignalingR03TR002947 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TAYLOR, SUSAN S. · 2019 to 2019
$158k
NCATS NIH HHS R03 TR002947ZonMw 836011005ZonMw 836041012ZonMw NTR2947
6 · The paper itself

Abstract

objectiveTo compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years.

designThe APOSTEL III trial was a multicentre randomised controlled trial that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group.

methodsParents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems and general health.

main outcome measuresThe main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years.

resultsOf the 426 women eligible for follow-up, 196 (46%) parents returned the questionnaires for 115 children in the nifedipine group and 110 children in the atosiban group. Abnormal development occurred in 32 children (30%) in the nifedipine group and in 38 children (38%) in the atosiban group (OR 0.74, 95% CI 0.41-1.34). The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups. Sensitivity analysis for all children of the APOSTEL III trial, including a comparison of deceased children, resulted in a higher rate of healthy survival in the nifedipine group (64 versus 54%), but there was no significant difference in the overall mortality rate (5.4 versus 2.7%). There were no significant subgroup effects.

conclusionOutcomes on broad child neurodevelopment, executive function, behaviour and general health were comparable in both groups. Neither nifedipine nor atosiban can be considered as the preferred treatment for women with threatened preterm birth. TWEETABLE ABSTRACT: Nifedipine- and atosiban-exposed children had comparable long-term outcomes, including neurodevelopment, executive function and behaviour.

Indexed as

Child Behavior DisordersChild, PreschoolExecutive FunctionFemaleFollow-Up StudiesHealth StatusHumansMaleNeurodevelopmental DisordersNifedipinePregnancyPremature BirthSurveys and QuestionnairesTocolysisTocolytic AgentsVasotocinatosibanNifedipineTocolytic AgentsVasotocinAtosibanbehaviourchilddevelopmentexecutive functionfollow-uphealthinfantneurodevelopmentnifedipinepreterm birthpreterm labourtocolysis

Identifiers

PMID32124520
PMCPMC7384124
OpenAlexW3009913995

What OpenQuestion holds

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LicenceCC BY
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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.