Evidence map›Paper›PMID 31032879›Full record

Trial reportActa obstetricia et gynecologica Scandinavica2019

Child outcomes after placement of a cervical pessary in women with a multiple pregnancy: A 4-year follow-up of the ProTWIN trial.

Noor E Simons, Cornelieke van de Beek, Johanna H van der Lee, Brent C Opmeer, Aleid G van Wassenaer-Leemhuis, Anneloes L van Baar, Leonie Steenis, Sophie Liem, Ewoud Schuit, Dick Bekedam and 2 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Acta obstetricia et gynecologica Scandinavica, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 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
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  5. Consequences of cervical pessary for subsequent pregnancy: follow-up of randomized clinical trial (ProTWIN).Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2022
    Trial
  6. Progesterone for prevention of preterm birth in women with short cervical length: 2-year infant outcomes.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2021
    Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 2 countries.

Noor E SimonsDepartment of Obstetrics and Gynecology, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.ORCID 0000-0002-9109-0800
Cornelieke van de BeekDepartment of Obstetrics and Gynecology, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Johanna H van der LeePediatric Clinical Research Office, Emma Children's Hospital Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Brent C OpmeerClinical Research Unit, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Aleid G van Wassenaer-LeemhuisDepartment of Neonatology and Pediatrics, Emma Children's Hospital Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Anneloes L van BaarUtrecht University, Utrecht, The Netherlands.
Leonie SteenisJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Sophie LiemDepartment of Obstetrics and Gynecology, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Ewoud SchuitJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Dick BekedamDepartment of Obstetrics and Gynecology, OLVG-Oost, Amsterdam, The Netherlands.
Ben W J MolDepartment of Obstetrics and Gynecology, Monash University, Melbourne, Victoria, Australia.
Janneke Van't HooftDepartment of Obstetrics and Gynecology, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Amsterdam University Medical Centers · NLEmma Kinderziekenhuis · NLUniversity Medical Center Utrecht · NLGGZ Oost Brabant · NLMonash University · AUUtrecht University · NL

Funding

Academic Medical CenterNetherlands Trial Registry NTR1858NHMRC Practitioner Fellowship GNT1082548ZonMW 20031004
6 · The paper itself

Abstract

introductionThe ProTWIN trial previously showed no beneficial effect of treatment with a cervical pessary vs usual care to prevent preterm birth in women with a multiple pregnancy. However, in women with a midtrimester short cervix (<38 mm), pessary did reduce the composite outcome of neonatal morbidity and mortality. This follow-up study evaluates the long-term outcomes of all children born to mothers who participated in the ProTWIN trial at 4 years of age. MATERIAL AND

methodsParents received the Ages and Stages Questionnaire, Strength and Difficulties Questionnaire and a health questionnaire. All questionnaires were reported separately and as a combined outcome (abnormal child outcome). A linear mixed effects model was used to adjust for correlated data in twins and correction for confounders was performed. In exploratory analysis, a composite outcome of death or survival with abnormal child outcome was used by combining extrapolated data on child outcome with survival data. All data were analyzed for the total group and the subgroup of women with midtrimester short cervix.

resultsOf the original 813 women of the ProTWIN trial, we approached 579, of whom 258 participated (45%) in follow-up. We received questionnaires of 514 children (281 pessary vs 233 control), with 119 children in the subgroup of women with midtrimester short cervix. An abnormal child outcome was found in 23% in the pessary group vs 16% in the control group (odds ratio 1.58; 95% confidence interval 0.94-2.65). In exploratory analysis with extrapolated data on child outcome (n = 815), no difference in abnormal child outcome was seen between the pessary and control group. In the subgroup of women with a short cervix (n = 268), this composite outcome indicated a favorable outcome for children born to mothers with pessary.

conclusionsIn women with a multiple pregnancy, the use of a cervical pessary did not improve development, behavior or physical outcomes of the surviving children at age 4.

Indexed as

Cervix UteriPessariesPregnancy, MultipleAdultCervical Length MeasurementChild, PreschoolFemaleFollow-Up StudiesHumansInfantInfant, NewbornPregnancyPregnancy OutcomePremature BirthSurveys and Questionnairesbehaviorchilddevelopmentfollow-upmultiple pregnancypessarypreterm birth

Identifiers

PMID31032879
PMCPMC6900136
OpenAlexW2943628795

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.