Evidence map›Paper›PMID 19523680›Full record

SynthesisLancet (London, England)2009

Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis.

Jane E Norman, Fiona Mackenzie, Philip Owen, Helen Mactier, Kevin Hanretty, Sarah Cooper, Andrew Calder, Gary Mires, Peter Danielian, Stephen Sturgiss and 7 more

Registry-linked trialAbstract readMeta-AnalysisMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Synthesis in Lancet (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03058536 (Progesterone and Cervical Pessary in Twins), which is not on this map. Cited by 65 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 22 pooled it
–field-weighted citation impact
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.

NCT03058536 phase2 / phase3unknown statusnot on this mapstarted 2017, after this paper: background citation

Progesterone and Cervical Pessary in Twins : A Prospective and Randomized Study to Prevent Preterm Birth (PRECEPT)

TypeinterventionalSponsorMario Henrique Burlacchini de CarvalhoRan2017 to 2019Enrolled312ConditionsPreterm Birth, Twin Pregnancy With Antenatal ProblemArmsArabin Pessary, Vaginal Progesterone, Arabin Pessary and Progesterone
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 22 syntheses or guidelines pooled it.

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  10. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2017
    Pooled it
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  13. 17-Hydroxyprogesterone caproate in triplet pregnancy: an individual patient data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2016
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  19. Guidelines for the management of spontaneous preterm labor: identification of spontaneous preterm labor, diagnosis of preterm premature rupture of membranes, and preventive tools for preterm birth.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 · 2011
    Guideline
  20. Preterm birth.BMJ clinical evidence · 2011
    Pooled it

5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Jane E NormanReproductive and Developmental Sciences, University of Edinburgh, Edinburgh, UK. jane.norman@ed.ac.uk
Fiona Mackenzie
Philip Owen
Helen Mactier
Kevin Hanretty
Sarah Cooper
Andrew Calder
Gary Mires
Peter Danielian
Stephen Sturgiss
Graeme MacLennan
Graham Tydeman
Steven Thornton
Bill Martin
James G Thornton
James P Neilson
John Norrie

Funding

Chief Scientist Office CZH/4/200Chief Scientist Office HSRU1
6 · The paper itself

Abstract

backgroundWomen with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy.

methodsIn this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early (<34 weeks' gestation) preterm birth or intrauterine death in women with twin pregnancy. This study is registered, number ISRCTN35782581.

findingsThree participants in each group were lost to follow-up, leaving 247 analysed per group. The combined proportion of intrauterine death or delivery before 34 weeks of pregnancy was 24.7% (61/247) in the progesterone group and 19.4% (48/247) in the placebo group (odds ratio [OR] 1.36, 95% CI 0.89-2.09; p=0.16). The rate of adverse events did not differ between the two groups. The meta-analysis confirmed that progesterone does not prevent early preterm birth in women with twin pregnancy (pooled OR 1.16, 95% CI 0.89-1.51).

interpretationProgesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy.

fundingChief Scientist Office of the Scottish Government Health Directorate.

Indexed as

Pregnancy, MultipleTwinsAdministration, IntravaginalAdolescentAdultDelivery, ObstetricDouble-Blind MethodFemaleFetal DeathFollow-Up StudiesGelsHumansLikelihood FunctionsLinear ModelsLogistic ModelsMiddle AgedGelsProgesteroneProgestins

Identifiers

PMID19523680

What OpenQuestion holds

Textmetadata
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.