Evidence map›Paper›PMID 12592250›Full record

Trial reportAmerican journal of obstetrics and gynecology2003

Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study.

Eduardo B da Fonseca, Roberto E Bittar, Mario H B Carvalho, Marcelo Zugaib

6 registry-linked trialsAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 147 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
147citing papers in PubMed, 18 pooled it
21.7field-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.

NCT00086177 phase3completednot on this mapstarted 2004, after this paper: background citation

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy, Safety, and Tolerability of 8% Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery

TypeinterventionalSponsorJuniper Pharmaceuticals, Inc.Ran2004 to 2009Enrolled636ConditionsPregnancyArms8% progesterone vaginal gel, Placebo Vaginal Gel
NCT00120640 nawithdrawnnot on this mapstarted 2005, after this paper: background citation

Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate

TypeinterventionalSponsorYale UniversityRan2005Enrolled0ConditionsPremature Birth, Premature LaborArms17 hydroxyprogesterone caproate intramuscular injections
NCT00163020 phase2 / phase3completednot on this mapstarted 2004, after this paper: background citation

17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity Due to Preterm Birth in Twin and Triplet Pregnancies - A Concurrent Randomized Double-blinded Clinical Trial

TypeinterventionalSponsorObstetrix Medical GroupRan2004 to 2009Enrolled321ConditionsPreterm BirthArms17-alpha-hydroxyprogesterone caproate injectable, Placebo
NCT00409825 phase2completednot on this mapstarted 2006, after this paper: background citation

A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy

TypeinterventionalSponsorUniversity of PittsburghRan2006 to 2014Enrolled61ConditionsPregnancyArms17-OHPC, Blood Draws
NCT02901626 phase3terminatednot on this mapstarted 2017, after this paper: background citation

A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix

TypeinterventionalSponsorThe George Washington University Biostatistics CenterRan2017 to 2022Enrolled544ConditionsShort Cervix, Preterm DeliveryArmsArabin Cervical Pessary
NCT03202836 nacompletednot on this mapstarted 2017, after this paper: background citation

Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial

TypeinterventionalSponsorChulalongkorn UniversityRan2017 to 2018Enrolled90ConditionsPreterm LaborArmsprogesterone, Tocolytics, Steroids
3 · Its place in the literature

Who cites it

147 citing papers in PubMed, 18 syntheses or guidelines pooled it, 792 citations in OpenAlex.

  1. Pooled it
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  7. Vaginal progesterone decreases preterm birth ≤ 34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2016
    Pooled it
  8. 17-Hydroxyprogesterone caproate in triplet pregnancy: an individual patient data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2016
    Pooled it
  9. A systematic review and meta-analysis of progestogen use for maintenance tocolysis after preterm labor in women with intact membranes.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2016
    Pooled it
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  11. Progestational agents for treating threatened or established preterm labour.The Cochrane database of systematic reviews · 2014
    Pooled it
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  17. 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
  18. Pooled it
  19. Trial
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87 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Eduardo B da FonsecaObstetrics Clinic, University of São Paulo Medical School, Brazil. riedu@uol.com.br
Roberto E Bittar
Mario H B Carvalho
Marcelo Zugaib
Universidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe purpose of this study was to evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate in a high-risk population. STUDY

designA randomized, double-blind, placebo-controlled study included 142 high-risk singleton pregnancies. Progesterone (100 mg) or placebo was administered daily by vaginal suppository and all patients underwent uterine contraction monitoring with an external tocodynamometer once a week for 60 minutes, between 24 and 34 weeks of gestation. Progesterone (n = 72) and placebo (n = 70) groups were compared for epidemiologic characteristics, uterine contraction frequency, and incidence of preterm birth. Data were compared by chi(2) analysis and Fisher exact test.

resultsThe preterm birth rate was 21.1% (30/142). Differences in uterine activity were found between the progesterone and placebo groups (23.6% vs 54.3%, respectively; P <.05) and in preterm birth between progesterone and placebo (13.8% vs 28.5%, respectively; P <.05). More women were delivered before 34 weeks in the placebo group (18.5%) than in the progesterone group (2.7%) (P <.05).

conclusionProphylactic vaginal progesterone reduced the frequency of uterine contractions and the rate of preterm delivery in women at high risk for prematurity.

Indexed as

AdultBirth RateDouble-Blind MethodFemaleHumansObstetric Labor, PrematurePlacebosPregnancyProgesteroneRisk FactorsSuppositoriesUterine ContractionPlacebosProgesteroneSuppositories

Identifiers

PMID12592250
OpenAlexW2075719860

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.