Evidence map›Paper›PMID 19155896›Full record

Trial reportObstetrics and gynecology2009

Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.

Steve N Caritis, Dwight J Rouse, Alan M Peaceman, Anthony Sciscione, Valerija Momirova, Catherine Y Spong, Jay D Iams, Ronald J Wapner, Michael Varner, Marshall Carpenter and 8 more

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 7 pooled it
11.1field-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.

NCT00099164 phase3completednot on this map

A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Multifetal Gestation (STTARS)

TypeinterventionalSponsorThe George Washington University Biostatistics CenterRan2004 to 2007Enrolled795ConditionsPreterm Birth, Pregnancy, MultifetalArms17 alpha-hydroxyprogesterone caproate (17P)
NCT01119963 phase2 / phase3completednot on this mapstarted 2011, after this paper: background citation

17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial

TypeinterventionalSponsorObstetrix Medical GroupRan2011 to 2014Enrolled152ConditionsPreterm DeliveryArms17-alpha-hydroxy-progesterone caproate, Makena®, Castor Oil (Placebo)
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 7 syntheses or guidelines pooled it, 128 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. 17-Hydroxyprogesterone caproate in triplet pregnancy: an individual patient data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2016
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Preterm birth.BMJ clinical evidence · 2011
    Pooled it
  8. Trial
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Pharmacogenomics of preterm birth prevention and treatment.BJOG : an international journal of obstetrics and gynaecology · 2016
    Review
  17. Review
  18. Review
  19. Article
  20. Progesterone to prevent preterm birth in twin gestations: what is the next step forward?BJOG : an international journal of obstetrics and gynaecology · 2013
    Article
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

18 authors at 5 institutions in 1 country.

Steve N CaritisDepartments of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA 15213, USA. scaritis@mail.magee.edu
Dwight J Rouse
Alan M Peaceman
Anthony Sciscione
Valerija Momirova
Catherine Y Spong
Jay D Iams
Ronald J Wapner
Michael Varner
Marshall Carpenter
Julie Lo
John Thorp
Brian M Mercer
Yoram Sorokin
Margaret Harper
Susan Ramin
Garland Anderson
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Maternal-Fetal Medicine Units Network (MFMU)
Brown University · USNorthwestern University · USThe University of Texas Southwestern Medical Center · USWake Forest University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · US

Funding

Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research NetU10HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI CLIFTON, REBECCA GERSNOVIEZ · 2009 to 2021
$174.2M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
SARS-CoV-2 Vaccine Pregnancy RegistryU24HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI Rebecca Gersnoviez Clifton · 2021 to 2026
$39.2M
MATERNAL FETAL RESEARCH NETWORK: DATA COORDINATING CTRU01HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI THOM, ELIZABETH ANN · 1998 to 2008
$27.0M
NICHD Maternal Fetal Medicine Units NetworkU10HD034116 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI CASEY, BRIAN M · 1996 to 2015
$19.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD034208 · NICHD · UNIVERSITY OF UTAH · PI VARNER, MICHAEL W. · 1996 to 2015
$16.6M
NICHD Maternal Fetal Medicine Units NetworkU10HD027869 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 1991 to 2015
$12.8M
NICHD Maternal Fetal Medicine Units NetworkU10HD040485 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WAPNER, RONALD · 2001 to 2015
$12.5M
NICHD Maternal Fetal Medicine Units NetworkU10HD040560 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI THORP, JOHN M · 2001 to 2015
$10.3M
Carolina Population CenterR24HD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MORGAN, SAMUEL PHILIP · 2005 to 2014
$10.0M
NICHD Maternal Fetal Medicine Units NetworkU10HD040512 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GROBMAN, WILLIAM ADAM · 2001 to 2015
$8.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD027917 · NICHD · WAYNE STATE UNIVERSITY · PI GONIK, BERNARD · 1991 to 2015
$8.2M
NCATS NIH HHS UL1 TR000005NICHD NIH HHS HD21410NICHD NIH HHS HD27860NICHD NIH HHS HD27869NICHD NIH HHS HD27915NICHD NIH HHS HD27917NICHD NIH HHS HD34116NICHD NIH HHS HD34136NICHD NIH HHS HD34208NICHD NIH HHS HD36801NICHD NIH HHS HD40485NICHD NIH HHS HD40500NICHD NIH HHS HD40512NICHD NIH HHS HD40544NICHD NIH HHS HD40545NICHD NIH HHS HD40560NICHD NIH HHS HD53097NICHD NIH HHS R24 HD050924NICHD NIH HHS U01 HD036801NICHD NIH HHS U10 HD021410NICHD NIH HHS U10 HD027860NICHD NIH HHS U10 HD027869NICHD NIH HHS U10 HD027915NICHD NIH HHS U10 HD027917NICHD NIH HHS U10 HD034116NICHD NIH HHS U10 HD034136NICHD NIH HHS U10 HD034208NICHD NIH HHS U10 HD036801NICHD NIH HHS U10 HD040485NICHD NIH HHS U10 HD040500NICHD NIH HHS U10 HD040512NICHD NIH HHS U10 HD040544NICHD NIH HHS U10 HD040545NICHD NIH HHS U10 HD040560NICHD NIH HHS U10 HD053097NICHD NIH HHS U24 HD036801NICHD NIH HHS UG1 HD027869NICHD NIH HHS UG1 HD027915NICHD NIH HHS UG1 HD034116NICHD NIH HHS UG1 HD034208NICHD NIH HHS UG1 HD040485NICHD NIH HHS UG1 HD040500NICHD NIH HHS UG1 HD040512NICHD NIH HHS UG1 HD040544NICHD NIH HHS UG1 HD040545NICHD NIH HHS UG1 HD040560NICHD NIH HHS UG1 HD053097
6 · The paper itself

Abstract

objectiveTo assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets.

methodsWe performed this randomized, double-blinded, placebo-controlled trial in 14 centers. Healthy women with triplets were randomly assigned to weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo, starting at 16-20 weeks and ending at delivery or 35 weeks of gestation. The primary study outcome was delivery or fetal loss before 35 weeks.

resultsOne hundred thirty-four women were assigned, 71 to 17 alpha-hydroxyprogesterone caproate and 63 to placebo; none were lost to follow-up. Baseline demographic data were similar in the two groups. The proportion of women experiencing the primary outcome (a composite of delivery or fetal loss before 35 0/7 weeks) was similar in the two treatment groups: 83% of pregnancies in the 17 alpha-hydroxyprogesterone caproate group and 84% in the placebo group, relative risk 1.0, 95% confidence interval 0.9-1.1. The lack of benefit of 17 alpha-hydroxyprogesterone caproate was evident regardless of the conception method or whether a gestational age cutoff for delivery was set at 32 or 28 weeks.

conclusionTreatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with triplet gestations. CLINICAL

trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00099164 LEVEL OF EVIDENCE: I.

Indexed as

17 alpha-Hydroxyprogesterone CaproateAdultFemaleHumansHydroxyprogesteronesInjections, IntramuscularPregnancyPremature BirthProgestinsRiskTreatment FailureTriplets17 alpha-Hydroxyprogesterone CaproateHydroxyprogesteronesProgestins

Identifiers

PMID19155896
PMCPMC2790283
OpenAlexW103436252

What OpenQuestion holds

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LicenceTDM
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.