Evidence map›Paper›PMID 17671253›Full record

Trial reportThe New England journal of medicine2007

A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins.

Dwight J Rouse, Steve N Caritis, Alan M Peaceman, Anthony Sciscione, Elizabeth A Thom, Catherine Y Spong, Michael Varner, Fergal Malone, Jay D Iams, Brian M Mercer and 8 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2007. 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 71 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 13 pooled it
17.6field-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)
NCT02490384 naterminatednot on this mapstarted 2015, after this paper: background citation

Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations

TypeinterventionalSponsorThomas Jefferson UniversityRan2015 to 2019Enrolled30ConditionsTwin Pregnancy, Antepartum Condition or Complication, Preterm Birth, Cervical Dilation PrematureArmsPhysical exam indicated cerclage
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 13 syntheses or guidelines pooled it, 371 citations in OpenAlex.

  1. Pooled it
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  6. 17-Hydroxyprogesterone caproate in triplet pregnancy: an individual patient data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2016
    Pooled it
  7. Pooled it
  8. Pooled it
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  12. 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
  13. Progesterone for preventing pre-eclampsia and its complications.The Cochrane database of systematic reviews · 2006
    Pooled it
  14. Trial
  15. Accuracy of sonographic chorionicity classification in twin gestations.Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine · 2014
    Trial
  16. Trial
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  19. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2011
    Trial
  20. Second trimester cervical length and risk of preterm birth in women with twin gestations treated with 17-α hydroxyprogesterone caproate.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 · 2010
    Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 16 institutions in 2 countries.

Dwight J RouseDepartment of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham 35249-7333, USA. drouse@uab.edu
Steve N Caritis
Alan M Peaceman
Anthony Sciscione
Elizabeth A Thom
Catherine Y Spong
Michael Varner
Fergal Malone
Jay D Iams
Brian M Mercer
John Thorp
Yoram Sorokin
Marshall Carpenter
Julie Lo
Susan Ramin
Margaret Harper
Garland Anderson
National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
Brown University · USCase Western Reserve University · USColumbia University · USDrexel University · USGeorge Washington University · USNorthwestern University · PHThe Ohio State University · USThe University of Texas Health Science Center at Houston · USThe University of Texas Medical Branch at Galveston · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of North Carolina at Chapel Hill · USUniversity of Pittsburgh · USUniversity of Utah · USWake Forest University · USWayne State University · 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
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
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
NICHD Maternal Fetal Medicine Units NetworkU10HD027915 · NICHD · OHIO STATE UNIVERSITY · PI IAMS, JAY · 1992 to 2015
$7.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040545 · NICHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI CHAUHAN, SUNEET P · 2001 to 2015
$7.7M
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 HD40560
6 · The paper itself

Abstract

backgroundIn singleton gestations, 17 alpha-hydroxyprogesterone caproate (17P) has been shown to reduce the rate of recurrent preterm birth. This study was undertaken to evaluate whether 17P would reduce the rate of preterm birth in twin gestations.

methodsWe performed a randomized, double-blind, placebo-controlled trial in 14 centers. Healthy women with twin gestations were assigned to weekly intramuscular injections of 250 mg of 17P or matching placebo, starting at 16 to 20 weeks of gestation and ending at 35 weeks. The primary study outcome was delivery or fetal death before 35 weeks of gestation.

resultsSix hundred sixty-one women were randomly assigned to treatment. Baseline demographic data were similar in the two study groups. Six women were lost to follow-up; data from 655 were analyzed (325 in the 17P group and 330 in the placebo group). Delivery or fetal death before 35 weeks occurred in 41.5% of pregnancies in the 17P group and 37.3% of those in the placebo group (relative risk, 1.1; 95% confidence interval [CI], 0.9 to 1.3). The rate of the prespecified composite outcome of serious adverse fetal or neonatal events was 20.2% in the 17P group and 18.0% in the placebo group (relative risk, 1.1; 95% CI, 0.9 to 1.5). Side effects of the injections were frequent in both groups, occurring in 65.9% and 64.4% of subjects, respectively (P=0.69), but were generally mild and limited to the injection site.

conclusionsTreatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with twin gestations. (ClinicalTrials.gov number, NCT00099164 [ClinicalTrials.gov].).

Indexed as

Pregnancy, MultipleTwins17 alpha-Hydroxyprogesterone CaproateAdultDouble-Blind MethodFemaleHumansHydroxyprogesteronesInjections, IntramuscularPregnancyPregnancy OutcomePremature BirthProgesterone CongenersTreatment Failure17 alpha-Hydroxyprogesterone CaproateHydroxyprogesteronesProgesterone Congeners

Identifiers

PMID17671253
OpenAlexW2055316985

What OpenQuestion holds

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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.