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Clinical trialNCT00099164CompletedPhase 3Interventional

Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)

SponsorThe George Washington University Biostatistics CenterEnrollment795MultifetalPregnancyPreterm Birth
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo. The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama - Birmingham

    Birmingham, Alabama, United States

  • Northwestern University

    Chicago, Illinois, United States

  • Wayne State University

    Detroit, Michigan, United States

  • Columbia University

    New York, New York, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, United States

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, United States

  • Case Western University

    Cleveland, Ohio, United States

  • Ohio State University

    Columbus, Ohio, United States

  • Dexel University

    Philadelphia, Pennsylvania, United States

  • University of Pittsburgh Magee Womens Hospital

    Pittsburgh, Pennsylvania, United States

  • Brown University

    Providence, Rhode Island, United States

  • University of Texas - Southwest

    Dallas, Texas, United States

  • University of Texas - Houston

    Houston, Texas, United States

  • University of Utah Medical Center

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

17-alpha-hydroxyprogesterone
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2004
Primary completion
31 Aug 2006
Completion
30 Sept 2007
Last update posted
21 Feb 2019
Registered enrollment
795
Registry id
NCT00099164

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.