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Completed Phase 3 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT00099164

Public ClinicalTrials.gov record NCT00099164. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00099164
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
795 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2004 (Type not available)
Primary completion
Aug 2006 (Actual)
Completion
Sep 2007 (Actual)
Last update posted
Feb 21, 2019

2004 – 2007

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
University of Alabama - Birmingham Birmingham Alabama 35233 —
Northwestern University Chicago Illinois 60611 —
Wayne State University Detroit Michigan 48201 —
Columbia University New York New York 10032 —
University of North Carolina - Chapel Hill Chapel Hill North Carolina 27599 —
Wake Forest University School of Medicine Winston-Salem North Carolina 27157 —
Case Western University Cleveland Ohio 44109 —
Ohio State University Columbus Ohio 43210 —
Dexel University Philadelphia Pennsylvania 19107 —
University of Pittsburgh Magee Womens Hospital Pittsburgh Pennsylvania 15213 —
Brown University Providence Rhode Island 02905 —
University of Texas - Southwest Dallas Texas 75235 —
University of Texas - Houston Houston Texas 77030 —
University of Utah Medical Center Salt Lake City Utah 84132 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00099164, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 21, 2019 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00099164 live on ClinicalTrials.gov.

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