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Clinical trialNCT00135902CompletedPhase 3Interventional

Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies

SponsorThe George Washington University Biostatistics CenterEnrollment800Preterm Birth
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."

Investigators

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

  • Elizabeth A Thom, PhD

    George Washington University Biostatistics Center

    Principal Investigator
  • Margaret Harper, MD

    Wake Forest University Health Sciences

    Principal Investigator
  • Menachem Miodovnik, MD

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Principal Investigator

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

12 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

  • Drexel University

    Philadelphia, Pennsylvania, United States

  • University of Pittsburgh Magee Womens Hospital

    Pittsburgh, Pennsylvania, United States

  • Brown University

    Providence, Rhode Island, 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 Caproate and Omega-3 supplement17 alpha-hydroxy progesterone caproate and Placebo supplement
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
28 Feb 2005
Primary completion
31 Mar 2007
Completion
31 Mar 2008
Last update posted
12 Jul 2019
Registered enrollment
800
Registry id
NCT00135902

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.