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

NCT00135902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2019-07-12

No results posted yet for this study

Summary

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."

Conditions

Interventions

DRUG

17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement

Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.

DRUG

17 alpha-hydroxy progesterone caproate and Placebo supplement

Participants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements

Sponsors & Collaborators

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

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Menachem Miodovnik, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Elizabeth A Thom, PhD · George Washington University Biostatistics Center

  • Margaret Harper, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00135902 on ClinicalTrials.gov