Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
Public ClinicalTrials.gov record NCT00135902. 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.
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 Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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."
Study identification
- NCT ID
- NCT00135902
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 800 participants
Conditions and interventions
Conditions
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
- Jan 31, 2005
- Primary completion
- Feb 28, 2007
- Completion
- Feb 29, 2008
- Last update posted
- Jul 11, 2019
2005 – 2008
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | — | — |
| Northwestern University | Chicago | Illinois | — | — |
| Wayne State University | Detroit | Michigan | — | — |
| Columbia University | New York | New York | — | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | — | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | — | — |
| Case Western University | Cleveland | Ohio | — | — |
| Ohio State University | Columbus | Ohio | — | — |
| Drexel University | Philadelphia | Pennsylvania | — | — |
| University of Pittsburgh Magee Womens Hospital | Pittsburgh | Pennsylvania | — | — |
| Brown University | Providence | Rhode Island | — | — |
| University of Utah Medical Center | Salt Lake City | Utah | — | — |
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 NCT00135902, 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 Jul 11, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00135902 live on ClinicalTrials.gov.