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NCT00135902 · ClinicalTrials.gov registry record · Phase 3
Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
NCT00135902: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.
NCT00135902 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 800 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135902, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
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."
Primary Outcome
Delivery before 37 weeks including any miscarriages occurring after randomization
Interventions
- DRUG 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement
- DRUG 17 alpha-hydroxy progesterone caproate and Placebo supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00135902 record still lists
NCT00135902 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement is the first listed.
NCT00135902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135902 about?
NCT00135902 is a clinical study titled "Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies". 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 diet...
What is the current status of trial NCT00135902?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2005-02. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00135902?
The interventions under investigation include: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement (DRUG), 17 alpha-hydroxy progesterone caproate and Placebo supplement (DRUG).
Who is sponsoring clinical trial NCT00135902?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135902's enrollment target sits among peer trials
800 414th of 2000 higher than 1,573 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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