Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT00135902
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2005-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
Sponsor:
The George Washington University Biostatistics Center
Organization:
Study Overview
Official Title:
A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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."
Detailed Description:
Preterm birth is the leading cause of perinatal mortality and morbidity. In a recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P), the National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network found the treatments significantly beneficial in the prevention of recurrent preterm birth. Other studies have shown that fish oil supplementation can reduce the risk for preterm birth. The purpose of this study is to determine whether Omega-3, a polyunsaturated fatty acid nutritional supplement, in addition to injections of 17P, further decreases the rate of preterm birth in women at risk.
This study is a randomized, double-masked clinical trial with two study arms: a daily supplement of Omega-3 capsules containing 800 mg of DHA and 1200 mg of EPA or a daily supplement of a matching placebo. All patients will also receive weekly injections of 17P. Eight hundred pregnant women with a history of previous preterm delivery will be recruited for this study. After successfully completing a compliance run-in, which can begin as early as 15 weeks gestation, patients will be randomized and begin treatment between 16 and 22 weeks gestation. They will remain on study drug until 36 week and 6 days or delivery, whichever occurs first. Blood will be drawn at randomization and at a monthly visit falling between 25-29 weeks of gestation to test for compliance, to analyze genetic polymorphisms and to determine whether Omega-3 affects the production of inflammatory cytokines.
This study is a randomized, double-masked clinical trial with two study arms: a daily supplement of Omega-3 capsules containing 800 mg of DHA and 1200 mg of EPA or a daily supplement of a matching placebo. All patients will also receive weekly injections of 17P. Eight hundred pregnant women with a history of previous preterm delivery will be recruited for this study. After successfully completing a compliance run-in, which can begin as early as 15 weeks gestation, patients will be randomized and begin treatment between 16 and 22 weeks gestation. They will remain on study drug until 36 week and 6 days or delivery, whichever occurs first. Blood will be drawn at randomization and at a monthly visit falling between 25-29 weeks of gestation to test for compliance, to analyze genetic polymorphisms and to determine whether Omega-3 affects the production of inflammatory cytokines.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10HD021410 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027869 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027917 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027860 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD027915 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD034208 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD034136 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040500 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040485 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040544 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040545 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040560 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD040512 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10HD036801 | NIH | None | https://reporter.nih.gov/quic… | View |