Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
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ClinicalTrials.gov Identifier: NCT00135902 |
Recruitment Status
:
Completed
First Posted
: August 26, 2005
Last Update Posted
: October 3, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preterm Birth | Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 fish oils | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 800 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2008 |

- Delivery less than 37 completed weeks gestation including any miscarriages occurring after randomization
- MATERNAL: Delivery less than 35 weeks
- Delivery less than 32 weeks
- Spontaneous preterm delivery
- Indicated preterm delivery
- Tocolytic therapy
- Time from randomization to delivery
- Delivery on or after 41 weeks of gestation
- Occurrence of gestational hypertension or preeclampsia
- Maternal hospital days
- Fatty acid constituents in maternal plasma samples, before and after supplementation
- Postpartum hemorrhage
- FETAL AND NEONATAL: Fetal and neonatal death
- Gestational age at delivery
- Small for gestational age
- Birth weight
- Apgar score at 1 and 5 minutes
- Number of days of neonatal respiratory therapy
- Admission to NICU and total number of days in hospital
- Intraventricular hemorrhage
- Retinopathy of prematurity
- Necrotizing enterocolitis
- Deep infection
- Periventricular leukomalacia
- Bronchopulmonary dysplasia
- Respiratory distress syndrome
- Composite neonatal outcome

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Documented history of previous singleton spontaneous birth
- Singleton pregnancy
- Gestational age at randomization between 16 and 22 weeks
Exclusion Criteria:
- Major fetal anomaly or demise
- Regular intake of fish oil supplements
- Daily use of nonsteroidal anti-inflammatory agents
- Allergy to fish or fish products
- Gluten intolerant
- Heparin use or known thrombophilia
- Hemophilia
- Planned termination
- Current hypertension or current use of antihypertensive medications
- Type D, F or R diabetes
- Maternal medical complications
- Current or planned cerclage
- Illicit drug or alcohol abuse during current pregnancy
- Delivery at a non-Network hospital
- Participation in another pregnancy intervention study
- Participation in this trial in a previous pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135902
United States, Alabama | |
University of Alabama - Birmingham | |
Birmingham, Alabama, United States | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States | |
United States, New York | |
Columbia University | |
New York, New York, United States | |
United States, North Carolina | |
University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States | |
Wake Forest University School of Medicine | |
Winston Salem, North Carolina, United States | |
United States, Ohio | |
Case Western University | |
Cleveland, Ohio, United States | |
Ohio State University | |
Columbus, Ohio, United States | |
United States, Pennsylvania | |
Drexel University | |
Philadelphia, Pennsylvania, United States | |
University of Pittsburgh Magee Womens Hospital | |
Pittsburgh, Pennsylvania, United States | |
United States, Rhode Island | |
Brown University | |
Providence, Rhode Island, United States | |
United States, Texas | |
University of Texas - Southwest | |
Dallas, Texas, United States | |
United States, Utah | |
University of Utah Medical Center | |
Salt Lake City, Utah, United States |
Principal Investigator: | Uma Reddy, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |
Principal Investigator: | Elizabeth A Thom, PhD | George Washington University Biostatistics Center | |
Principal Investigator: | Margaret Harper, MD | Wake Forest University Health Sciences |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The George Washington University Biostatistics Center |
ClinicalTrials.gov Identifier: | NCT00135902 History of Changes |
Other Study ID Numbers: |
HD36801-Omega-3 HD21410 HD27869 HD27917 HD27860 HD27915 HD34116 HD34208 HD34136 HD40500 HD40485 HD40544 HD40545 HD40560 HD40512 |
First Posted: | August 26, 2005 Key Record Dates |
Last Update Posted: | October 3, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data will be shared after completion and publication of the main analyses in accordance with NIH policy. The contact to obtain datasets is mfmudatasets@bsc.gwu.edu. |
Keywords provided by The George Washington University Biostatistics Center:
Preterm birth Progesterone Omega-3 fatty acid Pregnancy |
Additional relevant MeSH terms:
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications 17-alpha-hydroxy-progesterone caproate 11-hydroxyprogesterone |
Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Progestins Hormones |