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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135902
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : April 10, 2019
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

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."

Condition or disease Intervention/treatment Phase
Preterm Birth Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 fish oils Phase 3

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.

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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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Delivery less than 37 completed weeks gestation including any miscarriages occurring after randomization

Secondary Outcome Measures :
  1. MATERNAL: Delivery less than 35 weeks
  2. Delivery less than 32 weeks
  3. Spontaneous preterm delivery
  4. Indicated preterm delivery
  5. Tocolytic therapy
  6. Time from randomization to delivery
  7. Delivery on or after 41 weeks of gestation
  8. Occurrence of gestational hypertension or preeclampsia
  9. Maternal hospital days
  10. Fatty acid constituents in maternal plasma samples, before and after supplementation
  11. Postpartum hemorrhage
  12. FETAL AND NEONATAL: Fetal and neonatal death
  13. Gestational age at delivery
  14. Small for gestational age
  15. Birth weight
  16. Apgar score at 1 and 5 minutes
  17. Number of days of neonatal respiratory therapy
  18. Admission to NICU and total number of days in hospital
  19. Intraventricular hemorrhage
  20. Retinopathy of prematurity
  21. Necrotizing enterocolitis
  22. Deep infection
  23. Periventricular leukomalacia
  24. Bronchopulmonary dysplasia
  25. Respiratory distress syndrome
  26. Composite neonatal outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00135902

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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
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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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 of Results:
Other Publications:
Duley L. Prophylactic fish oil in pregnancy. The Cochrane Pregnancy & Childbirth Database (Issue 2, 1995).

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: The George Washington University Biostatistics Center Identifier: NCT00135902     History of Changes
Other Study ID Numbers: HD36801-Omega-3
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
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

Keywords provided by The George Washington University Biostatistics Center:
Preterm birth
Omega-3 fatty acid

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17 alpha-Hydroxyprogesterone Caproate
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs