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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 : July 12, 2019
Sponsor:
Collaborator:
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 supplement Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplement 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


Arm Intervention/treatment
Active Comparator: 17P plus Omega-3 Supplement
Weekly 17 alpa hydroxyprogesterone caproate (17p) injections plus Omega 3 supplements, 4 capsules per day for up to 5 weeks. Each capsule contained 200 mg of docosahexaenoic acid (DHA) and 300 mg of eicosapentaenoic acid (EPA).
Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement
Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.

Placebo Comparator: 17P plus Placebo Supplement
Weekly 17 alpa hydroxyprogesterone caproate (17p) injections plus placebo capsules, 4 capsules per day for up to 5 weeks
Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplement
Participants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements




Primary Outcome Measures :
  1. Delivery before than 37 weeks gestation [ Time Frame: Up to 37 weeks gestation ]
    Delivery before 37 weeks including any miscarriages occurring after randomization


Secondary Outcome Measures :
  1. Delivery before 35 weeks gestation [ Time Frame: Up to 35 weeks gestation ]
  2. Delivery before 32 weeks gestation [ Time Frame: Up to 32 weeks gestation ]
  3. Delivery after 40 weeks gestation [ Time Frame: 40 weeks gestation or greater ]
  4. Pregnancy loss or neonatal death [ Time Frame: Randomization to hospital discharge (up to 25 weeks) ]
  5. Gestational age at delivery [ Time Frame: Delivery ]
  6. Birth weight less than 2,500 grams [ Time Frame: Birth ]
  7. Birth weight less than 1,500 grams [ Time Frame: Birth ]
  8. Birth size small for gestational age at less than 10th percentile [ Time Frame: Birth ]
  9. Birth size large for gestational age at more than 90th percentile [ Time Frame: Birth ]
  10. Admission to neonatal intensive care or intermediate care nursery [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  11. Neonatal retinopathy of prematurity [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  12. Intraventricular Hemorrhage at any grade [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  13. Intraventricular Hemorrhage Grade 3 or 4 [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  14. Neonatal patent ductus arteriosus [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  15. Neonatal necrotizing enterocolitis [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  16. Neonatal sepsis [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  17. Neonatal respiratory distress syndrome [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  18. Neonatal surfactant use [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  19. Neonatal bronchopulmonary dysplasia [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  20. Neonatal transient tacypnea [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  21. Neonatal supplemental oxygen support [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
  22. Neonatal ventilator support [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00135902


Locations
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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, 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)
Investigators
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Principal Investigator: Menachem Miodovnik, 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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00135902     History of Changes
Other Study ID Numbers: HD36801-Omega-3
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD027860 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD034136 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U10HD036801 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 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 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:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists