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

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00135902
First received: August 25, 2005
Last updated: July 19, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Preterm Birth
Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 fish oils
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Secondary Outcome Measures:
  • 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

Enrollment: 800
Study Start Date: February 2005
Study Completion Date: March 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135902

Locations
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
Investigators
Principal Investigator: Catherine Y Spong, 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 School of Medicine
  More Information

Additional Information:
Publications:
Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S, National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. New England Journal of Medicine 348(24):2379-85,
Duley L. Prophylactic fish oil in pregnancy. The Cochrane Pregnancy & Childbirth Database (Issue 2, 1995).

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Catherine Y Spong, MD, Chief, Pregnancy and Perinatology Branch, NICHD, NIH
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
Study First Received: August 25, 2005
Last Updated: July 19, 2010
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Preterm birth
Progesterone
Omega-3 fatty acid
Pregnancy

Additional relevant MeSH terms:
Pregnancy Complications
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on April 22, 2014