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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 : October 3, 2016
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

August 25, 2005
August 26, 2005
October 3, 2016
February 2005
March 2007   (Final data collection date for primary outcome measure)
Delivery less than 37 completed weeks gestation including any miscarriages occurring after randomization
  • Primary Outcome:
  • Delivery less than 37 completed weeks gestation including any miscarriages occurring after randomization
Complete list of historical versions of study NCT00135902 on ClinicalTrials.gov Archive Site
  • 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
  • Secondary Outcomes:
  • 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
Not Provided
Not Provided
 
Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
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."

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Preterm Birth
Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 fish oils
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
Same as current
March 2008
March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00135902
HD36801-Omega-3
HD21410
HD27869
HD27917
HD27860
HD27915
HD34116
HD34208
HD34136
HD40500
HD40485
HD40544
HD40545
HD40560
HD40512
Yes
Not Provided
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.
The George Washington University Biostatistics Center
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
The George Washington University Biostatistics Center
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP