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Birth Defects |
Abnormalities |
Clinical Trial: Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
This study is currently recruiting patients.
Verified by National Institute of Child Health and Human Development (NICHD) August 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Preterm Birth Pregnancy | Drug: 17 P Hydroxyprogesterone Caproate and Omega-3 fish oils | Phase III |
MedlinePlus related topics: High Risk Pregnancy
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
Secondary Outcomes: 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
Expected Total Enrollment: 800
Study start: February 2005; Expected completion: March 2008
Data entry closure: December 2007
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
Accepts Healthy Volunteers
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
Location and Contact Information
Alabama
University of Alabama - Birmingham, Birmingham, Alabama, United States; Recruiting
Dwight Rouse, MD, Principal Investigator
Illinois
Northwestern University, Chicago, Illinois, United States; Recruiting
Alan M Peaceman, MD, Principal Investigator
Michigan
Wayne State University, Detroit, Michigan, United States; Recruiting
Yoram Sorokin, MD, Principal Investigator
New York
Columbia University, New York, New York, United States; Recruiting
Ronald Wapner, MD, Principal Investigator
North Carolina
Wake Forest University School of Medicine, Winston Salem, North Carolina, United States; Recruiting
Margaret Harper, MD MS, Principal Investigator
University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States; Recruiting
John M Thorp, Jr., MD, Principal Investigator
Ohio
Ohio State University, Columbus, Ohio, United States; Recruiting
Jay Iams, MD, Principal Investigator
Case Western University, Cleveland, Ohio, United States; Recruiting
Brian Mercer, MD, Principal Investigator
Pennsylvania
University of Pittsburgh Magee Womens Hospital, Pittsburgh, Pennsylvania, United States; Recruiting
Steve N Caritis, MD, Principal Investigator
Drexel University, Philadelphia, Pennsylvania, United States; Recruiting
Anthony Sciscione, DO, Principal Investigator
Rhode Island
Brown University, Providence, Rhode Island, United States; Recruiting
Marshall Carpenter, MD, Principal Investigator
Texas
University of Texas - Southwest, Dallas, Texas, United States; Recruiting
Kenneth J Leveno, MD, Principal Investigator
Utah
University of Utah Medical Center, Salt Lake City, Utah, United States; Recruiting
Michael W Varner, MD, Principal Investigator
Catherine Y Spong, MD, Principal Investigator, National Institute of Child Health and Human Development (NICHD)
Elizabeth A Thom, PhD, Principal Investigator, George Washington University Biostatistics Center
Margaret Harper, MD, Principal Investigator, Wake Forest University
More Information
http://www.bsc.gwu.edu/mfmu
Publications
Olsen SF, Secher NJ, Bjornsson S, Weber T, Atke A. The potential benefits of using fish oil in relation to preterm labor: the case for a randomized controlled trial? Acta Obstet Gynecol Scand. 2003 Nov;82(11):978-82. Review. No abstract available.
Olsen SF, Secher NJ, Tabor A, Weber T, Walker JJ, Gluud C. Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team. BJOG. 2000 Mar;107(3):382-95.
Olsen SF, Secher NJ. Low consumption of seafood in early pregnancy as a risk factor for preterm delivery: prospective cohort study. BMJ. 2002 Feb 23;324(7335):447.
Reece MS, McGregor JA, Allen KG, Harris MA. Maternal and perinatal long-chain fatty acids: possible roles in preterm birth. Am J Obstet Gynecol. 1997 Apr;176(4):907-14.
Dunstan JA, Mori TA, Barden A, Beilin LJ, Taylor AL, Holt PG, Prescott SL. Fish oil supplementation in pregnancy modifies neonatal allergen-specific immune responses and clinical outcomes in infants at high risk of atopy: a randomized, controlled trial. J Allergy Clin Immunol. 2003 Dec;112(6):1178-84.
Cadroy Y, Dupouy D, Boneu B. Arachidonic acid enhances the tissue factor expression of mononuclear cells by the cyclo-oxygenase-1 pathway: beneficial effect of n-3 fatty acids. J Immunol. 1998 Jun 15;160(12):6145-50.
Lee JY, Plakidas A, Lee WH, Heikkinen A, Chanmugam P, Bray G, Hwang DH. Differential modulation of Toll-like receptors by fatty acids: preferential inhibition by n-3 polyunsaturated fatty acids. J Lipid Res. 2003 Mar;44(3):479-86. Epub 2002 Dec 1.
Calder PC. Dietary fatty acids and the immune system. Nutr Rev. 1998 Jan;56(1 Pt 2):S70-83. Review. No abstract available.
Last Updated: August 25, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00135902
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
Resources
- (National Women's Health Information Center, OWH, HHS)
- A Guide to understanding Hunter Syndrome: MPS II (National MPS Society)
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