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
15 other identifiers
interventional
800
1 country
12
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."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2005
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJuly 12, 2019
July 1, 2019
2.1 years
August 25, 2005
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delivery before than 37 weeks gestation
Delivery before 37 weeks including any miscarriages occurring after randomization
Up to 37 weeks gestation
Secondary Outcomes (22)
Delivery before 35 weeks gestation
Up to 35 weeks gestation
Delivery before 32 weeks gestation
Up to 32 weeks gestation
Delivery after 40 weeks gestation
40 weeks gestation or greater
Pregnancy loss or neonatal death
Randomization to hospital discharge (up to 25 weeks)
Gestational age at delivery
Delivery
- +17 more secondary outcomes
Study Arms (2)
17P plus Omega-3 Supplement
ACTIVE COMPARATORWeekly 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).
17P plus Placebo Supplement
PLACEBO COMPARATORWeekly 17 alpa hydroxyprogesterone caproate (17p) injections plus placebo capsules, 4 capsules per day for up to 5 weeks
Interventions
Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.
Participants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements
Eligibility Criteria
You may qualify if:
- Documented history of previous singleton spontaneous birth
- Singleton pregnancy
- Gestational age at randomization between 16 and 22 weeks
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Alabama - Birmingham
Birmingham, Alabama, United States
Northwestern University
Chicago, Illinois, United States
Wayne State University
Detroit, Michigan, United States
Columbia University
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Case Western University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Drexel University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Related Publications (14)
Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, 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. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140.
PMID: 12802023BACKGROUNDOlsen 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. doi: 10.1034/j.1600-0412.2003.00334.x. No abstract available.
PMID: 14616269BACKGROUNDDuley L. Prophylactic fish oil in pregnancy. The Cochrane Pregnancy & Childbirth Database (Issue 2, 1995).
BACKGROUNDOlsen 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. doi: 10.1111/j.1471-0528.2000.tb13235.x.
PMID: 10740336BACKGROUNDOlsen 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. doi: 10.1136/bmj.324.7335.447.
PMID: 11859044BACKGROUNDReece 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. doi: 10.1016/s0002-9378(97)70620-3.
PMID: 9125620BACKGROUNDDunstan 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. doi: 10.1016/j.jaci.2003.09.009.
PMID: 14657879BACKGROUNDCadroy 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.
PMID: 9637532BACKGROUNDLee 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. doi: 10.1194/jlr.M200361-JLR200. Epub 2002 Dec 1.
PMID: 12562875BACKGROUNDCalder PC. Dietary fatty acids and the immune system. Nutr Rev. 1998 Jan;56(1 Pt 2):S70-83. doi: 10.1111/j.1753-4887.1998.tb01648.x. No abstract available.
PMID: 9481127BACKGROUNDHarper M, Thom E, Klebanoff MA, Thorp J Jr, Sorokin Y, Varner MW, Wapner RJ, Caritis SN, Iams JD, Carpenter MW, Peaceman AM, Mercer BM, Sciscione A, Rouse DJ, Ramin SM, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Omega-3 fatty acid supplementation to prevent recurrent preterm birth: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):234-242. doi: 10.1097/AOG.0b013e3181cbd60e.
PMID: 20093894RESULTHarper M, Li L, Zhao Y, Klebanoff MA, Thorp JM Jr, Sorokin Y, Varner MW, Wapner RJ, Caritis SN, Iams JD, Carpenter MW, Peaceman AM, Mercer BM, Sciscione A, Rouse DJ, Ramin SM, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Change in mononuclear leukocyte responsiveness in midpregnancy and subsequent preterm birth. Obstet Gynecol. 2013 Apr;121(4):805-811. doi: 10.1097/AOG.0b013e3182878a80.
PMID: 23635681DERIVEDKlebanoff MA, Harper M, Lai Y, Thorp J Jr, Sorokin Y, Varner MW, Wapner RJ, Caritis SN, Iams JD, Carpenter MW, Peaceman AM, Mercer BM, Sciscione A, Rouse DJ, Ramin SM, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Fish consumption, erythrocyte fatty acids, and preterm birth. Obstet Gynecol. 2011 May;117(5):1071-1077. doi: 10.1097/AOG.0b013e31821645dc.
PMID: 21508745DERIVEDHarper M, Zheng SL, Thom E, Klebanoff MA, Thorp J Jr, Sorokin Y, Varner MW, Iams JD, Dinsmoor M, Mercer BM, Rouse DJ, Ramin SM, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Cytokine gene polymorphisms and length of gestation. Obstet Gynecol. 2011 Jan;117(1):125-130. doi: 10.1097/AOG.0b013e318202b2ef.
PMID: 21173653DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
February 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2008
Last Updated
July 12, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
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.