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
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Condition or disease | Intervention/treatment | Phase |
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Preterm Birth | Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplement | Phase 3 |
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.
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 |

Arm | Intervention/treatment |
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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).
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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
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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 |
- Delivery before than 37 weeks gestation [ Time Frame: Up to 37 weeks gestation ]Delivery before 37 weeks including any miscarriages occurring after randomization
- Delivery before 35 weeks gestation [ Time Frame: Up to 35 weeks gestation ]
- Delivery before 32 weeks gestation [ Time Frame: Up to 32 weeks gestation ]
- Delivery after 40 weeks gestation [ Time Frame: 40 weeks gestation or greater ]
- Pregnancy loss or neonatal death [ Time Frame: Randomization to hospital discharge (up to 25 weeks) ]
- Gestational age at delivery [ Time Frame: Delivery ]
- Birth weight less than 2,500 grams [ Time Frame: Birth ]
- Birth weight less than 1,500 grams [ Time Frame: Birth ]
- Birth size small for gestational age at less than 10th percentile [ Time Frame: Birth ]
- Birth size large for gestational age at more than 90th percentile [ Time Frame: Birth ]
- Admission to neonatal intensive care or intermediate care nursery [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal retinopathy of prematurity [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Intraventricular Hemorrhage at any grade [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Intraventricular Hemorrhage Grade 3 or 4 [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal patent ductus arteriosus [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal necrotizing enterocolitis [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal sepsis [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal respiratory distress syndrome [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal surfactant use [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal bronchopulmonary dysplasia [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal transient tacypnea [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- Neonatal supplemental oxygen support [ Time Frame: Delivery through neonatal discharge (up to 2 weeks) ]
- 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 |
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

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
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 |
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 |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Preterm birth Progesterone Omega-3 fatty acid Pregnancy |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Progesterone 17 alpha-Hydroxyprogesterone Caproate 11-hydroxyprogesterone |
Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Estrogen Antagonists Hormone Antagonists |