Preterm BirthPhase 3NCT00135902
Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
A Phase 3 study testing 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement in people with Preterm Birth, run by The George Washington University Biostatistics Center at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2005to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Documented history of previous singleton spontaneous birth
- Singleton pregnancy
- Gestational age at randomization between 16 and 22 weeks
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama - Birmingham
Birmingham, Alabama
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina
Northwestern University
Chicago, Illinois
Case Western University
Cleveland, Ohio
Ohio State University
Columbus, Ohio
Wayne State University
Detroit, Michigan
Columbia University
New York, New York
Drexel University
Philadelphia, Pennsylvania
University of Pittsburgh Magee Womens Hospital
Pittsburgh, Pennsylvania
Brown University
Providence, Rhode Island
University of Utah Medical Center
Salt Lake City, Utah
Wake Forest University School of Medicine
Winston-Salem, North Carolina
About this study
Official title: 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."
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement, 17 alpha-hydroxy progesterone caproate and Placebo supplement
- Keywords
- Preterm birth, Progesterone, Omega-3 fatty acid, Pregnancy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplementDrug
Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.
17 alpha-hydroxy progesterone caproate and Placebo supplementDrug
Participants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements
| Study group | Role | What they receive |
|---|---|---|
| 17P plus Omega-3 Supplement | Active comparator | 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). Receives: Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement |
| 17P plus Placebo Supplement | Placebo comparator | Weekly 17 alpa hydroxyprogesterone caproate (17p) injections plus placebo capsules, 4 capsules per day for up to 5 weeks Receives: Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery before than 37 weeks gestation
Delivery before 37 weeks including any miscarriages occurring after randomization
Measured: Up to 37 weeks gestation
Secondary outcomes (22)
Delivery before 35 weeks gestation
Measured: Up to 35 weeks gestation
Delivery before 32 weeks gestation
Measured: Up to 32 weeks gestation
Delivery after 40 weeks gestation
Measured: 40 weeks gestation or greater
Pregnancy loss or neonatal death
Measured: Randomization to hospital discharge (up to 25 weeks)
Gestational age at delivery
Measured: Delivery
Birth weight less than 2,500 grams
Measured: Birth
Birth weight less than 1,500 grams
Measured: Birth
Birth size small for gestational age at less than 10th percentile
Measured: Birth
Birth size large for gestational age at more than 90th percentile
Measured: Birth
Admission to neonatal intensive care or intermediate care nursery
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal retinopathy of prematurity
Measured: Delivery through neonatal discharge (up to 2 weeks)
Intraventricular Hemorrhage at any grade
Measured: Delivery through neonatal discharge (up to 2 weeks)
Intraventricular Hemorrhage Grade 3 or 4
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal patent ductus arteriosus
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal necrotizing enterocolitis
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal sepsis
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal respiratory distress syndrome
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal surfactant use
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal bronchopulmonary dysplasia
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal transient tacypnea
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal supplemental oxygen support
Measured: Delivery through neonatal discharge (up to 2 weeks)
Neonatal ventilator support
Measured: Delivery through neonatal discharge (up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startFeb 2005
- Primary completionMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Washington University Biostatistics Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Menachem Miodovnik, MD, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Elizabeth A Thom, PhD, Principal investigator, George Washington University Biostatistics CenterMargaret Harper, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135902
- Sponsor's protocol ID
- HD36801-Omega-3
- Other IDs
- U10HD021410, U10HD027869, U10HD027917, U10HD027860, U10HD027915, U10HD034208, U10HD034136, U10HD040500
- Status last verified
- Jul 2019
- First submitted
- 25 Aug 2005
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 12802023Olsen 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.
PubMed 14616269Duley L. Prophylactic fish oil in pregnancy. The Cochrane Pregnancy & Childbirth Database (Issue 2, 1995).
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. doi: 10.1111/j.1471-0528.2000.tb13235.x.
PubMed 10740336Olsen 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.
PubMed 11859044Reece 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.
PubMed 9125620Dunstan 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.
PubMed 14657879Cadroy 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.
PubMed 9637532Lee 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.
PubMed 12562875Calder 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.
PubMed 9481127Harper 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.
PubMed 20093894Harper 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.
PubMed 23635681Klebanoff 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.
PubMed 21508745Harper 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.
PubMed 21173653
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
- ClinicalTrials.gov ID
- NCT00135902
- Acronym / sponsor ID
- HD36801-Omega-3
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Progesterone, Omega-3 fatty acid, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- The George Washington University Biostatistics CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 17P plus Omega-3 Supplement | Active comparator | Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplementWeekly 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 comparator | Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplementWeekly 17 alpa hydroxyprogesterone caproate (17p) injections plus placebo capsules, 4 capsules per day for up to 5 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Documented history of previous singleton spontaneous birth
- Singleton pregnancy
- Gestational age at randomization between 16 and 22 weeks
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplementParticipants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements. | Drug | 17P plus Omega-3 Supplement |
| 17 alpha-hydroxy progesterone caproate and Placebo supplementParticipants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements | Drug | 17P plus Placebo Supplement |
Primary outcome
Delivery before than 37 weeks gestation
Time frame: Up to 37 weeks gestation
Delivery before 37 weeks including any miscarriages occurring after randomization
22 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Background: PubMed 12802023Meis 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.
- Background: PubMed 14616269Olsen 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.
- BackgroundDuley L. Prophylactic fish oil in pregnancy. The Cochrane Pregnancy & Childbirth Database (Issue 2, 1995).
- Background: PubMed 10740336Olsen 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.
- Background: PubMed 11859044Olsen 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.
- Background: PubMed 9125620Reece 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.
- Background: PubMed 14657879Dunstan 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.
- Background: PubMed 9637532Cadroy 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.
- Background: PubMed 12562875Lee 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.
- Background: PubMed 9481127Calder 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.
- Results publication: PubMed 20093894Harper 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.
- Derived from this study: PubMed 23635681Harper 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Miodovnik, MD principal investigator
Eunice Kennedy Shriver 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 Health Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement in people with Preterm Birth, run by The George Washington University Biostatistics Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery before than 37 weeks gestation (time frame: Up to 37 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00135902, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.