This Phase III trial will be the first study to evaluate high-dose docosahexaenoic acid with reduction of earliest preterm birth as a primary outcome.
Columbus, OH — October 2017
A number of studies have suggested docosahexaenoic acid (DHA), an omega-3 fatty acid, may reduce the incidence of preterm birth among some pregnant women. A multicenter trial now underway is the first to specifically assess high-dose DHA for its effect on preterm birth incidence.
Called “ADORE” (for Assessment of DHA On Reducing Early preterm birth), the trial is taking place at the University of Kansas Medical Center, University of Cincinnati and The Ohio State University. Nationwide Children’s Hospital is a collaborating institution as well, and Lynette Rogers, PhD, principal investigator in the hospital’s Center for Perinatal Research, will be conducting assays on samples from enrolled pregnant woman.
“This is exactly the kind of translational research, the basic science and clinical collaboration, that Ohio State and Nationwide Children’s do so well,” says Catalin Buhimschi, MD, director of Maternal Fetal Medicine at The Ohio State Wexner Medical Center and a principal investigator in the Center for Perinatal Research at Nationwide Children’s. Dr. Buhimschi was senior author of the trial protocol, published this year in BMC Pregnancy and Childbirth.
“There is still so little known about how to prevent preterm birth, and anything that can have an effect is important,” he says. “This trial shows real promise.”
Approximately 1,000 pregnant woman 18 years of age or older who are 12-20 weeks of gestation are being recruited from the three large maternal medicine centers. They are randomized into two groups; the members of one group will be supplemented with 800 mg DHA, while members of the other group will receive a placebo. All of the women will receive a typical prenatal vitamin including 200 mg DHA.
The physician-researchers speculate that pregnancies at risk for early preterm birth include a disproportionate number with inflammation. Nationwide Children’s is the site analyzing the soluble form of receptor for advanced glycation end products (sRAGE) in maternal and cord blood, in an effort to determine the effects of DHA on inflammation.
While the trial is in some ways a “one size fits all” approach, investigators also hope to set the stage for more personalized approaches to reducing preterm births, says Dr. Buhimschi.
“One of the most interesting questions for us is, through the blood and biological samples we have available, and through sub-analyses of our group, can we learn which women will have the best results with DHA supplementation?” Dr. Buhimschi says.
Carlson SE, Gajewski BJ, Valentine CJ, Rogers LK, Weiner CP, DeFranco EA, Buhimschi CS. Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy and Childbirth. 2017 Feb 13; 17(1):62.