Kaiser Permanente Southern California researchers will join a national consortium to study the neonatal safety of opioids when taken by pregnant women.
The Medication Exposure in Pregnancy Risk Evaluation Program consortium, which includes 8 health care organizations across the United States, is funded by the U.S. Food and Drug Administration.
The FDA hopes to learn more about neural tube defects, a severe congenital anomaly of the central nervous system that can develop in the fetuses of women who are exposed to opioids during the first trimester of pregnancy. The study is important because previous studies have produced conflicting results.
The primary aim is to evaluate whether the risk of neural tube defects is different among infants exposed to maternal prescription opioids during the first trimester of pregnancy compared to infants of women not exposed to opioids during that time. Several comparison groups are proposed to control for confounding. In addition, women who are currently pregnant and receive opioid prescriptions will be interviewed.
Pregnant women are generally excluded from clinical trials that evaluate drugs because of unknown risks for fetuses and mothers. Therefore, assessing the safety of taking drugs in pregnancy can only be determined using large multisite, observational studies such as this one.
Denise Boudreau, PhD, of Group Health Research Institute is the principal investigator. KPSC study collaborators are Craig Cheetham, PharmD, MS, and Rulin Hechter, MD, PhD. Other KP investigators are Marsha Raebel PharmD, from Kaiser Permanente Colorado; De-Kun Li , PhD, MPH, from Kaiser Permanente Northern California; and David Smith, RPh, MHA, PhD, from Kaiser Permanente Northwest.
External study collaborators are Susan Andrade, ScD, from the Meyers Primary Care Institute; Sengwee Darren Toh, ScD, from Harvard Pilgrim Health Care Institute; Marie Griffin, MD, PhD, from the Vanderbilt University School of Medicine; Pam Pawloski, PharmD, from HealthPartners Institute; and Nandini Selvam, PhD, MPH, from Health Core, Inc.