The Biostatistics Center to Coordinate National Study on Cesareans and Opioid Use

The Maternal Fetal Medicine Units Network (MFMU Network), which includes The Biostatistics Center based at the George Washington University Milken Institute School of Public Health, has received funding from the National Institutes of Health (NIH) to study opioid prescription patterns and pain management after a cesarean delivery.

The award is part of the NIH’s Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. NIH launched the NIH HEAL Initiative in April 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. The NIH HEAL Initiative aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose and achieve long-term recovery from opioid addiction. The MFMU Network’s award is one of 375 grant awards across 41 states made by the NIH in fiscal year 2019 to apply scientific solutions to reverse the national opioid crisis.

The MFMU Network, comprised of 12 clinical centers nationwide, a data coordinating center and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), was established in 1986 to conduct studies to improve maternal and fetal outcomes. The Biostatistics Center serves as the data coordinating center for the network. In this role, the Biostatistics Center manages numerous aspects of the study, including working with the researchers on the study design, developing the operation manuals; designing and implementing the data collection systems; and analyzing data for the study.

The research funded by the NIH award will focus on opioid prescriptions given to women when they leave the hospital after a cesarean delivery. A cesarean is the most commonly performed surgical procedure in the United States, with 1 in 3 women giving birth via cesarean. Most doctors prescribe opioids for pain management after a cesarean. Recent studies show up to 75 percent of women who filled their opioid prescription after a cesarean have unused medication. The remaining tablets go unguarded and undisposed—providing an important source of opioids contributing to the current crisis.

The study aims to improve opioid prescribing practices at discharge so that less medication remains unused without compromising post-discharge pain management by implementing Individualized Opioid Prescription Protocols, which are tailored to a specific woman’s pain need and includes the patient in the decision-making process on the number of opioids prescribed. The MFMU Network will conduct a randomized trial of 5,500 women undergoing a cesarean who will either receive an individualized opioid prescription or a fixed amount. The researchers will examine participant’s pain levels, recovery and overall health at one week, two weeks, six weeks, and 90 days postpartum.

“This trial, in which the intervention empowers the patient, will answer the question whether a smaller number of opioids prescribed can control pain,” said Rebecca Clifton, PhD, the principal investigator of the MFMU Network Data Coordinating Center and an associate research professor of epidemiology at Milken Institute SPH. “The ultimate goal is to reduce the number of excess opioids in circulation and the number of women that require a refill, which is linked to persistent opioid use later in life. The Biostatistics Center will play a critical role in the design, conduct and analysis of this important study.”

For more information on the MFMU Network, click here.