Clinical Trial Investigates the Link Between Outpatient Treatment and Lower C-Section Rates, Better Outcomes
AUSTIN, Texas – Almost a quarter of America’s pregnant women undergo labor induction, a procedure that has more than doubled in rate between 1990 and 2006, according to the American College of Obstetricians and Gynecologists. Now, the first large-scale, multicenter clinical trial is underway intended to understand the safety and effectiveness of using an outpatient version of the Foley catheter during labor induction — the process of stimulating the uterus to contract before labor begins on its own. This at-home method of inducing labor allows moms to begin labor at home instead of going to the hospital first.
Evidence-based strategies to improve labor management and reduce the rate of cesarean deliveries is of significant importance. “The high rate of cesarean-section deliveries in the U.S. is considered a public health crisis among ob-gyns,” said co-principal investigator Alison Cahill, M.D., a professor in the Department of Women’s Health at Dell Medical School at The University of Texas at Austin.
“We already know that more than one-third of pregnant people in the U.S. deliver by C-section — which is related to greater incidence of complications like hemorrhage, infection and blood clots. This trial could support at-home labor induction as a promising and under-used method to lower C-section delivery rates, thereby making labor safer,” said Cahill, who also serves as associate dean of translational research at Dell Med.
During labor, the uterus experiences contractions and the cervix starts to open. Cervical ripening with outpatient Foley involves inserting a small balloon into the cervical canal and then slowly inflating it to help open the cervix.
A recent meta-analysis of eight small, randomized trials showed a 37% lower risk of C-section delivery with outpatient Foley, possibly due to better sleep and relaxation at home, fewer medical interventions and fewer failed inductions — evidence that spurred Cahill and co-investigators to explore the value of at-home induction as a safer, more cost-effective alternative.
A Health Equity Argument for At-Home Induction
In addition to being possibly a safer approach, outpatient induction may also be a more equitable and convenient childbirth alternative.
“Staying in the hospital for two extra days with inpatient labor induction places a strain on some women and their families in terms of access and expense,” said Cahill. “This is an opportunity for women to participate in getting better care for themselves. A patient’s autonomy over their labor experience is incredibly important to the labor and birth experience. So, we are exploring a potentially more equitable approach to childbirth.”
The four-year-long clinical trial in first-time moms, known as the “Cervical Ripening as an Outpatient Method Using the Foley” (COMFORT) Trial, was begun in May and includes investigation sites at the University of Pennsylvania Perelman School of Medicine and the University of Utah School of Medicine. The study tracks how effective at-home labor induction is at doing the following:
- Lowering risks of having a C-section delivery.
- Decreasing chances of childbirth complications, including hemorrhage, needing a transfusion, infection, blood clot, or being readmitted to the hospital.
- Reducing negative effects on the health of the mother and baby.
The researchers will also attempt to better understand the various barriers and enablers to the process of integrating new evidence into the practice of inducing labor with an outpatient Foley.
The study design reflects a large sample of diverse patient populations from across the U.S. — a key feature that promotes applicability of the study findings to a wide variety of demographics. Participants have been recruited from across different regions of the country and among various socioeconomic groups, including underserved patient populations, large private practices, federally qualified health care centers, and more.
This study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development.