Cervical Ripening as an Outpatient Method Using the Foley (COMFORT) (NCT05759988)
Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
🩺 Plain-English Summary (8th-Grade Level)
A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +/- other method). With this trial, the investigators aim to test our central hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal/neonatal morbidity compared with inpatient cervical ripening.
Who can join: Review the eligibility criteria below.
Location: Christiana Care Health Services, Inc. — Newark, Delaware
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Christiana Care Health Services, Inc. — Newark, Delaware
- Princeton Medical Center — Plainsboro, New Jersey
- University of Pennsylvania — Philadelphia, Pennsylvania
- University of Texas at Austin — Austin, Texas
- Intermountain Health Utah Valley Hospital — Provo, Utah
- University of Utah — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (215) 283-7373
Email: lisa.levine@pennmedicine.upenn.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Induction of Labor Affected Fetus / Newborn clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.