NCT05097326

Mifepristone for Labor Induction

Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to explore mifepristone as an option for induction of labor at term by evaluating the efficacy of mifepristone use for cervical preparation. Since the Labor Induction versus Expectant Management in Low-Risk Nulliparous Women (ARRIVE) trial supporting that elective induction after 39 weeks decreases cesarean sections and morbidity, rates of elective term inductions are increasing. At Lucile Packard Children's Hospital at Stanford University specifically, approximately 40% of spontaneous vaginal deliveries follow induction of labor, with an average induction time of 20 hours. Previous studies have established the maternal and neonatal safety of mifepristone in term inductions, however, this study will assess the difference in overall time from induction to complete cervical dilation, delivery, and the total time on Labor and Delivery.

Conditions

• Induced Vaginal Delivery

Interventions

Type	Name	Description
DRUG	Mifepristone	Mifepristone 200mg taken orally
DRUG	Misoprostol	Misoprostol 50 mcg taken orally, and may receive additional doses of misoprostol 50 - 100 mcg as needed

Timeline

• Start date: 2022-06-27
• Primary completion: 2023-04-29
• Completion: 2023-04-29
• First posted: 2021-10-28
• Last updated: 2024-07-31
• Results posted: 2024-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study