CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Mifepristone +1 moredrug
Likely dose
Mifepristone 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05097326
NCT05097326Phase 3Completed

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

Stanford University·interventional·Posted Oct 28, 2021·Updated Jul 31, 2024

In Brief

A Phase 3 clinical trial evaluating Mifepristone and Misoprostol for Induced Vaginal Delivery. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 28, 2021
Enrollment StartJun 27, 2022
Primary CompletionApr 29, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.7 years ago

Interventions

Mifepristonedrug

Mifepristone 200mg taken orally

Misoprostoldrug

Misoprostol 50 mcg taken orally, and may receive additional doses of misoprostol 50 - 100 mcg as needed