Mifepristone for Labor Induction

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

NCT05097326•Stanford University

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Pregnant patients between ages 18 to 45 years
•2. Singleton, live gestation
•3. Nulliparous
•4. Gestational age between 37 weeks 0 days - 42 weeks 0 days
•5. Fetus in cephalic presentation
•6. Patients admitted for labor induction
•7. Patients who are not in labor with intact membranes
•8. Patients with no contraindication for vaginal delivery (placenta previa, vasa previa, active genital herpes)
•9. Patients with no contraindications for mifepristone (chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, or other prostaglandins, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, or an intrauterine device (IUD) in place)
•10. Patients with a Bishop score \<6 at time of randomization
+1 more criteria

Exclusion Criteria

•1. Significant cardiac, renal, or hepatic maternal comorbidities, severe gestational hypertension or preeclampsia with severe features
•2. Pregnancies complicated by major fetal anomalies
•3. Patients with a uterine scar
•4. Pregnancies complicated by fetal growth restriction (Estimated fetal weight \<10%)
•5. Pregnancies complicated by oligohydramnios
•6. Fetuses with an estimated fetal weight \>4500 gm by recent ultrasound or Leopold's exam on admission
•7. Patients with class 3 obesity (BMI \>40)
•8. Fetuses with a persistent category 2 or 3 fetal heart tracing at labor induction admission
•9. Vaginal bleeding at the time of randomization
•10. Any indication for scheduled cesarean delivery
+3 more criteria

Locations (1)

Lucile Packard Children's Hospital

Palo Alto, California, United States

Key Dates

Start Date

June 27, 2022

Primary Completion Date

April 29, 2023

Completion Date

April 29, 2023

Last Updated

July 31, 2024

Enrollment

ACTUAL participants

Conditions

Induced Vaginal Delivery

Interventions

Mifepristone

DRUG

Misoprostol

DRUG

Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?

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Induced Vaginal Delivery

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COMPLETEDNA

Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term

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Induced Vaginal Delivery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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