Mifepristone for Labor Induction (MiLI)

Stanford University

Status and phase: Completed; Phase 3

Conditions: Induced Vaginal Delivery

Treatments: Drug: Mifepristone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05097326

62448

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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
11. Transcervical balloon in place <3 hours prior to the time of randomization without prior cervical preparation

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
11. Hypersensitivity to oxytocin
12. Uterine contractions equal to or greater than 5 in 10 minutes for sustained 30 minutes
13. Hypersensitivity to prostaglandins

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Mifepristone

Active Comparator group

Description:

Participants will be given mifepristone with insertion of the cervical Cook balloon for labor induction

Treatment:

Drug: Mifepristone

Misoprostol

Active Comparator group

Description:

Participants will be given misoprostol with insertion of the cervical Cook balloon for labor induction

Treatment:

Drug: Misoprostol