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Mifepristone for Labor Induction
Not Recruiting
Trial ID: NCT05097326
Purpose
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.
Official Title
Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial
Stanford Investigator(s)
Kate Shaw, MD MS
Associate Professor of Obstetrics and Gynecology
Eligibility
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
Intervention(s):
drug: Mifepristone
drug: Misoprostol
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305