Mifepristone for Labor Induction
Trial ID or NCT#
Status
NOT RECRUITING
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
Eligibility 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
- 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
Investigator(s)
View on ClinicalTrials.gov
