Mifepristone for Labor Induction

Phase 3

Completed

Conditions: Induced Vaginal Delivery

Interventions: Drug: Mifepristone
Drug: Misoprostol

Registration Number: NCT05097326

Lead Sponsor: Stanford University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Pregnant patients between ages 18 to 45 years
Singleton, live gestation
Nulliparous
Gestational age between 37 weeks 0 days - 42 weeks 0 days
Fetus in cephalic presentation
Patients admitted for labor induction
Patients who are not in labor with intact membranes
Patients with no contraindication for vaginal delivery (placenta previa, vasa previa, active genital herpes)
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)
Patients with a Bishop score <6 at time of randomization
Transcervical balloon in place <3 hours prior to the time of randomization without prior cervical preparation

Exclusion Criteria

Significant cardiac, renal, or hepatic maternal comorbidities, severe gestational hypertension or preeclampsia with severe features
Pregnancies complicated by major fetal anomalies
Patients with a uterine scar
Pregnancies complicated by fetal growth restriction (Estimated fetal weight <10%)
Pregnancies complicated by oligohydramnios
Fetuses with an estimated fetal weight >4500 gm by recent ultrasound or Leopold's exam on admission
Patients with class 3 obesity (BMI >40)
Fetuses with a persistent category 2 or 3 fetal heart tracing at labor induction admission
Vaginal bleeding at the time of randomization
Any indication for scheduled cesarean delivery
Hypersensitivity to oxytocin
Uterine contractions equal to or greater than 5 in 10 minutes for sustained 30 minutes
Hypersensitivity to prostaglandins

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifepristone	Mifepristone	Participants will be given mifepristone with insertion of the cervical Cook balloon for labor induction
Misoprostol	Misoprostol	Participants will be given misoprostol with insertion of the cervical Cook balloon for labor induction

Primary Outcome Measures

Name	Time	Method
Number of Uterine Contractions	Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon	Measured total number of uterine contractions per hour - with and without fetal heart rate decelerations.
Number of Participants With Uterine Tachysystole	Up to approximately 72 hours from start of labor induction	Participants with uterine tachysystole (more than 5 contractions in 10 minutes with and without fetal heart rate decelerations) .
Time to Delivery	Up to approximately 72 hours, from start of labor induction until the time of delivery
Number of Patients Who Undergo Cesarean Delivery	Up to approximately 72 hours from start of labor induction
Number of Patients Able to Achieve Active Labor	Up to approximately 72 hours from start of labor induction	Active labor defined as cervical of dilation \>=6 cm.
Number of Patients With Serious Neonatal Morbidity	Up to 7 days after birth	Defined as need for respiratory support within 72 hours after birth, hypoxic-ischemic encephalopathy, seizure, infection, meconium aspiration syndrome, intracranial or subgaleal hemorrhage, hypotension requiring vasopressor support, admission to neonatal intensive care unit
Number of Minutes in Hypertonus	Up to approximately 72 hours, from start of labor induction until the time of delivery	Time in hypertonus (a single contraction lasting more than 2 minutes) per hour.
Number of Participants With Neonatal APGAR Score <7	At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment)	Compare the APGAR scores (at 1 and 5 minutes). The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2; scores are summed for an overall score of 0 to 10 (higher scores reflect better neonatal outcomes).
Number of Patients With Severe Maternal Morbidity	Up to approximately 1 week after hospital admission for delivery	Number of participants with serious maternal morbidity based on CDC criteria for major maternal morbidity and mortality
Mean Neonatal Arterial Cord Blood pH	Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample)	Laboratory values for neonatal arterial cord blood pH. Arterial pH lower than 7.0 indicates metabolic acidosis.
Time to Complete Cervical Dilation	Up to approximately 72 hours from start of labor induction	Total time from start of labor induction to complete cervical dilation (10 cm).
Total Labor and Delivery Unit Admission Duration Time	Up to approximately 80 hours after the time of Labor and delivery admission	Total time on Labor \& Delivery from the time of admission to the time of transfer to postpartum unit