Phase 3 N=30 Randomized Treatment

Mifepristone for Labor Induction

Induced Vaginal Delivery

Bottom Line

View on ClinicalTrials.gov: NCT05097326 ↗

Enrolled (actual)

Serious AEs

13.3%

Results posted

Jul 2024

Primary outcome: Primary: Number of Uterine Contractions — 103; 112; 9; 15 contractions — p=0.44

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mifepristone (Drug); Misoprostol (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Stanford University
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Uterine Contractions	103; 112; 9; 15	0.44
PRIMARY Number of Participants With Uterine Tachysystole	0; 5; 1; 5	0.04 sig
PRIMARY Number of Minutes in Hypertonus	1.33; 0.93	0.63
PRIMARY Time to Complete Cervical Dilation	24.0; 16.0	0.01 sig
PRIMARY Time to Delivery	26.0; 19.0	0.04 sig
PRIMARY Total Labor and Delivery Unit Admission Duration Time	29.0; 21.0	0.04 sig
PRIMARY Number of Patients Who Undergo Cesarean Delivery	5; 2	0.68
PRIMARY Number of Patients Able to Achieve Active Labor	13; 13	1
PRIMARY Number of Patients With Severe Maternal Morbidity	0; 1	1
PRIMARY Mean Neonatal Arterial Cord Blood pH	7.16; 7.17	0.90
PRIMARY Number of Participants With Neonatal APGAR Score <7	5; 1; 1; 0	0.17
PRIMARY Number of Patients With Serious Neonatal Morbidity	3; 0	0.22

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 Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05097326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.