Clinical trial NCT05097326: Mifepristone for Labor Induction
Official title: Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Induced Vaginal Delivery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Uterine Contractions
timeFrame: Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon
measure: Number of Participants With Uterine Tachysystole
timeFrame: Up to approximately 72 hours from start of labor induction
measure: Number of Minutes in Hypertonus
timeFrame: Up to approximately 72 hours, from start of labor induction until the time of delivery
measure: Time to Complete Cervical Dilation
timeFrame: Up to approximately 72 hours from start of labor induction
measure: Time to Delivery
timeFrame: Up to approximately 72 hours, from start of labor induction until the time of delivery
measure: Total Labor and Delivery Unit Admission Duration Time
timeFrame: Up to approximately 80 hours after the time of Labor and delivery admission
measure: Number of Patients Who Undergo Cesarean Delivery
timeFrame: Up to approximately 72 hours from start of labor induction
measure: Number of Patients Able to Achieve Active Labor
timeFrame: Up to approximately 72 hours from start of labor induction
measure: Number of Patients With Severe Maternal Morbidity
timeFrame: Up to approximately 1 week after hospital admission for delivery
measure: Mean Neonatal Arterial Cord Blood pH
timeFrame: Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample)
measure: Number of Participants With Neonatal APGAR Score <7
timeFrame: At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment)
measure: Number of Patients With Serious Neonatal Morbidity
timeFrame: Up to 7 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
References: