Mifepristone for Labor Induction

NCT05097326 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 62448
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced Vaginal Delivery

Outcome Measures

Primary Outcomes (12)

• Number of Uterine Contractions

  Measured total number of uterine contractions per hour - with and without fetal heart rate decelerations.

  Up to approximately 72 hours, from start of labor induction to removal of transcervical balloon

• Number of Participants With Uterine Tachysystole

  Participants with uterine tachysystole (more than 5 contractions in 10 minutes with and without fetal heart rate decelerations) .

  Up to approximately 72 hours from start of labor induction

• Number of Minutes in Hypertonus

  Time in hypertonus (a single contraction lasting more than 2 minutes) per hour.

  Up to approximately 72 hours, from start of labor induction until the time of delivery

• Time to Complete Cervical Dilation

  Total time from start of labor induction to complete cervical dilation (10 cm).

  Up to approximately 72 hours from start of labor induction

• Time to Delivery

  Up to approximately 72 hours, from start of labor induction until the time of delivery

• Total Labor and Delivery Unit Admission Duration Time

  Total time on Labor \& Delivery from the time of admission to the time of transfer to postpartum unit

  Up to approximately 80 hours after the time of Labor and delivery admission

• 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

  Active labor defined as cervical of dilation \>=6 cm.

  Up to approximately 72 hours from start of labor induction

• Number of Patients With Severe Maternal Morbidity

  Number of participants with serious maternal morbidity based on CDC criteria for major maternal morbidity and mortality

  Up to approximately 1 week after hospital admission for delivery

• Mean Neonatal Arterial Cord Blood pH

  Laboratory values for neonatal arterial cord blood pH. Arterial pH lower than 7.0 indicates metabolic acidosis.

  Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample)

• Number of Participants With Neonatal APGAR Score <7

  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).

  At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment)

• Number of Patients With Serious Neonatal Morbidity

  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

  Up to 7 days after birth

Study Arms (2)

Mifepristone

ACTIVE COMPARATOR

Participants will be given mifepristone with insertion of the cervical Cook balloon for labor induction

Drug: Mifepristone

Misoprostol

ACTIVE COMPARATOR

Participants will be given misoprostol with insertion of the cervical Cook balloon for labor induction

Drug: Misoprostol

Interventions

Mifepristone DRUG

Mifepristone 200mg taken orally

Mifepristone

Misoprostol DRUG

Misoprostol 50 mcg taken orally, and may receive additional doses of misoprostol 50 - 100 mcg as needed

Misoprostol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Principal Investigator
• Organization: Stanford University

gynresearch@stanford.edu

(650) 497-5175

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: June 27, 2022
• Primary Completion: April 29, 2023
• Study Completion: April 29, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)