Mifepristone for Labor Induction

NCT ID: NCT05097326

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2023-04-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mifepristone

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

Group Type: ACTIVE_COMPARATOR

Mifepristone

Intervention Type: DRUG

Mifepristone 200mg taken orally

Misoprostol

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

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

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

Interventions

Mifepristone

Mifepristone 200mg taken orally

Intervention Type: DRUG

Misoprostol

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lucile Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

62448

Identifier Type: -

Identifier Source: org_study_id