Mifepristone for Labor Induction

Induced Vaginal Delivery Clinical Trial

— MiLI  

Official title:

Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097326
• Other study ID #: 62448
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2022
• Est. completion date: April 29, 2023

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 29, 2023
• Est. primary completion date: April 29, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induced Vaginal Delivery

Intervention

Drug:
• Mifepristone
Mifepristone 200mg taken orally
• Misoprostol
Misoprostol 50 mcg taken orally, and may receive additional doses of misoprostol 50 - 100 mcg as needed

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of uterine contractions from time of medication administration to removal of the transcervical balloon	Measured total number of uterine contractions per hour - with and without fetal heart rate decelerations from time of medication administration to removal of transcervical balloon	Up to approximately 72 hours after administration of the study medication
Primary	Measured number of total minutes of uterine tachysystole or hypertonus per hour from the time of medication administration until the time of delivery	Measured number of total minutes of uterine tachysystole (more than 5 contractions in 10 minutes with and without fetal heart rate decelerations) or hypertonus (a single contraction lasting more than 2 minutes) per hour from the time of medication administration until the time of delivery	Up to approximately 72 hours after administration of study medication
Primary	Time from study medication administration to complete cervical dilation	Total time from medication administration to complete cervical dilation (10 cms)	Up to approximately 72 hours after the study medication administration
Primary	Time from study medication administration to delivery		Up to approximately 72 hours after the study medication has been administered
Primary	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
Primary	Number of patients who undergo cesarean delivery		Up to approximately 72 hours after the start of labor induction
Primary	Number of patients able to achieve active labor (6 cm)		Up to approximately 72 hours after the start of labor induction
Primary	Number of patients with severe maternal morbidity	Number of participants with serious maternal morbidity or death based on CDC criteria for major maternal morbidity and mortality	Up to approximately 1 week after hospital admission for delivery
Primary	Mean neonatal arterial cord blood pH	Laboratory values for neonatal arterial cord blood pH	Within approximately 2 hours after delivery (approximately 5 minutes to obtain sample)
Primary	Mean neonatal APGAR scores from 0-10	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. The score is reported at 1 minute and 5 minutes after birth for all infants,	At 1 minute and 5 minutes of infant life (approximately 10 seconds to perform each assessment)
Primary	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