Skip to main content
OpenTrials
Completed

NCT Number: NCT05097326

Mifepristone for Labor Induction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Induced Vaginal Delivery

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <6 at time of randomization
  • Transcervical balloon in place <3 hours prior to the time of randomization without prior cervical preparation

Exclusion criteria

  • 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

Treatment and study plan

Mifepristone

Drug

Mifepristone 200mg taken orally

Misoprostol

Drug

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

Primary outcomes

  1. Number of Uterine Contractions

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

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

  2. Number of Participants With Uterine Tachysystole

    Time frame: Up to approximately 72 hours from start of labor induction

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

  3. Number of Minutes in Hypertonus

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

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

  4. Time to Complete Cervical Dilation

    Time frame: Up to approximately 72 hours from start of labor induction

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

  5. Time to Delivery

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

  6. Total Labor and Delivery Unit Admission Duration Time

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

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

  7. Number of Patients Who Undergo Cesarean Delivery

    Time frame: Up to approximately 72 hours from start of labor induction

  8. Number of Patients Able to Achieve Active Labor

    Time frame: Up to approximately 72 hours from start of labor induction

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

  9. Number of Patients With Severe Maternal Morbidity

    Time frame: Up to approximately 1 week after hospital admission for delivery

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

  10. Mean Neonatal Arterial Cord Blood pH

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

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

  11. Number of Participants With Neonatal APGAR Score <7

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

    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).

  12. Number of Patients With Serious Neonatal Morbidity

    Time frame: Up to 7 days after birth

    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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: MiLI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.