Mifepristone for Labor Induction

Stanford University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Induced Vaginal Delivery

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Uterine Contractions

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

Time frame: 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) .

Time frame: 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.

Time frame: 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).

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

Time to Delivery

Time frame: 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

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

Number of Patients Who Undergo Cesarean Delivery

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 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

Time frame: Up to 7 days after birth

Mifepristone for Labor Induction

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes