Mifepristone as an Adjunct to Transcervical Balloon for Labor Induction (MiLI): A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Uterine Contractions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mifepristone
Participants will be given mifepristone with insertion of the cervical Cook balloon for labor induction
干预措施: Mifepristone (Drug)
Misoprostol
Participants will be given misoprostol with insertion of the cervical Cook balloon for labor induction
干预措施: Misoprostol (Drug)
结局指标
主要结局
Number of Uterine Contractions
时间窗: 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.
Number of Participants With Uterine Tachysystole
时间窗: 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) .
Time to Delivery
时间窗: Up to approximately 72 hours, from start of labor induction until the time of delivery
Number of Patients Who Undergo Cesarean Delivery
时间窗: Up to approximately 72 hours from start of labor induction
Number of Patients Able to Achieve Active Labor
时间窗: Up to approximately 72 hours from start of labor induction
Active labor defined as cervical of dilation \>=6 cm.
Number of Patients With Serious Neonatal Morbidity
时间窗: 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
Number of Minutes in Hypertonus
时间窗: 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.
Number of Participants With Neonatal APGAR Score <7
时间窗: 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).
Number of Patients With Severe Maternal Morbidity
时间窗: 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
Mean Neonatal Arterial Cord Blood pH
时间窗: 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.
Time to Complete Cervical Dilation
时间窗: Up to approximately 72 hours from start of labor induction
Total time from start of labor induction to complete cervical dilation (10 cm).
Total Labor and Delivery Unit Admission Duration Time
时间窗: 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
次要结局
未报告次要终点