Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Achievement of complete cervical dilation
研究概览
简要总结
The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI >40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.
详细描述
The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI >40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity.
The investigators plan to conduct a randomized controlled double blinded trial. Patients who are scheduled for induction of labor after 34 weeks gestation, have a BMI >40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
- •Speaks English or Spanish
- •Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
- •Age 18 years old or older
- •Viable, single, cephalic fetus
- •Intent to proceed with cervical ripening - cervical exam: dilation < 5 cm
- •Contractions < 5 per 10 minutes
排除标准
- •History of cesarean delivery
- •Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
- •Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
- •Contraindications to labor (cardiac, neurosurgical, need for cesarean)
- •Age < 18yo
- •Fetal growth restriction with abnormal umbilical artery Doppler indices
- •Cervical dilation >5 cm
- •Contractions >5 per 10 minutes
- •Significant vaginal bleeding with concern for placental abruption
- •Non-reassuring fetal status or fetal heart rate decelerations
- •Fetal demise or major fetal anomaly
- •Inability to give consent
研究组 & 干预措施
Intervention - 50 mcg vaginal misoprostol
Participants will receive 50 mcg vaginal misoprostol every 4 hours.
干预措施: Misoprostol (Drug)
Control - 25 mcg vaginal misoprostol
Participants will receive 25 mcg vaginal misoprostol every 4 hours.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Achievement of complete cervical dilation
时间窗: Start of IOL until complete dilation
次要结局
- Composite maternal morbidity (need for transfusion, sepsis, ICU admission, death)(Start of IOL until postpartum day 4)
- Time interval from start of IOL to 6 cm cervical dilation/active labor(Start of IOL until 6 cm dilation)
- Time interval from start of IOL to vaginal delivery(Start of IOL until delivery)
- Time interval from start of IOL to delivery(Start of IOL until delivery)
- Incidence of vaginal deliveries(Start of IOL until delivery)
- Number of patients with tachysystole(Start of IOL until delivery)
- Number of patients requiring terbutaline(Start of IOL until delivery)
- Indication for cesarean delivery(Start of IOL until delivery)
- Number of patients with tachysystole with non reassuring fetal heart rate (NRFHT)(Start of IOL until delivery)
- Composite neonatal morbidity (NICU admission, Apgar score =<7 at 5 minutes, sepsis, cord gas arterial pH <7.10 and/or base deficit < -12, active cooling protocol, death)(Start of IOL until discharge or day of life 30)
- Achievement of 6 cm cervical dilation/active labor(Start of IOL until 6 cm dilation)
- Incidence of cesarean deliveries(Start of IOL until delivery)
- Cervical exam at time of cesarean delivery(Start of IOL until delivery)
- Number of patients with chorioamnionitis(Start of IOL until delivery)
- Number of patients with postpartum hemorrhage(Start of IOL until discharge, assessed up to 4 days)
- Time interval from start of induction of labor (IOL) to complete cervical dilation(Start of IOL until complete dilation)