Misoprostol Dosing in BMI Greater Than 30: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)
研究概览
简要总结
The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.
详细描述
As of 2019, almost 1 in 4 women in the United States had their labor induced with almost 9 in 10 women requiring different methods to prepare their cervix for induction. There have been several research studies in the past designed to look at the fastest and safest method for labor induction, however very few studies have been done in women with a Body Mass Index (BMI) greater than or equal to 30 kg/m2.
Women with a BMI greater than or equal to 30 kg/m2, also classified as Obesity, are known to have longer labor induction times and experience more "failed" labor inductions requiring cesarean delivery (C-Sections). Obese women are also at a higher risk of developing complications during labor and postpartum such as excessive vaginal bleeding and infections.
Due to limited information, the American College of Obstetricians and Gynecologists (ACOG) currently recommends a standard dosing of 25 or 50 micrograms of vaginal misoprostol for labor induction in all women. However, there are studies which specifically compared the 25 microgram and 50 microgram misoprostol doses and found that women have significantly shorter time to deliveries without any harmful effects to mother or baby.
The investigators will conduct a randomized controlled trial to determine if 50 micrograms of vaginal misoprostol, when compared to the standard 25 micrograms, reduces the time from the start of labor induction to delivery in obese women. Women who are admitted to Labor & Delivery for the purposes of labor induction will be randomized to undergo either 25 micrograms or 50 micrograms of vaginal misoprostol for cervical ripening. Women and their infants will be followed until the time of their discharge.
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
- Double (Participant, Care Provider)
盲法说明
This study will be double blinded with the research participants and providers/nursing masked to the interventions.
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
- •Singleton gestation
- •Age 18 years or older
- •Gestational age >= 36 weeks
- •BMI >= 30 kg/m2 at time of labor induction
- •Cephalic presentation (including successful external cephalic version)
- •Cervical dilation <= 3cm
- •Intent to proceed with cervical ripening
排除标准
- •Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.)
- •Contraindication to prostaglandin administration (significant allergy, prior cesarean delivery, etc.)
- •Multiple gestations
- •Gestational age < 36 weeks
- •Non-reassuring fetal heart tracing
- •Evidence of clinical chorioamnionitis
- •Significant vaginal bleeding with concern for abruption
- •Prior cesarean delivery or uterine surgery
- •Major fetal anomaly or demise
- •Cervix >3cm
- •No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.)
- •Uterine tachysystole (defined as >= 5 contractions within a 10m period)
- •Fetal Growth Restriction (EFW <= 5% or elevated/absent/reversed Umbilical Artery dopplers)
- •Inability to give consent (inability to read/write in English or Spanish)
研究组 & 干预措施
50 Micrograms Vaginal Misoprostol (Intervention)
Subjects in this arm will be randomized to the 50 micrograms of vaginal misoprostol (intervention) group, they will be admitted to labor and delivery and undergo placement of 50 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.
干预措施: 50 Micrograms Vaginal Misoprostol (Intervention) (Drug)
25 Micrograms Vaginal Misoprostol (Control)
Subjects in this arm will be randomized to the 25 micrograms of vaginal misoprostol (control) group, they will be admitted to labor and delivery and undergo placement of 25 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.
干预措施: 25 Micrograms Vaginal Misoprostol (Control) (Drug)
结局指标
主要结局
Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)
时间窗: From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days
次要结局
- Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations(Assessed 4 hours post-misoprostol placement)
- Number of Participants Receiving Terbutaline(From baseline to the time of delivery)
- Number of Participants Diagnosed With Clinical Chorioamnionitis(From baseline to the time of delivery)
- Number of Participants Diagnosed With Postpartum Hemorrhage(Assessed at time of delivery)
- Interval Time From Labor Induction to Vaginal Delivery(From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days)
- Patient Satisfaction Six Simple Questions, Question 1(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction Six Simple Questions, Question 2(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction Six Simple Questions, Question 3(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction Six Simple Questions, Question 4(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction Six Simple Questions, Question 5(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction Six Simple Questions, Question 6(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction (Labor Pain Scale, Question 1)(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction (Labor Pain Scale, Question 2)(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Number of Cesarean Deliveries(Assessed following delivery, through study completion which is estimated at 1 year.)
- Number of Participants Exhibiting Uterine Tachysystole(Assessed 4 hours post-misoprostol placement)
- Patient Satisfaction (Labor Pain Scale, Question 3)(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
- Patient Satisfaction (Labor Pain Scale, Question 4)(Assessed postpartum day one following delivery, up to 5 days post-delivery.)
研究者
Lorie Harper
Maternal Fetal Medicine Division Director
University of Texas at Austin