Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,300
- 试验地点
- 10
- 主要终点
- Incidence of Cesarean Delivery
研究概览
简要总结
A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +/- other method). With this trial, the investigators aim to test our central hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal/neonatal morbidity compared with inpatient cervical ripening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to the group allocation
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligible for induction of labor
- •Live singleton gestation ≥37 weeks and <42 weeks
- •Nulliparous, ≥18 years of age with no previous deliveries >20 weeks
- •Cephalic presentation
- •Intact membranes
- •Bishop score ≤8 and cervical dilation <3 cm
- •English or Spanish speaking (Able to read/understand consent and instructions)
- •Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter
排除标准
- •Known oligohydramnios (DVP <2cm)
- •Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery)
- •Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile ≤6/10
- •Vaginal bleeding or concern for/known abruption prior to Foley placement
- •Chorioamnionitis
- •Any fetal growth restriction
- •Preeclampsia with severe features
- •Severe chronic hypertension
- •Type 1 diabetes or poorly controlled pre-gestational diabetes
- •Sickle cell disease
- •Major fetal anomaly
- •Women on therapeutic anticoagulation
- •Decreased fetal movement
- •HIV Positive (rationale: HIV positive patients require an IV medication at the start of labor induction which cannot be given as an outpatient. There is universal testing of HIV in the 3rd trimester to verify this exclusion criteria)
- •Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course
研究组 & 干预措施
Outpatient cervical ripening with Foley
Cervical ripening will begin with a Foley balloon in the outpatient setting
干预措施: Outpatient Foley catheter (Device)
Standard of care Inpatient cervical ripening
Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent
结局指标
主要结局
Incidence of Cesarean Delivery
时间窗: At delivery
Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine inpatient cervical ripening
次要结局
- Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)(From time of delivery to discharge from hospital, up to 6 weeks from delivery)
- Neonatal morbidity incidence(Within 6 weeks of delivery)
- Maternal morbidity incidence(Within 6 weeks of delivery)
- Maternal patient perception of control(From time of delivery to discharge from hospital, up to 6 weeks from delivery)
- Maternal overall length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Maternal postpartum length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Neonatal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- NICU admission(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- NICU stay greater than 48 hours(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Perceived stress scale-10 questions(From time of delivery to discharge from hospital, up to 6 weeks from delivery)
研究者
Lisa Levine
Associate Professor, Division of Maternal Fetal Medicine
University of Pennsylvania