NCT03725397已完成不适用
Inpatient Versus Outpatient Foley Cervical Ripening Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Time of Foley catheter extrusion
研究概览
简要总结
To compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting
详细描述
The aim of the current study is to compare the efficacy and safety of cervical ripening with transcervical Foley catheter in inpatient vs outpatient setting in a diverse, urban population within the United States. We hypothesize that there will be no differences in time-to-delivery, failed induction rates, cesarean section rates, or maternal/neonatal morbidity and that there will be no differences in total length of stay (LOS), hours of sleep, active labor duration, and perceived satisfaction between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
randomized double blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication for Induction of Labor is present
- •Gestational age > 37 completed weeks with absence of comorbidities with an optimal dating (ultrasonography was performed before 22 weeks gestation)
- •Singleton fetus in cephalic presentation confirmed with an ultrasound at the time of presentation for induction of labor
- •Cervical exam with Bishop Score <6
- •Intact membranes
- •Normal vital signs (blood pressure < 140/90, normal body temperature) at the time of presentation for Induction of Labor and within the last 24 hours
- •Maternal age ≥18 years of age
排除标准
- •Any contraindication for vaginal birth by institutional policy
- •Multiple gestation
- •History of cesarean delivery
- •Oligohydramnios/polyhydramnios/anhydramnios (MVP <2cm)
- •Rupture of membranes
- •Poorly controlled diabetes (Hgb A1C>8% and/or fingerstick glucose above target >50% of the time in the past week)
- •Poorly controlled chronic hypertension, gestational hypertension or preeclampsia (patient requiring IV antihypertensives within 4 hours of arrival)
- •Vaginal bleeding
- •Any conditions that require continuous electronic fetal monitoring either by institutional policy or provider determination (intrahepatic cholestasis of pregnancy, intrauterine growth restriction, abnormal non-stress test, others)
- •Fetal anomaly with anticipated neonatal intensive care unit admission
- •Fetal demise
- •HIV infection, presence of genital herpetic lesion
- •History of substance abuse during this pregnancy
- •History of precipitous delivery (delivery <3hrs from onset of labor)
- •Poor access to care (social, distance to hospital > 45 min, limited transportation)
- •Poor social situation, history of domestic violence, untreated/uncontrolled psychiatric condition
- •Inability to give informed consent, history of mental retardation
- •Strong preference for inpatient management
- •Inability to understand English or Spanish
结局指标
主要结局
Time of Foley catheter extrusion
时间窗: within 24 hours
Antepartum time of Foley catheter extrusion before patient being brought to labor
次要结局
- Total time in hospital(no max but an average of 3 days)
- Use of oxytocin(3 days)
- Neonatal Intensive Care Unit (NICU)(within 7 days of Foley placement)
- Total time slept during pre-induction(during labor)
- Analgesia used during pre-induction(within 24 hours before Pitocin initiation)
- Bishop score(during labor)
- Fever over 38 degrees C(within 7 days of Foley placement)
- Total time in cervical ripening(from labor induction to delivery time)
- APGAR scores(5 minutes of life)
- Hospital charges(within 30 days after discharge)
研究者
研究点 (4)
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