NCT04342741已完成不适用
A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial
National University of Malaysia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Neonatal sepsis
研究概览
简要总结
A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.
详细描述
The study evaluated the efficacy and safety of outpatient versus inpatient Foley catheter cervical ripening and patients' satisfaction. Sixty low-risk women were randomized to outpatient and inpatient management of intracervical Foley catheter digital insertion. The outpatient group was provided with verbal and written 24-hours contact information and instructions. Both groups were reassessed the next morning unless labor had begun or the catheter had dropped off.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •singleton
- •gestational age beyond 37 weeks
- •cephalic presentation
- •intact membranes
- •Bishop score less than 6
- •lives within 10km from National University Malaysia Medical Centre or able to reach within 30 minutes
- •readily available transport
排除标准
- •intrauterine death
- •intrauterine fetal growth restriction
- •estimated fetal weight more than 4000gram
- •fetal anomalies
- •abnormal pre-induction cardiotocograph
- •non-vertex presentation
- •unstable lie
- •hypertension
- •allergy to latex
- •previous uterine scar
- •history of antepartum haemorrhage
- •parity of 6 and more
- •placenta praevia
- •suspected cephalopelvic disproportion
结局指标
主要结局
Neonatal sepsis
时间窗: From birth up to 30 days
Percentage of neonates with sepsis
Caesarean section rate
时间窗: From the time of recruitment until delivery
Percentage of Caesarean section
次要结局
- Maternal age(At the time of recruitment)
- Birth weight(At the time of delivery)
- Arterial cord blood acidity or alkalinity(At the time of delivery)
- Pre-pregnancy maternal body mass index(At the time of recruitment)
- Indication(At the time of recruitment)
- Duration of oxytocin use(At time of recruitment until delivery)
- Intrapartum pyrexia(At the time of delivery)
- Feeling alone during induction(At the time of recruitment until delivery)
- Embarrassed by the method(At the time of recruitment until active phase of labour)
- Gestation at recruitment(At the time of recruitment)
- Bishop score pre-induction(Pre-intervention)
- Augmentation with oxytocin(At time of recruitment until delivery)
- Duration from induction until delivery(At time of recruitment until delivery)
- Primary postpartum haemorrhage(Immediately at delivery up to 42 days)
- Occupation(At the time of recruitment)
- Parity(At the time of recruitment)
- Duration from amniotomy until delivery(At time of recruitment until delivery)
- Delivery within 24 hours(At time of recruitment until delivery)
- Neonatal C-reactive protein(At the time of delivery)
- Ability to cope with discomfort(At the time of recruitment until active phase of labour)
- Duration of sleep(At the time of recruitment until delivery)
- Feeling of unsafe during cervical ripening(At the time of recruitment until active phase of labour)
- Ethnicity(At the time of recruitment)
- Education level(At the time of recruitment)
- Bishop score at second assessment(From insertion of Foley catheter until labour established or the following morning)
- Discomfort with foley catheter(At the time of recruitment until active phase of labour)
- Intention to use the method again(Through study completion until delivery)
- Management at second assessment(At time of recruitment until delivery)
- Duration from induction until favourable Bishop score(At time of recruitment until delivery)
- Duration of inpatient stay(At time of recruitment until delivery)
- Total blood loss(At the time of delivery)
- Neonatal white cell count(At the time of delivery)
- Able to rest and relax(At the time of recruitment until delivery)
研究者
Rahana Abd Rahman
Co-primary investigator
National University of Malaysia
研究点 (2)
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