CTRI/2024/12/078374尚未招募2 期
Simultaneous or sequential use of Foley’s catheter and oxytocin for induction of labour -Randomised controlled trial
Dr Swati sharma1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- to determine induction to delivery interval and compare it in both groups
研究概览
简要总结
we aim to determine whether simultaneous use of Foley’s and oxytocin will be advantageous to achieve vaginal delivery after IOL without an increase in the oxytocin to delivery interval or the CS rate as compared to sequential use. If found beneficial, it will reduce overnight hospital stay for cervical ripening with Foley’s kept for 12 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Gestational age greater than 34 weeks 2.Bishops score six or less 3.Single live fetus with cephalic presentation 4.Intact membranes 5.Reactive non stress test (NST).
排除标准
- •1.Previous uterine scar (caesarean section or myomectomy) 2.Parity greater than 3 3.Fetal congenital malformations 4.Severe fetal growth restriction(estimated fetal weight less than 3rd centile and/or abnormal Doppler changes in umbilical artery ) 5.Pre-eclampsia with severe features /eclampsia 6.Antepartum haemorrhage 7.Premature rupture of membranes (PROM) 8.Cervicovaginal infections 9.Medical disorders (heart disease, seizure disorder, severe anaemia, renal disease, uncontrolled diabetes, uncontrolled hypertension, retropositive status).
结局指标
主要结局
to determine induction to delivery interval and compare it in both groups
时间窗: 11 months
次要结局
- 1. Caesarean section (CS) rate 2. Incidence of uterine contraction abnormalities 3. Infectious morbidity in the mother (chorioamnionitis or puerperal sepsis) 4. Composite Neonatal outcome(11 months)
研究者
Dr Swati sharma
PGIMER Chandigarh
研究点 (1)
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