Comparison of PGE2 gel and trans cervical Foley’s single balloon catheter for induction of labor in term pregnancy: An Open labelled Randomized control trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- improvement of Bishops score more than equal to 6
研究概览
简要总结
Foley’s transcervical balloon catheter is yet to be explored for its full potential as a sole
agent for induction of labour at term (≥37 weeks of gestation), specially in a non-scarred
uterus. If foley’s efficacy comes out as non-inferior in comparison to pharmacological agent
like PGE2 gel for induction of labour, it can be very useful in a low resource setting.
PGE2 gels have been reported to cause various side effects, most common of them being,
uterine hyperstimulation (2.5%), abdominal discomfort (2.0%), Gastrointestinal side effects
like diarrhea, nausea and vomiting (1%), headache (0.5%) and fetal heart rate changes
(5.7%) .On the contrary, no incidence of aberrant fetal heart rate patterns occurred during
preinduction cervical ripening using foley’s single balloon transcervical catheter. In addition
to this, Foley’s is relatively an inexpensive means for induction.
Foley’s balloon catheter has been proven to be a successful agent of induction in a scarred
uterus by various studies,
However, very few studies have evaluated the role of Foley’s catheter as an inducing agent
in non-scarred uterus. We aim to compare the efficacy of foley’s catheter with intracervical
Prostaglandin gel as an inducing agent in women at term pregnancy with non-scarred uterus.
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
- •Antenatal female with ≥ 37 weeks of gestation
- •Singleton pregnancy
- •Cephalic presentation
- •Bishop’s score ≤ 3
- •Intact membranes
- •Cases where conditions were fulfilled for vaginal delivery.
排除标准
- •Multiple pregnancy
- •Bishop’s score less than equal to
- •Malpresentation
- •Absent membranes
- •Antepartum haemorrhage
- •Previous uterine scar
- •Acute vaginal infection at time
- •Any Contraindication to vaginal delivery 9.
结局指标
主要结局
improvement of Bishops score more than equal to 6
时间窗: after 18 hours of intervention
次要结局
- time interval from induction to active labour(10 hours)
- time interval from induction to delivery(24 hours)
研究者
SUPRIYA
AIIMS PATNA