Comparison of Efficacy of Transcervical Foley Catheter with or without Single Dose Oral Mifepris-tone on Vaginal Delivery Among Women Undergoing the Trial of Labour After Caesarean Section at Term –A Randomised, Double-blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Vaginal birth after caesarean rate (VBAC)
研究概览
简要总结
This is a prospective randomised controlled trial comparing the use of mifepristone plus Foley catheter vs Foley catheter alone for labour induction in women with a history of one prior LSCS. It evaluates efficacy, safety, maternal and neonatal outcomes.There is a paucity of data comparing the efficacy of Foley catheters with or without mifepristone as an induction agent in women planned for TOLAC. In women with previous LSCS, IOL is limited to mechanical methods using a foley catheter or hygroscopic agents like laminaria tents or dilapan. Mifepristone, as a single agent, has been used as an induction agent in women with previous LSCS A combination of these two methods would be more efficacious in reducing the use of uterotonic agents and induction delivery interval thereby increasing VBAC rate and decreasing the risk of scar dehiscence and rupture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age more than or equal to 18 years
- •Period of gestation: 370/7 – 42 weeks
- •Singleton live fetus in cephalic presentation with intact membranes
- •Reactive Non-Stress Test (NST)
- •Bishop score less than or equal to 4
- •Eligible for trial of labour after caesarean section (TOLAC).
排除标准
- •Requiring imminent delivery
- •With known contraindications/hypersensitivity to Mifepristone
- •Major fetal anomalies
- •Absolute contraindication for TOLAC.
结局指标
主要结局
Vaginal birth after caesarean rate (VBAC)
时间窗: At 24 hours | At 48 hours
次要结局
- Change in Bishop score(at 24 hours of intervention or)
- Need for induction/augmentation with oxytocin (dose/duration)(at 24 hours of intervention or)
- Duration of foley-in-situ(at 24 hours of intervention or)
- Induction to delivery interval (IDI)(Induction of labour with intervention to delivery of the baby)
- Maternal & Perinatal outcome(at 24 hours of intervention)
研究者
Dr Sumayya begum
Jawaharal Institute of Postgraduate Medical Education and Research (JIPMER)