Induction of labour-An enigma,Concurrent versus sequential use of oral misoprostol plus foleys catheter for induction of labour.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- comparison of induction to delivery time interval between two groups
研究概览
简要总结
Induction of labour is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, different induction methods are used. Recently with steadily increasing rates of induction , implementing effective and safe procedures at proper gestation of pregnancy can significantly decrease maternal and foetal complications. Different mechanical and medical methods are used to induce labour, but all of the existing methods are associated with medical risks. Therefore, while choosing labour induction method, numerous aspects like cost effectiveness, safety, and rate of operative delivery should be considered. An informed consent will be taken. Consenting eligible women are enrolled in the study and randomized to either concurrent or sequential use of oral misoprostol and foley’s catheter. Clinical and demographic data is recorded. Favourability of cervix assessed with modified bishop’s score. For the concurrent group, foley’s catheter and oral misoprostol administration done on the same day . For the sequential group, foley’s catheter is introduced in the first day and oral misoprostol administration done on the next day. We compare primary outcome which is Induction to delivery interval and secondary outcomes such as vaginal delivery within 24 hours, number of doses needed to induce labour, need of oxytocin for augmentation of labour, caesarean section rate, maternal complications, neonatal complications and abnormalities in uterine contractility
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
- 21.00 Year(s) 至 38.00 Year(s)(—)
- 性别
- Female
入选标准
- •primigravida, full term singleton pregnancy, cephalic presentation ,intact membranes, reactive NST, modified bishop’s score less than 6,no other complications.
排除标准
- •previous uterine scar, rupture of membranes, placenta previa , intrauterine foetal death, latex allergy, presence of contraindications to vaginal delivery.
结局指标
主要结局
comparison of induction to delivery time interval between two groups
时间窗: baseline and 1 week, 6 weeks
次要结局
- Maternal complications-Post partum pyrexia, Postpartum hemorrhage.
- Neonatal complications-APGAR score, Admission in NICU, Meconium stained amniotic fluid.
- Abnormalities in uterine contractility like uterine hypertonus, uterine tachysystole, uterine hyperstimulation
- Vaginal delivery within 24 hours
- Number of doses needed to induce labour
- Need of oxytocin for augmentation of labour
- Cesarean section rate
研究者
Dr Preetha George
Malankara Orthodox Syrian Church Medical College
