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临床试验/CTRI/2025/08/092551
CTRI/2025/08/092551尚未招募2/3 期

Induction of labour-An enigma,Concurrent versus sequential use of oral misoprostol plus foleys catheter for induction of labour.

Malankara Orthodox Syrian Church Medical College1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2025年8月25日最近更新:

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

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Preetha George

Malankara Orthodox Syrian Church Medical College

研究点 (1)

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