SAFETY AND EFFICACY OF ORAL MIFEPRISTONE VERSUS INTRACERVICAL DINOPROSTONE GEL AS A CERVICAL RIPENING AGENT AMONG PREGNANT WOMEN REQUIRING LABOUR INDUCTION – A RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in bishop score
研究概览
简要总结
Induction of labour is stimulation of uterine contractions before the spontaneous onset of labour with or without ruptured membranes. Labour induction is usually carried out for maternal and fetal conditions.
PGE2, PGE1 and Oxytocin are the most common pharmacological agents used for labour induction.
Prostaglandin E2(PGE2) is effective in achieving cervical ripening and also in activating myometrial contractility.
Mifepristone is a potent antiprogesterone and antiglucocorticoid Compound.It also increases uterine activity and causes cervical effacement and dilation and termination of pregnancy.
Mifepristone has an established role in termination of pregnancy during the early first and the second trimesters.
Recent researches done in India have shown mifepristone is effective as a cervical ripening agent in labour induction with higher rate of vaginal delivery with insignificant maternal and perinatal complications.4,5
Dinoprostone (PGE2) gel is also a effective cervical agent but it needs strict aseptic precautions,skill for intracervical insertion and requires refrigerator for storage whereas Oral Mifepristone is easy to administer,stable at room temperature and patient can remain ambulatory which is more convenient for the patients
Present study is being performed to determine the safety and efficacy of oral mifepristone and compare it with intracervical Dinoprostone gel as a cervical ripening agent in low risk singleton pregnant women who have completed 40weeks of pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Willing to participate
- •Primigravida
- •Singleton pregnancy,Cephalic presentation.
- •Gestational age 40+ weeks.
- •Maternal age>19years
- •No contraindications for prostaglandins or mifepristone.
- •No contraindication for vaginal delivery
- •Modified Bishop’s Score < 6
- •Intact membranes.
- •10.Women with history of 1 or 2 previous abortions.
排除标准
- •Breech presentation Cephalopelvic disproportion History of 3 or more abortions Estimated fetal weight > 4.5 kg or < 2kg Multigravida,Twin pregnancy Obstetric complications like Diabetes ,Abruptio placenta or Placenta previa.
- •Abnormal fetal heart rate patterns.
- •Premature rupture of membranes.
- •Active genital infection.
- •Contraindication for mifepristone Chorioamnionitis Myoma or uterine anomalies IUD’S IVF Conception.
结局指标
主要结局
Change in bishop score
时间窗: at 8, 16 and 24 hours after administration of the drug
次要结局
- Induction to delivery interval,mode of delivery,,cesarean for failed induction ,any adverse events,maternal and fetal outcome(24 -48 hours)