A comparative study of Mifepristone and Vaginal misoprostol Versus Vaginal misoprostol alone in the management of First trimester Missed miscarriage
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To investigate whether treatment with mifepristone plus vaginal misoprostol would result in a higher rate of successful medical management of missed miscarriage compared with vaginal misoprostol alone.
研究概览
简要总结
This study is a randomized, double blind, parallel group trial comparing the efficacy of mifepristone 200mg OD PO for 1 day and misoprostol 400mcg BD Per vaginal for 1 day in 31 patients Vs misoprostol 800mcg BD Per vaginal alone for 1 day in other 31 patients. The primary outcome will be to investigate whether treatment with mifepristone plus vaginal misoprostol would result in a higher rate of successful medical management of missed miscarriage compared with vaginal misoprostol alone. The secondary outcome will be to assess the efficacy and safety of combination of Mifepristone and misoprostol Vs efficacy and safety of misoprostol alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with scan finding of missed miscarriage the criteria include any one of these: Intrauterine gestation with gestational sac.
- •20 mm with no evidence of an embryo/yolk sac. Intrauterine gestation with CRL-6 mm without cardiac activity. Intrauterine gestation with gestational sac -20 mm/CRL -6 mm with no growth in 7 days. Radiological signs of abnormal pregnancy—irregular sac/debris within the gestational sac. Conscious and co-operative patients. Patients willing to give consent.
排除标准
- •Women who opted for alternative methods of miscarriage management (expectant or surgical).
- •Women with Missed miscarriages in second trimester.
- •Induced abortions.
- •Diagnosis of Incomplete miscarriage.
- •Hemodynamic instability.
- •Life threatening bleeding.
- •Contraindications to Mifepristone or Misoprostol.
- •Patients not willing to give consent.
结局指标
主要结局
To investigate whether treatment with mifepristone plus vaginal misoprostol would result in a higher rate of successful medical management of missed miscarriage compared with vaginal misoprostol alone.
时间窗: 1 assessment after 24 hours | 2 assessment after 48 hours
次要结局
- To assess the efficacy and safety of combination of Mifepristone and misoprostol Vs efficacy and safety of misoprostol alone.
研究者
Sai Raja Nandini Kilari
Dr MGR educational and research institute deemed to be university