Comparison of effectiveness of letrozole with misoprostol versus mifepristone with misoprostol in achieving complete abortions in first trimester among women aged 18 – 40 years – A Randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To determine the addition of letrozole versus mifepristone with misoprostol in achieving complete abortion in first trimester among woman between age of 18-40 years.
研究概览
简要总结
This study aims to investigate the effectiveness of the combination of regimen of Tablet Letrozole 20 mg per oral stat with Tablet Misoprostol 800 mcg per oral versus Tablet Mifepristone 200 mg per oral with Tablet Misoprostol 800 mcg per oral in achieving complete abortions in first trimester medical abortion among woman of age 18-40 years of age
A randomized controlled trial will be employed and ANC mothers seeking first trimester medical abortions among the age group 18 to 40 years satisfying inclusion criteria will be provided with Tablet Letrozole 20 mg po stat with Tablet Misoprostol 800 mcg po or Tablet Mifepristone 200 mg with Tablet Misoprostol 800 mcg based on convenient sampling
The effectiveness of the regimen will be based on the complete abortion rate in each of the regimen
The overarching goal of the research is to determine which regimen has better complete abortion rates, lesser adverse effects and better patient satisfaction in terms of lesser blood loss, decreased hospital stay and lesser abdominal pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Women with single live intrauterine pregnancy less than 12 weeks intended for medical abortion
- •No comorbidities
- •Not allergic to drug in usage
- •Willing for follow up.
排除标准
- •Antenatal women belong to First trimester (1-12 weeks of gestation) and more than 32 weeks of gestation 2) Women with medical complications/ Hematological disorders 3) Women with Hemoglobinopathies 4) Liver disorder like jaundice, cirrhosis, or renal failure 5) Antenatal women with Hemoglobin level less than 7g%.
结局指标
主要结局
To determine the addition of letrozole versus mifepristone with misoprostol in achieving complete abortion in first trimester among woman between age of 18-40 years.
时间窗: 72 hours
次要结局
- 1. To evaluate number of abortions requiring instrumentation follow up.(2.To evaluate additional dose of Misoprostol required for complete abortion in both regimens.)
- • To evaluate the induction to complete abortion time interval in both regimen(• To evaluate the number of abortions requiring follow up instrumentation.)
研究者
Deeksha B
Aarupadai Veedu medical college and hospital