Efficacy of Letrozole pretreatment prior to Misoprostol in first trimester Medical Termination of Pregnancy- A prospective clinical study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Letrozole is a non steroidal, third generation aromatase inhibitor ,it acts by suppressing oestrogen synthesis , thereby causing endometrial thinning and increased uterine sensitivity to prostoglandins. Thus pretreatment with Letrozole before Misoprostol may create hormonal milieu more favourable for uterine evacuation. Mifepristone is commonly used with Misoprostol , but it has limitations such as high cost and limited availability in many regions. WHO recommends usage of Letrozole along with Misoprostol in 1st trimester Medical Termination of Pregnancy.Given limited data in Indian population, this study aims to evaluate the efficacy and safety of Letrozole pretreatment before Misoprostol in 1st trimester MTP.
Study group - will be given T.LETROZOLE + T.MISOPROSTOL. Control group-will be given T.MIFEPRISTONE+ T.MISOPROSTOL.
Study population- All patients eligible for MTP as per MTP Act (upto 9wks/63 days)
This study hypothese that,
1.Induction abortion interval is less and rate of complete abortion without need of surgical intervention is more in study group when compared with control group.
2.Total duration of vaginal bleeding is less in study group than control group.
This study aims to provide cheap and safe alternative regimen in 1st trimester MTP.
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 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women age 18 yrs and above.
- •Confirmed intrauterine pregnancy upto 9 wks /63 days (based on Ultasound findings).
- •Indications for Termination as per MTP Act .
- •Hemoglobin levels greater than 10g/dl.
- •Willing to participate and provide written and informed consent.
排除标准
- •Hypersensitivity to Misoprostol/ Letrozole.
- •Multiple pregnancy.
- •Uterine anomalies.
- •Bronchial asthma.
- •Steroid hormone dependant cancer.
- •Systemic diseases.
- •Coagulopathies/Thromboembolism.
- •Suspected ectopic or Molar pregnancy.
- •Severe or recurrent Liver disease or Pruritis of Pregnancy.
- •Breast feeding.
- •Acute illness of any nature.
研究者
SOUNDHARYA V
GOVERNMENT RAJAJI HOSPITAL , MADURAI