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临床试验/CTRI/2026/04/108686
CTRI/2026/04/108686尚未招募不适用

Comparison of letrozole vs mifepristone pretreatment with misoprostol in second trimester abortion induction : A RCT

Dr. Rajender Prasad government medical college , kangra1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

In second trimester, women seek termination of pregnancy due to various social and medical factors including delayed decisions, lack of awareness, poverty, limited education and availability of abortion services. Common reasons for mid-trimester abortions include fetal anomalies, uterine defects, placental causes and medical disorders.

Abortions account for 8 percent of maternal mortality ratio in India and nearly 10 women reportedly die due to unsafe abortions everyday in India. Several methods are used for mid-trimester abortions, with medical methods being the most popular due to their effectiveness and fewer complications. Letrozole, mifepristone and misoprostol are commonly used drugs for this purpose. Mechanical methods using hygroscopic dilators and foleys catheter are also employed. Surgical methods like dilatation and evacuation are also used but have higher risks associated.

In many countries, mifepristone is not available and is expensive compared to letrozole. There is a need to find a cheaper and easily available alternative. Letrozole is easily available as it is registered for treatment of estrogen dependent advanced breast cancers and infertility.

Further studies are needed to refine abortion techniques, aiming to decrease procedure duration and potential complications while ensuring higher efficacy and patient tolerance.

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • maternal age 18-40 years
  • singleton pregnancy
  • gestational age between 13 to 24 weeks based on last menstrual period ,clinical examination, ultrasonography.

排除标准

  • grand multipara
  • multiple pregnancy
  • anemia (hb less then 8gm per dl)
  • any history of allergy to letrozole, mifepristone or misoprostol
  • presence of fibroid uterus
  • presence of intrauterine device
  • history of coagulopathy or thromboembolism
  • any medical disorder like liver disease, asthma, porphyria , hypertension, heart disease.

研究者

发起方
Dr. Rajender Prasad government medical college , kangra
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Yamini Gupta

Dr. Rajender Prasad Govt. Medical College, Kangra

研究点 (1)

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