Methotrexate Vs Letrozole in the medical management of unruptured ectopic pregnancy-a comparative study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the resolution of ectopic pregnancy by estimating serum human chorionic gonadotropin (beta hCG) levels below 5mIU/mL
研究概览
简要总结
This study aims to show the great promise letrozole holds for the treatment of ectopic pregnancy. Methotrexate has been a medical alternative to surgery for some time. But as an antimetabolite and immune suppressant chemotherapeutic drug methotrexate comes with toxic effects that may threaten a patients health and future fertility. Hence this trial is done to give an alternative drug that can be used in place of methotrexate as a standard treatment for medical management of unruptured ectopic pregnancy
My randomized prospective cohort study will include women with undisturbed ectopic pregnancy who have no contraindications to methotrexate or letrozole treatment. The study will have two groups comprising women who will receive medical treatment with methotrexate group 1 and the other group recieving letrozole group 2. A comparision will be drawn between the two drugs on the basis of the results obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Ectopic pregnancy confirmed by physician.
- •Serum beta HCG less than 3000 mIU/mL.
- •Adnexal mass less than 35 mm with cardiac activity or less than 40 mm without cardiac activity.
- •Patient is hemodynamically stable.
排除标准
- •Intrauterine pregnancy Beta HCG more than 5000 MIU/ML Ruptured ectopic pregnancy Unruptured ectopic pregnancy with significant pain.
结局指标
主要结局
To determine the resolution of ectopic pregnancy by estimating serum human chorionic gonadotropin (beta hCG) levels below 5mIU/mL
时间窗: 4th day of administration of either drug followed by 7th day of administration. | If the decline between 4th and 7th day is more or equal to 15 percent then weekly monitoring of bhcg will be done till it comes down to less the 5 mIU/ml
次要结局
- To assess the changes in ovarian reserve antimullerian hormone AMH & hematologic changes (CBC, LFT)associated with the two medical treatments.(AMH, LFT AND CBC will be recorded on the following time points)
研究者
Meghasriti
Guwahati Medical College, Guwahati