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临床试验/CTRI/2025/12/098379
CTRI/2025/12/098379尚未招募不适用

A study to evaluate the efficacy, safety and pharmacokinetics of Methotrexate in unruptured tubal ectopic pregnancy

Department Of Pharmacology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1

研究概览

简要总结

Study Design: Prospective, open label study

Study Site:  Study participants will be recruited from the septic labor room of the Department of Obstetrics and Gynecology, PGIMER Chandigarh. The blood sample will be processed and analysed at the Department of Pharmacology PGIMER Chandigarh. Patients will be recruited after getting approval from the ethics committee.

Study Population: All the patients of unruptured tubal ectopic pregnancy will be screened and selected as per the predefined inclusion and exclusion criteria and recruited patients will be given complete information regarding the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • 1.Treatment naïve unruptured tubal ectopic pregnancy.
  • 2.Hemodynamically stable patient 3.No contraindications to Methotrexate.
  • 4.Willingness to give informed written consent.

排除标准

  • 1.Ruptured ectopic pregnancy 2.Signs of hemodynamic instability.
  • 3.Contraindication to methotrexate 4.Pre-existing hepatic/renal dysfunction, immunodeficiency, or hypersensitivity to MTX 5.Patient who has already received methotrexate from outside 6.Patient who are not willing to give consent for the study.
  • 7.Chronic ectopic pregnancy.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Lekha Saha

PGIMER Chandigarh

研究点 (1)

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