TO COMPARE EFFECT OF LETROZOLE VS METHOTREXATE FOR MEDICAL MANAGEMENT OF UNRUPTURED TUBAL ECTOPIC PREGNANCY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Ectopic pregnancy is a significant cause of maternal morbidity. Medical management is preferred in hemodynamically stable women with unruptured tubal ectopic pregnancy. Methotrexate is the standard medical treatment but may be associated with adverse effects and contraindications. Letrozole has been proposed as an alternative medical therapy.
This study is a randomized parallel group active controlled clinical trial conducted at a tertiary care hospital in India. Women with unruptured tubal ectopic pregnancy who are hemodynamically stable are randomized to receive either oral Letrozole or intramuscular Methotrexate.
The primary outcome is the change in serum beta human chorionic gonadotropin levels following treatment. Secondary outcomes include the need for surgical intervention and adverse effects related to the study drugs. The study is currently open to recruitment.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women diagnosed with unruptured tubal ectopic pregnancy.
- •Hemodynamically stable patients.
- •Serum beta human chorionic gonadotropin level less than or equal to 5000 milli international units per millilitre.
- •Mean sac diameter less than three point five centimetres with no fetal cardiac activity on transvaginal ultrasound.
- •Patients fulfilling criteria for medical management of unruptured ectopic pregnancy.
- •Patients willing and able to comply with post treatment follow up.
- •Patients having access to emergency medical services in case of clinical deterioration.
- •Patients with no contraindication to Methotrexate and Letrozole.
- •Patients who have provided written informed consent.
排除标准
- •Ruptured ectopic pregnancy or signs of impending rupture.
- •Hemodynamically unstable patients.
- •Heterotopic pregnancy with coexisting viable intrauterine pregnancy.
- •Pregnancy of unknown location.
- •Presence of fetal cardiac activity in ectopic pregnancy.
- •Serum beta human chorionic gonadotropin level more than 5000 milli international units per millilitre.
- •Ectopic mass size equal to or more than three point five centimetres.
- •Patients with abnormal liver renal or hematological function.
- •Patients with immunodeficiency states.
- •Patients with active pulmonary disease including tuberculosis.
- •Patients with peptic ulcer disease.
- •Patients with known hypersensitivity to Methotrexate or Letrozole.
- •Patients unwilling or unable to comply with follow up protocol.
研究者
Dr. Jidiya Chirag Harshadbhai
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL