Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease in β-hCG levels
研究概览
简要总结
The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG <5000 mIU/mL, ectopic mass <3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ectopic pregnancy according to the diagnostic criteria
- •Patients with β-hCG levels <5000 mIU/ml,
- •Patients without serious or persistent abdominal pain
- •Patients without fetal cardiac activity observed
- •Ectopic mass size smaller than 3-4 cm
- •Patients without contraindications for methotrexate and letrozole
排除标准
- •Ruptured ectopic pregnancies
- •Hemodynamically unstable patients
- •Patients with acute abdomen or intra-abdominal bleeding
- •Patients with fetal cardiac activity
- •β-hCG levels below 500 mIU/mL or above 5000 mIU/mL
- •Patients non-compliant with treatment
- •Ectopic pregnancy size over 40 mm
研究组 & 干预措施
Letrozole + Single-Dose Methotrexate Group
Patients in the MTX + letrozole group received letrozole tablets (Femara 2.5 mg) once daily for ten days starting from the day of MTX administration.
干预措施: Letrozole (Drug)
Single-Dose Methotrexate
After confirming the diagnosis of tubal ectopic pregnancy, each patient received a single dose of intramuscular MTX (50 mg/m² MTX) on the same day.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Decrease in β-hCG levels
时间窗: On day 1, 4 and 7
Serum β-hCG titration was monitored on days 1, 4, and 7 using the same laboratory kit.
次要结局
- Hospitalization Days(Through study completion, an average of 3 weeks)
- Need of surgical interventions(On the days of admission.)
研究者
Metin Ayğar
Principal Investigator
Yuzuncu Yıl University