Management of Tubal Pregnancy With Off-label Use of Letrozole in Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The effectiveness of the treatment
研究概览
简要总结
It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (MTX) in women refusing surgery. The aim was to compare the effectiveness of letrozole with MTX in the management of tubal pregnancy.
详细描述
A prospective cohort study is conducted among women with tubal pregnancy. Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included.
Two study arms were planned:
i) women treated with MTX: MTX in a single dose of 100 mg intravenously on day 0; ii) women treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0.
The inclusion criteria included B-hCG concentration up to 3000 mIU/ml and no contraindications to conservative treatment. Women who did not meet criteria for conservative treatment were excluded. Blood parameters (B-hCG, hemoglobin, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7. Cases of treatment failure were counted, i.e. the need to perform laparoscopy due to tubal pregnancy rupture, pain, increase in B-hCG concentration.
The women were given the option to choose the treatment used in the study. All enrolled women gave informed written consent to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •tubal pregnancy confirmed on pelvic ultrasound
- •increasing serum B-hCG concentrations in at least two subsequent measures
- •serum B-hCG concentration ≤ 3000 mIU/ml
排除标准
- •free fluid in lesser pelvis on pelvic ultrasound
- •positive fetal heartbeat on pelvic ultrasound
- •abdominal pain
- •heterotopic pregnancy
- •contraindications to MTX
研究组 & 干预措施
Tubal pregnancy treated with MTX
MTX in a single dose of 100 mg intravenously on day 0
干预措施: MTX as monotherapy (Drug)
Tubal pregnancy treated with letrozole
Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0
干预措施: Letrozole as monotherapy (Drug)
结局指标
主要结局
The effectiveness of the treatment
时间窗: up to 6 months
Conversion rate to laparoscopy due to tubal rupture, pain, serum B-hCG increase in the course of treatment
次要结局
- The effect of treatment on bone marrow function (hemoglobin)(up to 6 months)
- The effect of treatment on bone marrow function (white blood cells)(up to 6 months)
- The effect of treatment on liver function (alanine transaminase)(up to 6 months)
- The effect of treatment on bone marrow function (red blood cells)(up to 6 months)
- The effect of treatment on bone marrow function (platelets)(up to 6 months)
- The effect of treatment on liver function (total bilirubin)(up to 6 months)
- The effect of treatment on liver function (gamma-glutamyltransferase)(up to 6 months)
- The effect of treatment on liver function (aspartate transaminase)(up to 6 months)
- The effect of treatment on kidney function (urea)(up to 6 months)
- The effect of treatment on kidney function (creatinine)(up to 6 months)
研究者
Iwona Magdalena Gawron
M.D., Ph.D., Principal Investigator
Jagiellonian University