Evaluation of the Therapeutic Effect of Adding Letrozole to the Protocol of Combined Treatment of Cesarean Scar Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Blood loss volume during the procedure expressed in volume units
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. There is no reference treatment of cesarean scar pregnancy (CSP) as the limited number of cases precludes the extrapolation of results. In our center we successfully use two-step treatment with methotrexate (MTX) followed by hysteroscopic removal of products of conception (POC). The time in between is needed to achieve a decrease in the trophoblast's vital potential (B-hCG fall) and its vascularization. Additional administration of letrozole could further reduce the vital potential of the pregnancy, eliminating the need for another dose of MTX, resulting in faster healing and lower rate of complications.
详细描述
A prospective cohort study is conducted among women with cesarean scar pregnancy (CSP). Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included.
Two study arms were planned:
- women treated with a single dose of 100 mg MTX intravenously and 50 mg MTX in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH)
- women treated with a single dose of 100 mg MTX intravenously and 50 mg MTX in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH) with additional use of letrozole 5 mg orally (from day 0) for 10 days.
Blood parameters (B-hCG, hemoglobin, total blood count, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7, followed by B-hCG concentration measurement every 7 days until surgery. After obtaining satisfactory decrease in B-hCG and POC vascularization, women underwent hysteroscopic evacuation of POC. Blood loss parameters, frequency of conversion from hysteroscopy to laparoscopy and laparotomy were measured.
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
- •CSP confirmed on pelvic ultrasound
- •consent of the Bioethics Committee for termination of CSP
- •increasing B-hCG concentrations
排除标准
- •heterotopic pregnancy
- •decreasing B-hCG concentrations
研究组 & 干预措施
MTX in monotherapy
Combined treatment with MTX followed by hysteroscopic evacuation of POC
干预措施: MTX monotherapy (Drug)
MTX + letrozole add-on
Combined treatment with MTX + letrozole add-on followed by hysteroscopic evacuation of POC
干预措施: MTX + letrozole add-on (Drug)
结局指标
主要结局
Blood loss volume during the procedure expressed in volume units
时间窗: up to 6 months
The volume of blood lost during the procedure in ml
Conversion rate from hysteroscopy to laparoscopy or laparotomy due to due to hemorrhage
时间窗: up to 6 months
Percentage (%) of conversion from hysteroscopy to laparoscopy or laparotomy due to hemorrhage
Blood loss during the procedure expressed as a decrease in hemoglobin concentration
时间窗: up to 6 months
Decrease in hemoglobin concentration in g/dl on day 1 after the procedure compared to the pre-procedure concentration
次要结局
- The effect of treatment on bone marrow function (red blood cells)(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 liver function (aspartate transaminase)(up to 6 months)
- The effect of treatment on liver function (gamma-glutamyltransferase)(up to 6 months)
- The effect of treatment on bone marrow function (platelets)(up to 6 months)
- The effect of treatment on liver function (serum total bilirubin)(up to 6 months)
- The effect of treatment on kidneys function (urea)(up to 6 months)
- The effect of treatment on kidneys function (creatinine)(up to 6 months)
研究者
Iwona Magdalena Gawron
M.D., Ph.D., Principal Investigator
Jagiellonian University