The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.
研究概览
简要总结
The present study aims at studying the effect of letrozole in early pregnancy in placenta and decidua including the progesterone receptor and the apoptotic factors.
详细描述
Twenty healthy subjects requesting legal surgical abortion up to 63 days gestation will be recruited for this study. They will be randomized to receive either placebo tablets or letrozole 10 mg daily for 7 days before suction evacuation. Suction evacuates which include the placenta and some decidua collected by the procedure in these 20 subjects will be used for the laboratory studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The gestational age should be up to 63 days. An ultrasound assessment would be performed to confirm the gestation.
- •The woman is willing and able to participate after the study has been explained
- •Age >18 years old
排除标准
- •Criteria for prospective exclusion
- •Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should not be recruited if any of the following conditions is present:
- •multiple pregnancies
- •uterine fibroids
- •any significant medical disorder
- •intrauterine contraceptive device in situ
- •contra-indications to the use of letrozole or misoprostol
- •Criteria for exclusion from a secondary analysis
- •Situation in which subjects who have been formally admitted to the study could be excluded from a secondary analysis include:
- •the use of drugs other than those prescribed by the investigator for the treatment of possible therapy-related side-effects especially drugs with prostaglandin synthetase inhibitory activity such as salicylates, indomethacin or mefenamic acid
- •any violation of the study protocol
- •essential data missing from the subject's records making it impossible to judge the treatment outcome
研究组 & 干预措施
Letrozole group
Letrozole 10 mg daily for 7 days before suction evacuation
干预措施: Letrozole (Drug)
Placebo group
Placebo tablets (look identical to letrozole tablets) daily for 7 days before suction evacuation
干预措施: Placebo (Drug)
结局指标
主要结局
The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.
时间窗: 8 days
次要结局
- Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.(8 days)
研究者
Dr. Lee Chi Yan Vivian
Associate Consultant
Queen Mary Hospital, Hong Kong