Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Live Birth Rate after 24 weeks of gestation
研究概览
简要总结
There is increasing amount of evidence which suggests that miscarriage is related to a primary endometrial problem. Recent cochrane meta-analysis (March 2015) has proven that endometrial scratch improves live birth in women who underwent IVF.
The aim of the study is to find out if scratch of the endometrium prevents recurrent miscarriage.
详细描述
The Warwick BRU-RH (Biomedical Research Unit- Reproductive Health) hypothesis is that failed pregnancies are the result of failed decidualisation of the endometrium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Actively trying for a pregnancy
排除标准
- •No active treatment in pregnancy
- •Inherited or acquired thrombophilia
- •Medical conditions- diabetes,hypertension,thyroid disorders
- •inability to tolerate internal examinations
- •uterine anomalies
- •Previous entry or randomisation in the present trial
研究组 & 干预措施
endometrial scratch
Patient will be randomised to the intervention arm which is the luteal phase endometrial scratch
干预措施: Endometrial scratch (Other)
touching cervix
Patient will have a speculum examination and cleaning of the cervix with cotton tip with saline but no scratch
干预措施: Touching the cervix (Other)
结局指标
主要结局
Live Birth Rate after 24 weeks of gestation
时间窗: from the recruitment of the first patient up to 12 months after the recruitment of last patient. the live birth rate of all the pregnant patients in the study who delivered after 24 weeks will be included in the outcome.
次要结局
- Miscarriage until 23+6 weeks of gestation(from the recruitment of the first patient and up to 12 months after the recruitment of last patient. the outcomes of all the pregnant patients in the study who delivered up to 23+6 weeks will be included in the outcome.)
- Acceptability of the intervention(Patient questionnaire will be issued at the time of randomisation. the returned forms up to 4 weeks after randomisation will be analysed and reported. this will be helpful for assessing the patients tolerability of the procedure)
- Pregnancy complications(from the recruitment of the first patient and up to 12 months after the recruitment of last patient. The patients who delivered after 24 weeks with a live birth will be included in the outcome and the described outcomes will be measured)