Effectiveness of Oral Versus Vaginal Misoprostol Before Office Hyteroscopy in Infertile Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- level of pelvic pain according to a 10-point visual analogue scale (VAS)
研究概览
简要总结
The role of hysteroscopy in infertility investigation is to detect possible intrauterine changes that could interfere with implantation or growth or both of the conceptus, with the invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention. It is currently acknowledged as the 'gold standard' investigation of the intrauterine abnormalities.
Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force needed for dilation, thereby potentially reducing the probability of procedural complication such as uterine perforation, cervical laceration, failure to dilate, and creation of a false track that can occur during cervical entry.
Misoprostol is a prostaglandin El analogue, that can be administered either orally or vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis of proteoglycans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged from 20 to 40 years old.
- •They are complaining with primary or secondary infertility.
- •They undergo investigations including husband semen analysis, hormonal assay, U/S, Hystrosalpingography.
排除标准
- •Known sensitivity to misoprostol.
- •Any systemic disease contraindicating the use of prostaglandins (cardiovascular disease, hypertension, renal failure, etc).
- •Concomitant neurologic disease that could affect the correct evaluation of pain.
- •Pregnancy.
- •Any contraindication to hysteroscopy such as Pelvic inflammatory disease (PID).
- •Heavy uterine bleeding.
- •Any uterine abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.
研究组 & 干预措施
Oral Misoprostol
oral misoprostol ( prostaglandins E1 analogue) will be administered at a dose of 600 µg (200 µg every 8 hours), starting 24 hours before office hysteroscopy.
干预措施: Misoprostol , Prostaglandins E1 analogue (Drug)
Vaginal Misoprostol
vaginal misoprostol ( prostaglandins E1 analogue)will be administered at a dose of 400 µg (200 µg 12 hours apart, starting 24 hours before office hysteroscopy)
干预措施: Misoprostol , Prostaglandins E1 analogue (Drug)
结局指标
主要结局
level of pelvic pain according to a 10-point visual analogue scale (VAS)
时间窗: 10 months
The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS). The VAS will be applied immediately after the procedure ended
次要结局
未报告次要终点
研究者
Yomna Ali Bayoumi
Lecturer of Obstetrics and Gynecology
Kasr El Aini Hospital