Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
详细描述
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body.Cervical ripening is made possible by the use of medication through different routes.The most commonly used agent is misoprostol,a synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
排除标准
- •• Nulliparous patients
- •patients with cervical pathology
- •retroverted uterus (detected by transvaginal ultrasound)
- •previous cervical surgery
- •patients with severe vaginal bleeding
- •allergy or contraindications to dinoprostone therapy (asthma, liver, kidney, or heart disease).
研究组 & 干预措施
dinoprostone arm
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
干预措施: Dinoprostone 3Mg Vaginal Tablet (Drug)
placebo
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
干预措施: placebo vaginal tablet (Drug)
结局指标
主要结局
Intensity of pain
时间窗: an expected average of 10 minutes
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
次要结局
- Intensity of pain(30 minutes after the procedure)
- Operative time(an expected average 10 minutes)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University