NCT00572819已完成3 期
Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?
Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.
研究概览
简要总结
The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.
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
- Triple (Participant, Care Provider, Investigator)
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
- •All postmenopausal (> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment
排除标准
- •Women who do not wish to participate
- •Women who are medically unfit for hysteroscopy
- •Women who are medically unfit for participation in any clinical trial
- •Women who do not have a medical indication for hysteroscopy
- •Women who have previously had, or currently have breast or gynaecological cancer
- •Women who have a medical contraindication for locally applied oestradiol
- •Women who are currently using hormone therapy
- •Women who are unable to communicate in Norwegian, and
- •Women with a known allergy to misoprostol
研究组 & 干预措施
Misoprostol
Active Comparator
干预措施: Misoprostol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.
时间窗: 24 hours
次要结局
- Difference between baseline cervical dilatation at recruitment and preoperative dilatation.(14 days)
- Women with cervical dilatation ≥ 5 mm.(14 days)
- Acceptability.(14 days)
- Number of dilatations judged as "difficult."(14 days)
- Frequency of complications.(14 days)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Misoprostol For Nulliparous Women Before HysteroscopyCervical RipeningNCT01156948Wenzhou Medical University120
已完成
3 期
Hysteroscopy and Misoprostol ProjectUterine HemorrhageNCT00363389Ullevaal University Hospital86
已完成
4 期
Vaginally Administered Versus Per Oral Misoprostol in Induction of LabourLabour InductionNCT02539199Tampere University Hospital270
招募中
3 期
Survey of the effect of vaginal misoprostol on post myomectomy bleedingIRCT20220101053581N1Gorgan University of Medical Sciences68
尚未招募
不适用
Assessing the vaginal tablet - Misoprostol and Placebo(drug without any action) for dilatation of cervix before hysteroscopy(procedure where camera inserted into uterus through vagina to carry out small surgeries) using small size instrument-mini resectoscopeCTRI/2022/11/047611Jawaharlal Institute of Postgraduate Medical Education and Research