Sublingual Versus Vaginal Misoprostol for Cervical Dilatation 1 or 3 Hours Prior to Surgical Abortion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Force needed for cervical dilatation
研究概览
简要总结
Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women opting for first trimester surgical abortion
- •nulliparous
- •able and willing to provide informed consent
排除标准
- •unwilling to participate,
- •unable to communicate in Swedish and English and
- •minors (i.e. women < 18 years of age),
- •contraindications to misoprostol
- •women with pathological pregnancies
研究组 & 干预措施
Misoprostol sublingual,1h
Administration of misoprostol sublingually 1h prior to surgery
干预措施: Misoprostol sublingual, 1h (Drug)
Misoprostol sublingual,1h
Administration of misoprostol sublingually 1h prior to surgery
干预措施: Placebo vaginal, 1h (Drug)
Misoprostol sublingual. 3h
Administration of misoprostol sublingually 3h prior to surgery
干预措施: Misoprostol sublingual, 3h (Drug)
Misoprostol sublingual. 3h
Administration of misoprostol sublingually 3h prior to surgery
干预措施: Placebo vaginal, 3h (Drug)
Misoprostol vaginal,1h
Administration of misoprostol vaginally 1h prior to surgery
干预措施: Placebo sublingual,1h (Drug)
Misoprostol vaginal,1h
Administration of misoprostol vaginally 1h prior to surgery
干预措施: Misoprostol vaginal, 1h (Drug)
Misoprostol vaginal,3h
Administration of misoprostol vaginally 3h prior to surgery
干预措施: Misoprostol vaginal, 3h (Drug)
Misoprostol vaginal,3h
Administration of misoprostol vaginally 3h prior to surgery
干预措施: Placebo sublingual, 3h (Drug)
结局指标
主要结局
Force needed for cervical dilatation
时间窗: Measured at surgery
Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer. Force and time needed for the dilatation is recorded by the tonometer
次要结局
- Cervical diameter(Measured at surgery)
- Number of Participants with Adverse Events(Up to surgery)
研究者
Kristina Gemzell Danielsson
Professor
Karolinska Institutet