Medical Termination of Pregnancy From Day 85 to Day 153 of Gestation: A Randomized Comparison Between Administration of the Initial Dose of Misoprostol at Home or in the Clinic
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 8
- 主要终点
- Number of women treated as day care patients
研究概览
简要总结
The objective of this study is to compare two groups of women requiring termination of pregnancy from the gestational age of 85 days. All women will receive Mifepristone during their first visit to the out-patient ward. One group of women will receive Misoprostol to administer the first dose (vaginally) at home and 2 hours later they will be admitted to the in-patient ward. They will be informed to present earlier if they start bleeding or experience pain corresponding to more than normal menstrual cramping.
The other group will receive the first dose of Misoprostol (vaginally) when admitted in the in-patient ward (usually in the morning) according to current practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Women aged >/= 18 years requesting a termination of pregnancy, for social, medical or foetal indications
- •gestational age 85 - 153 days (with ultrasonography),
- •willing and able to understand and participate after the study has been explained, with good understanding of Swedish or English language,
- •general good health,
- •single intra-uterine pregnancy,
排除标准
- •do not wish to participate or unable to communicate in Swedish or English.
- •non-viable pregnancy (confirmed by ultrasonography).
- •a history or evidence of disorders that represent a contraindication to the use of Mifepristone or Misoprostol (adrenal pathology, steroid dependent cancer, porphyria, known allergy to the medication).
- •any pre-existing health conditions for whom the execution of a medical abortion as judged by the investigator could compromise their condition (Examples of health conditions of concern are: severe anaemia, severe asthma, haemorrhagic disorders, treatment with anticoagulants or corticoids, severe cardiac disease or hypertension, severe liver disease, severe kidney disease or severe psychiatric disorders).
- •Fetal malformation that may impact time-to-expulsion (such as hydrocephalus, hydrops/edema) or a duplex pregnancy.
结局指标
主要结局
Number of women treated as day care patients
时间窗: 9 hours from admission to the out patient clinic
No overnight hospitalization required.
次要结局
- induction-to-abortion interval(From first dose of misoprostol until the expulsion of the foetus or surgical intervention whichever comes first assessed up to 7 days of induction)
- Surgical intervention(From the administration of mifepristone until 2 weeks FU)
- Painscores(From the administration of mifepristone until 2 weeks FU)
- Time spent in hospital(From admission until discharge up to 2 weeks FU)
- Administration of misoprostol(From the first dose to the last dose until 2 weeks FU)
- ncidence of Treatment-Emergent Adverse Events [Safety and Tolerability(From the administration of mifepristone until 2 weeks FU)
- Dose of misoprostol(From the first dose to the last dose until 2 weeks FU)
- the success rate of the termination of pregnancy at 24 hours(At 24 hours from first dose of misoprostol)
- Acceptability(At follow up two weeks after abortion)
研究者
Kristina Gemzell Danielsson
Professor, Överläkare
Karolinska Institutet