Routine Follow-up Versus Self-assessment of Complete Abortion Following Medical Abortion, Effect on Its Success and Acceptability: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 929
- 试验地点
- 5
- 主要终点
- Number of complete abortions
研究概览
简要总结
The main objective of the study is to optimize the routines for follow-up after medical abortion in order to give women more autonomy by reducing the number of consultations involved and to reduce the frequency of postabortal curettage.
This will be achieved by providing means for women for postabortal self-assessment with the use of a quantitative urinary hCG test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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 requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at < /=63 days of gestation, with no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent will be eligible for study recruitment.
排除标准
- •women who do not wish to participate
- •women who do not want home administration of misoprostol
- •women who are unable to communicate in Swedish, Norwegian, English, Finnish or German and women with symptoms and signs of ectopic pregnancy
- •minors (i.e. women < 18 years of age) will not be enrolled for the study.
- •women seeking termination of pregnancy with no sign of a visible intrauterine pregnancy (i.e. visible intrauterine yolk sac).
研究组 & 干预措施
Controls
Routine follow-up at the clinic 2-3 weeks after the treatment
Home self test
Intervention
干预措施: Home self assessment of complete medical abortion (Other)
结局指标
主要结局
Number of complete abortions
时间窗: Until 3 months post treatment
The primary objective is thus to demonstrate the non-inferiority of self-assessment of complete abortion following medical abortion compared to routine follow-up in terms of the percentage of women requiring surgical abortion, within a margin of non-inferiority of 5%.
次要结局
- adverse events(util 3 months post treatment)
- postabortion contraception(until 12 months post treatment)
研究者
Kristina Gemzell Danielsson
professor, MD, PhD
Karolinska Institutet