Medical Abortion up to 10 Weeks Gestation at Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Number of incomplete abortions
研究概览
简要总结
Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation.
详细描述
The study will include 600 women opting for medical abortion. Women wanting to perform the last part of the abortion in their homes will be invited to participate. 300 women with a pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation length between 64 and 70 days of gestation. The primary endpoints will be number of patients with an incomplete abortion, with a need for surgical or pharmaceutical intervention.
Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method and number of additional visits to the clinic/facility.
The study will be performed in five abortion clinics in Sweden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Requesting and eligible for medical abortion
- •Confirmed intrauterine pregnancy
- •Gestational length no more than 70 days
- •Hemoglobin over 100g/l
排除标准
- •Contraindication to mifepristone (steroid-dependant cancer, porphyria)
- •Breast feeding
- •Advanced pregnancy (>70 days)
- •Known liver disease
- •Bleeding disorder
- •Arterial hypertension
结局指标
主要结局
Number of incomplete abortions
时间窗: 4 weeks after treatment
Need for surgical or pharmaceutical intervention
次要结局
- Acceptance and satisfaction of treatment(4 weeks after treatment)
- Duration of bleeding(4 weeks after treatment)
- Number of additional visits to the clinic(4 weeks after treatment)
研究者
Lena Marions
Associate professor, senior consultant
Karolinska Institutet