Early Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion- a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Expulsion
研究概览
简要总结
Today a large proportion of early abortions are medical, in accordance to the woman's choice. The main objective of the present study was to compare, in a randomised fashion, initiation of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion with regard to expulsions and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age above 18
- •elective medical abortion up to 9 weeks (63 days) of amenorrhea
- •general good health and
- •good understanding of Swedish language.
排除标准
- •pathological pregnancies or abnormality of the uterus
- •complications after the medical abortion, such as on-going pregnancy retained gestational sac or endometritis
研究组 & 干预措施
Delayed IUC insertion
Patients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment
干预措施: Timing of IUC insertion (Other)
Early IUC insertion
Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment.
干预措施: Timing of IUC insertion (Other)
结局指标
主要结局
Expulsion
时间窗: 6 months after IUC insertion
Expulsions are recorded up to 6 months after the IUC insertion
次要结局
- PID(within 6 months of IUC insertion)
- serum hemoglobin(4 weeks post IUC insertion)
- Compliance(6 months)
- Bleeding patterns(4 weeks)
研究者
Kristina Gemzell Danielsson
Professor, Head of Department
Karolinska Institutet