Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 551
- 试验地点
- 7
- 主要终点
- Complete abortions without surgical intervention
研究概览
简要总结
Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that "quickstart" of a LARC - i.e., inserting it during the surgical procedure - is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.
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 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women opting for medical abortion and post abortion Nexplanon
- •no contraindicated to medical abortion or Nexplanon (according to the SMPc) gestational length up to and including 63 days (determined with ultrasonography)
- •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 Nexplanon®
- •women with pathological pregnancies
研究组 & 干预措施
Etonorgestrel and mifepristone
Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion
干预措施: Mifepristone (Drug)
Etonorgestrel and mifepristone
Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion
干预措施: etonorgestrel (Drug)
mifepristone
Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion
干预措施: Mifepristone (Drug)
结局指标
主要结局
Complete abortions without surgical intervention
时间窗: at 3 weeks follow up
Efficacy of the medical abortion treatment
次要结局
- Unplanned pregnancy(during one year FU)
- Rate of implant insertion(up to 1year FU)
- Number of women with complications(evaluated at the 3weeks FU)
- Bleeding(Evaluated at 1 year FU)
研究者
Kristina Gemzell Danielsson
Professor
Karolinska Institutet
