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临床试验/NCT01920022
NCT01920022已完成4 期

Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.

Karolinska Institutet7 个研究点 分布在 2 个国家目标入组 551 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion

干预措施: Mifepristone (Drug)

Etonorgestrel and mifepristone

Experimental

Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion

干预措施: etonorgestrel (Drug)

mifepristone

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Gemzell Danielsson

Professor

Karolinska Institutet

研究点 (7)

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