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临床试验/NCT02720991
NCT02720991已完成4 期

A Pilot Study of the Acceptability and Feasibility of an Out-patient Regimen of Medical Abortion With Mifepristone and 400 mcg Sublingual Misoprostol at 71-77 and 78-84 Days Gestation

Gynuity Health Projects0 个研究点目标入组 50 人开始时间: 2014年7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
发起方
入组人数
50
主要终点
Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire

研究概览

简要总结

A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.

详细描述

The study will enroll 25 women in each gestational age group. All participants will be submitted to routine screening as per current practice at La Rabta Hospital. The eligible women will receive a dose of 200 mg of mifepristone and 400 ug of misoprostol to take at home sublingually .

The first 5 women enrolled in each gestational age group will be asked to return to the clinic 24-48 hours after the initial visit to take misoprostol at the clinic and wait during a 3 hour observational period before returning to their homes. After this initial phase, the women will be asked to self-administer the misoprostol at home 24-48 hours after the administration of mifepristone and to return to the clinic 7-10 days later. At follow-up, a healthcare provider will assure her that her medical abortion is complete and after will ask women to respond to a series of questions in an exit interview.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Gestational age of 71-84 days of amenorrhea
  • Seeking abortion services
  • Prepared and able to sign the consent forms
  • Accept to conform to study procedures and scheduled visits

排除标准

  • Does not meet study criteria

研究组 & 干预措施

Mifepristone and sublingual misoprostol

Experimental

200 mg mifepristone and 400 ug sublingual misoprostol

干预措施: Mifepristone (Drug)

Mifepristone and sublingual misoprostol

Experimental

200 mg mifepristone and 400 ug sublingual misoprostol

干预措施: Sublingual misoprostol (Drug)

结局指标

主要结局

Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire

时间窗: 1 week

次要结局

  • Level of tolerance of side effects, based on responses to questionnaire(1 week)

研究者

发起方
Gynuity Health Projects
申办方类型
Other
责任方
Sponsor

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