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临床试验/NCT01954069
NCT01954069已完成不适用

Simplifying Menstrual Regulation (MR): Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service Provision in Pakistan

Gynuity Health Projects11 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
280
试验地点
11
主要终点
Feasibility to determine successful completion of MR

研究概览

简要总结

The study seeks to test whether it is feasible and acceptable for both women and providers (in this context the Lady Health Visitor) to use the semi-quantitative pregnancy test (SQPT) as a tool for follow up after MR services. The study is planned at 11service delivery points (primary health clinics) in Punjab province where consenting women will be asked to take a baseline test at the clinic the morning they present for the MR procedure. Women will be asked to complete a second test at home the morning of their scheduled follow up visit and return to the clinic for follow-up care later that day. The results of the at home test will be compared to the baseline to determine the outcome of the MR. This is of particular importance because to-date no research has documented the accuracy of the test in detecting MR outcomes with misoprostol only regimens.

We hypothesize that women and providers will find the test easy and acceptable to use thereby improving follow up and simplifying MR service provision. In addition, the simple pictorial instructions will enable most women to use the test and interpret the results correctly on their own.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Eligible for medical menstrual regulation services according to clinic guidelines
  • Willing to follow instructions and use the SQPT at home
  • Agrees to return for a follow-up visit 7 days after receipt of misoprostol for the MR procedure

排除标准

  • Not eligible for medical menstrual regulation services according to clinic guidelines
  • Not willing to follow instructions and use the SQPT at home
  • Does not agree to return for a follow-up visit 7 days after receipt of misoprostol for the MR procedure

结局指标

主要结局

Feasibility to determine successful completion of MR

时间窗: 2 weeks

1. The proportion of woman for whom Human Chorionic Gonadotropin (hCG) remains the same after MR 2. The proportion of woman for whom hCG remains increases after MR 3. The proportion of woman for whom hCG declines after MR 4. Any additional care received by women in each of the above groups (1-3) will also be described

次要结局

  • Confidence in test(2 weeks)
  • Selecting and receiving family planning method(2 weeks)
  • Comprehension of pregnancy test(2 weeks)

研究者

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

研究点 (11)

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