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临床试验/CTRI/2014/12/005311
CTRI/2014/12/005311进行中(未招募)不适用

Impact of structured counselling with trained counselors: a retrospective analysis from a multi-centric project.

Organon India Private Limited4 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2013年3月18日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
351
试验地点
4
主要终点
To determine use rates of each contraceptives after counselling

研究概览

简要总结

It is a retrospective, non-interventional study. Retrospective design has been chosen since the project is already complete. Patient data collection forms which were collected during the project will be entered into the database for analysis. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 Inclusion criteria for analysis:

  • Women who underwent counselling during the project.  Although the estimated sample size is 170, the data of 351 women would be analyzed as all of them have undergone counselling during the project

Exclusion criteria:

  • Incomplete patient data collection forms

 Individual patient informed consent is not available and patient identifying information was neither inquired, nor documented. However, this study will be initiated post approval from Independent ethics committee.

Outcome measures

The following outcome measures will be evaluated.

Primary end point:

  • Comparison of proportion of women choosing one of the modern contraceptive after counseling with their past contraceptive history

Secondary end points:

  • Proportion of women opting for any of the contraceptives after counselling

Proportion of women opting each of the modern contraceptives after counselling in different profile of women (post abortion, post-partum and general group [without post-partum and post-partum])

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Retrospective analysis of the data on contraceptive method chosen after women in the reproductive age who desired contraception were counselled.

排除标准

  • Women who did not desire contraception and women whose data could not be captured.

结局指标

主要结局

To determine use rates of each contraceptives after counselling

时间窗: Will be assessed only once post the counselling session with the counselor

To compare the adopted modern contraceptive method post counselling with past contraceptives ever used

时间窗: Will be assessed only once post the counselling session with the counselor

To determine use rates of each modern contraceptives after counselling in different profile of women (post-partum, post-abortion and general)

时间窗: Will be assessed only once post the counselling session with the counselor

次要结局

  • To determine use rates of each modern contraceptives after counselling in different profile of women (post-partum, post-abortion and general)(once only post couneseling)

研究者

发起方
Organon India Private Limited
申办方类型
Pharmaceutical industry-Indian

研究点 (4)

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