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Clinical Trials/CTRI/2014/12/005311
CTRI/2014/12/005311Active, not recruitingNot Applicable

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

Organon India Private Limited4 sites in 1 country351 target enrollmentStarted: March 18, 2013Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
351
Locations
4
Primary Endpoint
To determine use rates of each contraceptives after counselling

Study Overview

Brief Summary

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])

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

To determine use rates of each contraceptives after counselling

Time Frame: 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

Time Frame: 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)

Time Frame: Will be assessed only once post the counselling session with the counselor

Secondary Outcomes

  • 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)

Investigators

Sponsor
Organon India Private Limited
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (4)

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