A Prospective Observational Study of the Performance of Zarin in Kenya

Completed

• Conditions: Contraceptive Usage

• Registration Number: NCT01334190
• Lead Sponsor: FHI 360

Brief Summary

This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and

* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Detailed Description

A non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and

* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Study Timeline

• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Study Start: 2011-06
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 602

Inclusion Criteria

• be aged 18-44 years, inclusive
• be willing to sign an informed consent document
• be willing to give contact information for follow up
• agree to return for follow-up visits
• have decided to receive Zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cumulative probability of pregnancy	1 year

Secondary Outcome Measures

Name	Time	Method
Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal	1 year
Prevalence and incidence rate of adverse events	1 year
The cumulative probability of early discontinuation of Zarin through one year	1 year
Reasons for discontinuation	1 year
Level of women's satisfaction with Zarin services	1 year

Trial Locations

Locations (1)

FHI; 🇰🇪 Nairobi, Kenya