NCT01334190

A Prospective Observational Study of the Performance of Zarin in Kenya

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 602 (actual)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraceptive Usage

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-04-13
• Last updated: 2013-07-02

Locations

1 site across 1 country: Kenya