A Prospective Observational Study of the Performance of Zarin in Kenya

FHI 360

Status: Completed

Conditions: Contraceptive Usage

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01334190

10264

Details and patient eligibility

About

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.

Full 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.

Enrollment: 602 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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