A Prospective Observational Study of the Performance of Zarin in Kenya
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraceptive Usage
- Sponsor
- FHI 360
- Enrollment
- 602
- Locations
- 1
- Primary Endpoint
- The cumulative probability of pregnancy
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The cumulative probability of pregnancy
Time Frame: 1 year
Secondary Outcomes
- 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)