A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Long-term and Permanent Contraceptive Methods
- Sponsor
- FHI 360
- Enrollment
- 621
- Locations
- 1
- Primary Endpoint
- Reasons for discontinuation
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.
Detailed Description
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.
Investigators
Eligibility Criteria
Inclusion Criteria
- •be a participant of the MSM service evaluation and continue using Zarin at 3 months
- •agree at the time of Zarin insertion to be contacted regarding an opportunity to participate in more research related to the implant
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reasons for discontinuation
Time Frame: 1 year
Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal
Time Frame: 1 year
The cumulative probability of pregnancy through one year
Time Frame: 1 year
Prevalence and incidence rate of adverse events
Time Frame: 1 year
The cumulative probability of early discontinuation through one year
Time Frame: 1 year