Long-term and Permanent Contraceptive Methods
Conditions
Keywords
CRF: Case Report Form, DM: Data Management, FHI: FHI (formerly known as Family Health International), IRB: Institutional Review Board, IUD: Intra-uterine Device, LTPM: Long-term and Permanent Contraceptive Methods, MSI: Marie Stopes International, MSM: Marie Stopes Madagascar, PHSC: Protection of Human Subjects Committee, PI: Principal Investigator, SAE: Serious Adverse Event, Sino-Implant (II), SOP: Standard Operating Procedure, Zarin
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.
Interventions
None listed
Sponsors
Bill and Melinda Gates Foundation
Marie Stopes International
FHI 360
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative probability of pregnancy through one year | 1 year |
| Prevalence and incidence rate of adverse events | 1 year |
| Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal | 1 year |
| The cumulative probability of early discontinuation through one year | 1 year |
| Reasons for discontinuation | 1 year |
Countries
Madagascar
Outcome results
None listed