A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
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Purpose
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.
| Condition |
|---|
|
Long-term and Permanent Contraceptive Methods |
| Study Type: | Observational |
| Official Title: | A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar |
- The cumulative probability of pregnancy through one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Prevalence and incidence rate of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The cumulative probability of early discontinuation through one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Reasons for discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 621 |
| Study Start Date: | October 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
healthy volunteers
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
healthy women of any age
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:
-
Contacts and Locations| Madagascar | |
| Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics | |
| Madagascar, Madagascar | |
| Principal Investigator: | Odile Hanitriniaina, MD | Marie Stopes International |
| Study Chair: | Kristen Hopkins | Marie Stopes International |
| Principal Investigator: | Tania Boler | Marie Stopes International |
| Principal Investigator: | Markus Steiner, Ph.D. | FHI 360 |
More Information
No publications provided
| Responsible Party: | FHI 360 |
| ClinicalTrials.gov Identifier: | NCT01200576 History of Changes |
| Other Study ID Numbers: | 10225 |
| Study First Received: | September 10, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Institutional Review Board Madagascar: Ministry of Health |
Keywords provided by FHI 360:
|
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 |
ClinicalTrials.gov processed this record on June 13, 2013