A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar

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.

Study Overview

• Status: Completed
• Conditions: Long-term and Permanent Contraceptive Methods

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.

• Study Type: Observational
• Enrollment (Actual): 621

Contacts and Locations

Study Locations

• Madagascar
  • Madagascar, Madagascar
    • Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

healthy women of any age

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Bill and Melinda Gates Foundation; Marie Stopes International
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• 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
• Other Study ID Numbers: 10225