Clinical trial NCT01200576: A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
Official title: A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long-term and Permanent Contraceptive Methods
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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Marie Stopes International
First posted: 2010-09-13
Enrollment: 621
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: healthy women of any age

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.

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:

-

Primary outcomes:
measure: The cumulative probability of pregnancy through one year
timeFrame: 1 year
measure: Prevalence and incidence rate of adverse events
timeFrame: 1 year
measure: Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal
timeFrame: 1 year
measure: The cumulative probability of early discontinuation through one year
timeFrame: 1 year
measure: Reasons for discontinuation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madagascar
country: Madagascar
facility: Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics
Study officials:
affiliation: Marie Stopes International
name: Odile Hanitriniaina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes International
name: Kristen Hopkins
role: STUDY_CHAIR
affiliation: Marie Stopes International
name: Tania Boler
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360
name: Markus Steiner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: