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A Prospective Observational Study of the Performance of Zarin in Kenya

NCT01334190 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 602

Last updated 2013-07-02

No results posted yet for this study

Summary

This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and
* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Conditions

  • Contraceptive Usage

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • FHI 360

    lead OTHER

Principal Investigators

  • Vera Halpern, MD · FHI 360

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01334190 on ClinicalTrials.gov