Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Prospective Observational Study of the Performance of Zarin in Kenya

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01334190
First received: April 11, 2011
Last updated: July 1, 2013
Last verified: July 2013

April 11, 2011
July 1, 2013
June 2011
February 2013   (final data collection date for primary outcome measure)
The cumulative probability of pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01334190 on ClinicalTrials.gov Archive Site
  • Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence and incidence rate of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The cumulative probability of early discontinuation of Zarin through one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Reasons for discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Level of women's satisfaction with Zarin services [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Prospective Observational Study of the Performance of Zarin in Kenya
A Prospective Observational Study of the Performance of Zarin in Kenya

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.

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.

Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample

healthy women aged 18-44

Contraceptive Usage
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
602
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • be aged 18-44 years, inclusive
  • be willing to sign an informed consent document
  • be willing to give contact information for follow up
  • agree to return for follow-up visits
  • have decided to receive Zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception
Female
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01334190
10264
No
FHI 360
FHI 360
United States Agency for International Development (USAID)
Principal Investigator: Vera Halpern, MD FHI 360
FHI 360
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP