A Prospective Observational Study of the Performance of Zarin in Kenya

This study is ongoing, but not recruiting participants.

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: June 26, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 11, 2011

Last Updated Date

June 26, 2012

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The cumulative probability of pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01334190 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Prospective Observational Study of the Performance of Zarin in Kenya

Official Title ^ICMJE

A Prospective Observational Study of the Performance of Zarin in Kenya

Brief 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.

Detailed Description

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

healthy women aged 18-44

Condition ^ICMJE

Contraceptive Usage

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Kenya

Administrative Information

NCT Number ^ICMJE

NCT01334190

Other Study ID Numbers ^ICMJE

10264

Has Data Monitoring Committee

Responsible Party

FHI 360

Study Sponsor ^ICMJE

FHI 360

Collaborators ^ICMJE

United States Agency for International Development (USAID)

Investigators ^ICMJE

Principal Investigator:

Vera Halpern, MD

FHI 360

Information Provided By

FHI 360

Verification Date

June 2012

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

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