A Prospective Observational Study of the Performance of Zarin in Kenya
NCT ID: NCT01334190
Last Updated: 2013-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
602 participants
OBSERVATIONAL
2011-06-30
2013-02-28
Brief Summary
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* 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.
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Detailed Description
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* 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
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
44 Years
FEMALE
Yes
Sponsors
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United States Agency for International Development (USAID)
FED
FHI 360
OTHER
Responsible Party
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Principal Investigators
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Vera Halpern, MD
Role: PRINCIPAL_INVESTIGATOR
FHI 360
Locations
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FHI
Nairobi, Nairobi County, Kenya
Countries
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Other Identifiers
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10264
Identifier Type: -
Identifier Source: org_study_id
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