A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
NCT ID: NCT01463254
Last Updated: 2013-07-15
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
724 participants
OBSERVATIONAL
2011-10-31
2013-02-28
Brief Summary
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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 enrolment; and
* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment 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 Femplant services.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Surveillance
\- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant
No interventions assigned to this group
Prospective
a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* be aged 18-44 years, inclusive
* be willing to sign an informed consent document
* agree to return for follow-up visits
* have decided to receive Femplant 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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Paul Feldblum, PhD
Role: STUDY_DIRECTOR
FHI 360
Syed Khurram Azmat, MD
Role: PRINCIPAL_INVESTIGATOR
Marie Stopes Society, Pakistan
Adrienne Testa
Role: STUDY_CHAIR
Marie Stopes Internatioanl
Locations
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Marie Stopes Society clinics
Pakistan, Pakistan, Pakistan
Countries
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Other Identifiers
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10231
Identifier Type: -
Identifier Source: org_study_id
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