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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
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This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. It will be conducted in close collaboration with the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie Stopes Society clinics that have experience with implants and sufficient expected flow of implant users per month. We will enroll a total of 600 women divided into two cohorts in this one-year prospective study:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| Prospective | a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| pregnancy | measure number of pregnancies while using implant | 12 months |
| Immediate and Delayed Complications | Measure Immediate and delayed complications associated with insertion or removal of implant | 12 months |
| Adverse events | to record any adverse events associated with the implant | 12 months |
| Measure number of participants who discontinue from the study | Measure number of participants who discontinue from the study and the reasons for discontinuation | 12 months |
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Inclusion Criteria:
To be eligible for inclusion, a woman must:
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women using Femplant as a primary method of contraception in Pakistan
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| Name | Affiliation | Role |
|---|---|---|
| Paul Feldblum, PhD | FHI 360 | Study Director |
| Syed Khurram Azmat, MD | Marie Stopes Society, Pakistan | Principal Investigator |
| Adrienne Testa | Marie Stopes Internatioanl | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marie Stopes Society clinics | Pakistan | Pakistan | Pakistan |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |