A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
This study is ongoing, but not recruiting participants.
Sponsor:
FHI 360
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01463254
First received: October 13, 2011
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
| Condition |
|---|
|
Contraception |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan |
Resource links provided by NLM:
Further study details as provided by FHI 360:
Primary Outcome Measures:
- pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]measure number of pregnancies while using implant
- Immediate and Delayed Complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Measure Immediate and delayed complications associated with insertion or removal of implant
- Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]to record any adverse events associated with the implant
- Measure number of participants who discontinue from the study [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measure number of participants who discontinue from the study and the reasons for discontinuation
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Detailed Description:
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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
women using Femplant as a primary method of contraception in Pakistan
Criteria
Inclusion Criteria:
To be eligible for inclusion, a woman must:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463254
Locations
| Pakistan | |
| Marie Stopes Society clinics | |
| Pakistan, Pakistan | |
Sponsors and Collaborators
FHI 360
United States Agency for International Development (USAID)
Investigators
| Study Director: | Paul Feldblum, PhD | FHI 360 |
| Principal Investigator: | Syed Khurram Azmat, MD | Marie Stopes Society, Pakistan |
| Study Chair: | Adrienne Testa | Marie Stopes Internatioanl |
More Information
No publications provided
| Responsible Party: | FHI 360 |
| ClinicalTrials.gov Identifier: | NCT01463254 History of Changes |
| Other Study ID Numbers: | 10231 |
| Study First Received: | October 13, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by FHI 360:
|
Femplant AE adverse event AIDS acquired immunodeficiency syndrome ALT (SGPT) alanine aminotransferase ART antiretroviral therapy AST (SGOT) aspartate aminotransferase DCF data collection forms DMC Data Monitoring Committee FDA (U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines HB sAg Hepatitis B surface antigen |
ICH International Conference of Harmonisation IND Investigational New Drug Application IRB Institutional Review Board IU international units mg milligram(s) mm3 cubic millimeter(s) PCR polymerase chain reaction SAE serious adverse event µg microgram ULN upper limit of the normal range WB Western Blot |
ClinicalTrials.gov processed this record on February 28, 2013
