A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan

This study has been completed.
Sponsor:
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: July 11, 2013
Last verified: July 2013

October 13, 2011
July 11, 2013
October 2011
February 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01463254 on ClinicalTrials.gov Archive Site
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A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan

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:

  • 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.

Observational
Time Perspective: Prospective
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Probability Sample

women using Femplant as a primary method of contraception in Pakistan

Contraception
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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
  • Prospective
    a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
724
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01463254
10231
No
FHI 360
FHI 360
United States Agency for International Development (USAID)
Study Director: Paul Feldblum, PhD FHI 360
Principal Investigator: Syed Khurram Azmat, MD Marie Stopes Society, Pakistan
Study Chair: Adrienne Testa Marie Stopes Internatioanl
FHI 360
July 2013

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