Contraception Clinical Trial
Official title:
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.
;
Time Perspective: Prospective
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