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

• 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

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.

women using Femplant as a primary method of contraception in Pakistan

• 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

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