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

FHI 360

Status: Completed

Conditions: Contraception

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01463254

10231

Details and patient eligibility

About

This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.

Full 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.

Enrollment: 724 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

724 participants in 2 patient groups

Surveillance

Description:

- 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

Description:

a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment