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

Completed

• Conditions: Contraception

• Registration Number: NCT01463254
• Lead Sponsor: FHI 360

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-11
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 724

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pregnancy	12 months	measure number of pregnancies while using implant
Immediate and Delayed Complications	12 months	Measure Immediate and delayed complications associated with insertion or removal of implant
Adverse events	12 months	to record any adverse events associated with the implant
Measure number of participants who discontinue from the study	12 months	Measure number of participants who discontinue from the study and the reasons for discontinuation

Trial Locations

Locations (1)

Marie Stopes Society clinics; 🇵🇰 Pakistan, Pakistan