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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463254
• Other study ID #: 10231
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: July 11, 2013
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
Pakistan	Marie Stopes Society clinics	Pakistan

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy	measure number of pregnancies while using implant	12 months	No
Primary	Immediate and Delayed Complications	Measure Immediate and delayed complications associated with insertion or removal of implant	12 months	Yes
Primary	Adverse events	to record any adverse events associated with the implant	12 months	Yes
Primary	Measure number of participants who discontinue from the study	Measure number of participants who discontinue from the study and the reasons for discontinuation	12 months	No