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.

Study Overview

• Status: Completed
• Conditions: Contraception

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 Type: Observational
• Enrollment (Actual): 724

Contacts and Locations

Study Locations

• Pakistan
  • Pakistan, Pakistan
    • Marie Stopes Society clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

women using Femplant as a primary method of contraception in Pakistan

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy	measure number of pregnancies while using implant	12 months
Immediate and Delayed Complications	Measure Immediate and delayed complications associated with insertion or removal of implant	12 months
Adverse events	to record any adverse events associated with the implant	12 months
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

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: United States Agency for International Development (USAID)
• Investigators: Study Director: Paul Feldblum, PhD, FHI 360; Principal Investigator: Syed Khurram Azmat, MD, Marie Stopes Society, Pakistan; Study Chair: Adrienne Testa, Marie Stopes Internatioanl

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): July 15, 2013
• Last Update Submitted That Met QC Criteria: July 11, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot; IU international units; Femplant
• Other Study ID Numbers: 10231 (Other Identifier: CTEP)