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

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01463254
First received: October 13, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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


Condition
Contraception

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • 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


Enrollment: 724
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

women using Femplant as a primary method of contraception in Pakistan

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463254

Locations
Pakistan
Marie Stopes Society clinics
Pakistan, Pakistan
Sponsors and Collaborators
FHI 360
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
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01463254     History of Changes
Other Study ID Numbers: 10231
Study First Received: October 13, 2011
Last Updated: July 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by FHI 360:
Femplant
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
IU international units
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

ClinicalTrials.gov processed this record on September 22, 2014