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Completed

NCT Number: NCT01463254

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.

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Key information

Conditions

Contraception Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Marie Stopes Society clinics

Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. pregnancy

    Time frame: 12 months

    measure number of pregnancies while using implant

  2. Immediate and Delayed Complications

    Time frame: 12 months

    Measure Immediate and delayed complications associated with insertion or removal of implant

  3. Adverse events

    Time frame: 12 months

    to record any adverse events associated with the implant

  4. Measure number of participants who discontinue from the study

    Time frame: 12 months

    Measure number of participants who discontinue from the study and the reasons for discontinuation

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 1, 2011
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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