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

Study Overview
=================
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.

Official Title
-----------------
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan

Conditions
-----------------
Contraception

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surveillance<br>- 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<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mg milligram(s), 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, mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range, WB Western Blot