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Study Protocol

Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant) in Pakistan

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Pages 573-583 | Published online: 29 May 2014
 

Abstract

Introduction

The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant) in Pakistan during the first year of its use among married women of reproductive age (18–44 years) at clinics in two provinces of Pakistan (Sindh and Punjab).

Materials and methods

A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization) in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility.

Discussion

Over the next 5-year period (2013–2018), 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end users with Femplant (Sino-implant II). This will help to guide policies to enhance access to and the use of long-acting contraceptive implants in Pakistan and similar developing countries.

Acknowledgments

The study was funded by the US Agency for International Development (USAID) under the terms of Cooperative Agreement GPO A 00 08 00001-00, Program Research for Strengthening Services (PROGRESS). The contents are the responsibility of FHI 360 and Marie Stopes International, and do not necessarily reflect the views of USAID or the US government. We are grateful for the contributions of Marie Stopes International staff, Marie Stopes Society Pakistan staff, the FHI 360 Data Management and Biostatistics teams, and the study participants for their time and dedication to this project.

Disclosure

The authors report no conflicts of interest in this work.