Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant

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...

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Bibliographic Details
Published in:International journal of women's health 2014-01, Vol.6, p.573
Main Authors: Hameed, Waqas, Bilgrami, Mohsina, Siddiqui, Muhammad Ahmed, Ishaque, Muhammad, Mustafa, Ghulam, Lendvay, Anja, Hussain, Wajahat, Karim, Asif, Shaikh, Babar Tasneem, Brohi, Sajid, Feldblum, Paul J, Azmat, Syed Khurram
Format: Article
Language:English
Subjects:
Clinical trials
Contraceptive drug implants
Methods
Observational studies
Patient outcomes
Online Access:Get full text
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Summary: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. Keywords: safety, efficacy, acceptability, implant, Femplant, contraception, family planning, Pakistan
ISSN:1179-1411
1179-1411