title: Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant) in Pakistan.
abstract: BACKGROUND
  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).
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Syed Khurram
authors.initials: SK
authors.lastname: Azmat
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Waqas
authors.initials: W
authors.lastname: Hameed
authors.affiliation: FHI 360, Durham, NC, USA.
authors.forename: Anja
authors.initials: A
authors.lastname: Lendvay
authors.affiliation: Health Services Academy, Islamabad, Pakistan.
authors.forename: Babar Tasneem
authors.initials: BT
authors.lastname: Shaikh
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Ghulam
authors.initials: G
authors.lastname: Mustafa
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Muhammad Ahmed
authors.initials: MA
authors.lastname: Siddiqui
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Sajid
authors.initials: S
authors.lastname: Brohi
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Asif
authors.initials: A
authors.lastname: Karim
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Ishaque
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Wajahat
authors.initials: W
authors.lastname: Hussain
authors.affiliation: Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan.
authors.forename: Mohsina
authors.initials: M
authors.lastname: Bilgrami
authors.affiliation: FHI 360, Durham, NC, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Feldblum
keywords: Femplant; Pakistan; acceptability; contraception; efficacy; family planning; implant; safety