title: Performance of Sino-implant (II) in routine service delivery in Madagascar.
abstract: BACKGROUND
  Sino-implant (II) is a low-cost subdermal contraceptive implant containing levonorgestrel that is currently labeled for 4 years of use. Widely used in China and Indonesia, it has been little studied elsewhere. We conducted a prospective study of Sino-implant (II) use by women in Madagascar.
  
  
  METHODS
  We enrolled a total of 621 women 18 or older who had Sino-implant (II) inserted on day of enrollment, some in fixed clinical sites, and some at outreach sites. Half of the women were scheduled for follow-up visits at 3 months and at 12 months postinsertion (active follow-up cohort); the other half were advised to return if they desired care for any problem, thought they were pregnant or wanted the implants removed (passive surveillance cohort).
  
  
  RESULTS
  No insertion complications were reported. A total of 384 women returned for an earlier visit, and 351 returned for a later visit, for a total of 419 woman-years of observation. No postinsertion pregnancies or serious adverse events were observed. Twenty-eight implant removals were reported by 12 months, a cumulative removal probability of 7.3 per 100 women. Acceptability of the implants was very high, as was satisfaction with clinic services.
  
  
  CONCLUSIONS
  This is the first report on the performance of Sino-implant (II) from outside China and Indonesia and among the first in the English-language literature. These initial data from Madagascar indicate a favorable level of safety, effectiveness and acceptability during the first year of use.
authors.affiliation: FHI 360, Clinical Sciences Unit, P.O. Box 13950, Research Triangle Park, NC 27709, USA. pfeldblum@fhi360.org
authors.forename: P J
authors.initials: PJ
authors.lastname: Feldblum
authors.forename: O
authors.initials: O
authors.lastname: Hanitriniaina
authors.forename: A
authors.initials: A
authors.lastname: Lendvay
authors.forename: K
authors.initials: K
authors.lastname: Hopkins
authors.forename: A
authors.initials: A
authors.lastname: Wheeless
authors.forename: M
authors.initials: M
authors.lastname: Chen
authors.forename: M J
authors.initials: MJ
authors.lastname: Steiner
mesh_terms: D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D003268:Contraception Behavior / Q000208:ethnology; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects; D020878:Device Removal; D004343:Drug Implants; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects; D008137:Longitudinal Studies; D008270:Madagascar; D010342:Patient Acceptance of Health Care / Q000208:ethnology; D017060:Patient Satisfaction / Q000208:ethnology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D004343:Drug Implants; D016912:Levonorgestrel