Document Type
Article
Department
Community Health Sciences
Abstract
Background: Sino-implant (II) is a two-rod subcutaneous contraceptive implant used up to 4 years, containing 150 mg of levonorgestrel. We conducted two observational studies of Sino-implant (II) to evaluate its performance in routine service delivery settings.
Methods: We enrolled 1326 women age 18-44 who had Sino-implant (II) inserted at clinics in Pakistan and Kenya. Women were followed-up using either an active or passive follow-up scheme in each study. Study outcomes were: one-year cumulative pregnancy and discontinuation rates; rates of insertion and removal complications; adverse event and side effect rates; reasons for discontinuation; and implant acceptability and satisfaction with clinic services.
Results: A total of 754 women returned for at least one follow-up visit. The overall Pearl pregnancy rate was 0.4 per 100 woman-years [95% confidence interval (CI) 0.1, 0.9] resulting from 1 confirmed post-insertion pregnancy in Kenya and 4 in Pakistan. Country-specific Pearl rates were 0.2 (95% CI 0.0, 0.9) in Kenya and 0.6 (95% CI 0.2, 1.6) in Pakistan. The total cumulative 12-month probability of removal was 7.6% (95% CI 6.1, 9.1), with country-specific removal probabilities of 3.7% in Kenya (95% CI 2.1, 5.3) and 10.8% in Pakistan (95% CI 8.5, 13.2). Four serious adverse events occurred in Kenya and none occurred in Pakistan; one SAE (an ectopic pregnancy) was possibly related to Sino-implant (II). Most women in both countries said they would recommend the implant to others.
Conclusion: The results from these studies reveal high effectiveness and favorable safety and acceptability during the first year of use of Sino-implant.
Implication: The favorable Sino-implant (II) findings from Kenya and Pakistan provide further evidence from disparate regions that Sino-implant (II) is safe, effective and acceptable during routine service delivery.
Publication (Name of Journal)
Contraception
Recommended Citation
Lendvay, A.,
Otieno-Masaba, R.,
Azmat, S. K.,
Wheeless, A.,
Hameed, W.,
Shaikh, B. T.,
Kuria, S.,
Steiner, M. J.,
Chen, M.,
Feldblum, P. J.
(2014). Effectiveness, safety and acceptability of Sino-implant (II) during the first year of use: Results from Kenya and Pakistan. Contraception, 89(3), 197-203.
Available at:
https://ecommons.aku.edu/pakistan_fhs_mc_chs_chs/903
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Included in
Maternal and Child Health Commons, Obstetrics and Gynecology Commons, Women's Health Commons