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  • Title: Evaluation of safety, efficacy, and acceptability of NORPLANT implants in Sri Lanka.
    Author: Basnayake S, Thapa S, Balogh SA.
    Journal: Stud Fam Plann; 1988; 19(1):39-47. PubMed ID: 3129828.
    Abstract:
    This paper presents findings based on a one-year pre-introductory clinical investigation concerning safety, efficacy, and acceptability of the new contraceptive NORPLANT implants in Sri Lanka. The study is based on 400 acceptors of the implants at two clinics in Sri Lanka. Acceptors' mean age was 27 years, mean number of children was about two, and average educational attainment was eight years. Nearly half of the acceptors did not want to have another child. Follow-up was conducted at one, three, six, and twelve months. The one-year termination rate due to medical problems was very low, and the one-year life-table pregnancy rate was 0.5. Menstrual pattern disruption was the most frequently reported complaint with the implants. Amenorrhea increased in the first three months of use, and intermenstrual bleeding was common among those menstruating. In spite of these changes and some significant variations between the acceptors in the two study center, the overall degree of satisfaction with the implants was very high. The features most important to the acceptability of the implants were low risk of pregnancy, the long duration of action, and the convenience of use. The results of the study suggest that NORPLANT implants are safe, effective, and highly acceptable to Sri Lankan women. This paper presents findings based on a 1 year pre-introductory clinical investigation concerning safety, efficacy, and acceptability of the new contraceptive Norplant implants in Sri Lanka. The study is based on 400 acceptors of the implants at 2 clinics in Sri Lanka. Acceptors' mean age was 27 years, mean number of children was about 2, and average educational attainment was 8 years. Nearly 1/2 of the acceptors did not want to have another child. Follow-up was conducted at 1,3,6, and 12 months. The 1 year termination rate due to medical problems was very low, and the 1 year life-table pregnancy rate was 0.5. Menstrual pattern disruption was the most frequently reported complaint with the implants. Amenorrhea increased in the 1st 3 months of use, and intermenstrual bleeding was common among those menstruating. In spite of these changes and some significant variations between the acceptors in the 2 study centers, the overall degree of satisfaction with the implants was very high. The features most important to the acceptability of the implants were low risk of pregnancy, the long duration of action, and the convenience of use. The results of the study suggest that Norplant implants are safe, effective, and highly acceptable to Sri Lankan women when administered by health personnel who are well trained in counseling women about the features of the method and in the proper insertion and removal techniques. Despite the overall high level of acceptability, some important variations were found with respect to the sociodemographic characteristics, effectiveness, satisafction, and adverse experiences between the 2 groups of acceptors in the study centers. This variation underscores the importance of conducting the study in more than 1 clinic within a country.
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