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  • Title: Experience of Thai women in Bangkok with Norplant-2 implants.
    Author: Chompootaweep S, Kochagarn E, Tang-Usaha J, Theppitaksak B, Dusitsin N.
    Journal: Contraception; 1998 Oct; 58(4):221-5. PubMed ID: 9866003.
    Abstract:
    A prospective study of the Norplant-2 contraceptive subdermal implant system was conducted in Bangkok, Thailand. The objective of the study was to evaluate the efficacy, adverse effects, and overall acceptability of Norplant-2 implants. A total of 140 women were enrolled in a 3-year clinical trial. The mean age was 29 years. Of all the acceptors, 70% had completed primary school. The continuation rates at years 1, 2, and 3 were, respectively, 94%, 89%, and 83%. No accidental pregnancies occurred throughout the 3 years of use in this study. Personal reasons were the leading cause for termination of Norplant-2 implant use. The 3-year cumulative termination rate for personal reasons was 7.2%. These personal reasons were divorce, husband having vasectomy, and moving away from the study area. The other leading cause for termination was medical reasons; acne, headache, and pain at the implant site were the complaints. The termination rate for medical reasons in year 3 of the study was 4.6%. Prolonged menstrual flow was the other main reason for termination. The 3-year cumulative termination rate for menstrual irregularities was 3.8%. In this study, the cumulative termination for planned pregnancy at the end of the year 3 was only 1.6%. The incidence of difficult removals was 8%. Breakage of the rods on removal was encountered in the majority of these cases. The study findings presented suggest that the Norplant-2 implants are highly effective with high continuation rates. The Norplant-2 system could become another choice of long acting reversible contraception for Thai women. Since 1986, Thailand's National Family Planning Program has included the Norplant 6-capsule implant system. The present paper reports the results of a 3-year Phase III clinical trial of the newly developed 2-rod system (Norplant-2). A total of 140 women (mean age, 29 years), in Bangkok, were enrolled and 103 women completed 3 years of method use. The continuation rates at 1, 2, and 3 years were 93.9%, 89.2%, and 82.8%, respectively. There were no accidental pregnancies during the 3-year study period. The 3-year cumulative termination rate was 7.2% for personal reasons (e.g., divorce, husband underwent vasectomy), 4.6% for medical reasons (e.g., acne, headache, pain at the implant site), and 3.8% for menstrual irregularities. A total of 125 acceptors underwent Norplant removal either during or at the end of the study period. The incidence of difficult removals was 8%. In most of these cases, the difficulty involved rod breakage. The average time required for removal was 3.4 minutes. These findings indicate that Norplant-2 is a safe, effective, acceptable contraceptive method appropriate for inclusion in Thailand's family planning program. The potential for fragmentation of the rods during removal requires careful monitoring, however.
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