Experience of Thai women in Bangkok with Norplant-2 implants.

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.

PIP: 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.

Effectiveness of Norplant implants among Thai women in Bangkok.

The purpose of the study was to evaluate the efficacy, acceptability, side effects and continuation rates of the implant system in Thai women. A five-year clinical study of 308 women receiving Norplant-6 implants in Bangkok was conducted. Acceptors' mean age was 29 years, and mean number of children was about two. More than half of the users (63%) finished primary school. The cumulative continuation rates for Norplant implants at first, second, third, fourth and fifth years were, respectively, 98%, 91%, 83%, 78% and 71%. Eight out of a total of eleven pregnancies occurred in the fourth and fifth year of use. The cumulative pregnancy rate was 1.1% for the third year, 2.0% for the fourth year and 4.2% for the fifth year. Desire for future pregnancy was the leading cause for termination of Norplant implants use. The five-year cumulative termination rate for planned pregnancy was 9.2%. Disruption of menstrual rhythm, particularly increased bleeding, was the other main reason for termination; however, the prevalence of menstrual irregularities appeared to diminish with time. The cumulative termination rate for menstrual irregularities in the fifth year of the study was 4.4%. The complaints of "other medical reasons" for removal of Norplant implants were acne, severe headache, and chloasma. The five-year cumulative termination rate for other personal reasons was 7.9%. These personal reasons were husband having vasectomy, husband objection and divorce. It can be seen from this five-year study that Norplant implants are well accepted by Thai women. However, the efficacy in preventing pregnancy was not acceptable during the fourth and fifth year of use in this study, which was different from results of other international studies.

PIP: Between June 1986 and December 1988, staff at a family planning clinic in greater Bangkok, Thailand, recruited 308 healthy women aged 18-45 for a clinical trial designed to evaluate the efficacy, acceptability, side effects, and continuation rates of the contraceptive implant system Norplant. Their average parity was 1.9 live births. The cumulative first-, second-, third-, fourth-, and fifth-year continuation rates stood at 97.6%, 90.7%, 82.9%, 77.9%, and 71%, respectively. During the first two years, no Norplant acceptor became pregnant. In the third year, however, the cumulative accidental pregnancy rate was 1.1% and increased to 2% in the fourth year and 4.2% in the fifth year. All accidental pregnancies were intrauterine. The major reason for Norplant removal was desire for pregnancy (5-year cumulative termination rate = 9.2%) followed by changes in menstruation patterns, particularly increased menstrual bleeding (4.4%). The prevalence of menstruation disorders decreased with time, however. For example, 64.8% of all users experienced an irregular menstrual cycle during the first 1-3 months of Norplant use. By 22-24 months of use, it had fallen to 54.9%, and to 39.5% by 58-60 months of use. The five-year cumulative termination rate for other personal reasons was 7.9%. These reasons included husband undergoing vasectomy, husband's objection to Norplant, and divorce. The relatively high continuation rates at the first and fifth year of use suggest that Thai women accepted Norplant well. The higher accidental pregnancy rates at four and five years of use than those of other international studies are troublesome, however.