A 5-year clinical evaluation of Norplant implants in Senegal.

ABSTRACT

The principal objective of this 5-year clinical study of Norplant implants was to introduce these implants into the family planning program in Senegal and to determine their overall acceptability and safety in Senegalese acceptors. A total of 300 subjects were enrolled into the trial from August 1986 to July 1991. All the women were followed-up for 5 years or until the implants were removed. The pooled cumulative discontinuation rate was 40.8 +/- 2.91 per 100 women resulting in a continuation rate of 59.2 +/- 2.91 per 100 women. Thirteen subjects (4.3%) were lost during the follow-up. Seven pregnancies were reported throughout the 5 years leading to a cumulative pregnancy rate of 3.3 +/- 1.25 per 100 women. Menstrual problems were the reason most often given for early removal during the first 2 years. After year 2, desire for another pregnancy was the main reason for implant removal. The results presented in this study show that the Norplant implant system is a safe, effective, and acceptable method that meets the needs of the Senegalese family planning program.

ABSTRACT

PIP A 5-year prospective, noncomparative clinical evaluation of Norplant implants was conducted to introduce these implants into the family planning program and to determine the acceptability among women users in Senegal from August 1986 to July 1991. Findings showed that the pooled discontinuation rate was 40.8 +or- 2.91 per 100 women, resulting in a continuation rate of 59.2 +or- 2.91 per 100 women. During follow-up, 13 (4.3%) subjects were lost. Throughout the 5 years, 7 pregnancies were reported leading to a cumulative pregnancy rate of 3.3 +or- 1.25 per 100 women. The most common reason for early removal during the first 2 years was menstrual problems, while the main reason for removal in the second year was the desire to have a child. Overall, the Norplant implant system is a safe, effective, and acceptable method that is suitable for the Senegalese family planning program.