Five-year evaluation of safety, efficacy and acceptability of Norplant implants in Nepal.

This paper presents findings based on a five-year, noncomparative study of Norplant contraceptive subdermal implants in Nepal. The study was designed to evaluate the contraceptive safety, efficacy, and overall acceptability of Norplant. Four hundred and seven women enrolled in the clinical trial, which began in 1985, at two study sites, located in Patan and Kathmandu. Follow-up visits were scheduled at 1, 3 and 6 months after Norplant insertion and every six months thereafter until removal or at the end of five years. Although five pregnancies were reported during the study, only two women (one from each center) were diagnosed as becoming pregnant while using Norplant. The pooled gross cumulative life-table pregnancy rate was 0.6 per 100 women at the end of five years. The pooled cumulative continuation rate was 62 per 100 women at the end of five years. The three most frequently reported reasons for discontinuation were menstrual problems, personal reasons, and medical reasons. Of the 125 women who completed a five-year user satisfaction questionnaire, the majority of the women (86%) planned to continue using contraception after study completion. Of these women, almost one half said they planned to use a second Norplant set. The findings suggest that the Norplant system is a safe, effective, and acceptable method of contraception among Nepalese women.

Risk factors for discontinuation of Norplant implant use due to menstrual problems.

The objective of the analysis reported here was to examine risk factors for early discontinuation of Norplant implant use due to perceived menstrual problems. Cox's proportional hazard regression model was used to calculate adjusted hazard ratios that would reflect the relationship of selected subject characteristics to the risk of early discontinuation due to perceived menstrual problems. Approximately 13% of the study population discontinued for perceived menstrual problems. At the end of year 2, the gross cumulative life table discontinuation rate for perceived menstrual problems was 9.4 per 100 women and it rose to 16.4 per 100 women at the end of year 5. Women in this study were significantly more likely to discontinue Norplant implant use due to perceived menstrual problems if they had a higher education level (> 12 years), had used no contraceptives in the month before Norplant implant insertion, or had a relatively long average duration of menstrual flow at admission. identifying potential risk factors such as these may help providers to counsel and prepare women to use the Norplant implant method.

Norplant implants acceptability and user satisfaction among women in two African countries.

An analysis of 350 users of Norplant contraceptive subdermal implants from six centers in two African countries (Ghana and Nigeria) indicates that method acceptability remained high among the women who used the method for five years. Overall, 90.1% of the 155 five-year users in these countries reported having a very favorable experience and 9.9% a favorable experience with Norplant implants. Ease of use was cited by 56.1% and duration of use by 13.6% of the women as the most liked characteristics of the method at study completion after five years. Menstrual disturbance was the least liked aspect, by 41.9% of the women. On average, women who discontinued early from the study had fewer living children and were more likely to desire additional children at method adoption than those who completed five years of use; the differences were statistically significant. Differences in level of education and previous use of contraception were not found to be statistically significant between completers and non-completers. Differences in age were not significant in Nigeria, but were marginally significant in Ghana, with completers being older than non-completers. Of the clients who completed this study, 79.2% indicated a desire to continue with contraception and 43.9% planned to have a second set of implants inserted. These findings have important implications for counseling, method access and service sustainability in African countries.

Complications and risk factors associated with the removal of Norplant implants.

OBJECTIVE: To describe the complications reported at the removal of Norplant implants, and to suggest potential risk factors for these complications. METHODS: Complications at the removal of Norplant implants from 3416 users from 11 countries who participated in preintroductory clinical trials of the method were tabulated. A logistic regression model was used to identify the significant risk factors associated with removal complications. RESULTS: Complications were reported in 4.5% of removals; most often, they were related to broken or deeply placed implants. The most important risk factors were complications at insertion and having an infection at the implant site (at or before removal). CONCLUSION: Proper insertion technique under aseptic conditions is very important in predicting whether Norplant implant removal will be difficult. Although relatively infrequent even now, more vigilant training and the evaluation of some of the newer removal techniques could further reduce the incidence of difficult removals.

Norplant contraceptive acceptability among women in five Asian countries.

An analysis of 1,882 Asian acceptors of Norplant implants indicates that method acceptability remained high among the 882 women who used the method for five years. Women who discontinued early from the study were, on average, younger than those who completed five years of use. Also, they had fewer live births and were more likely to desire additional children. Overall, about 70% of the women in these countries found the Norplant implant method to be very favorable. The majority (> 40%) of the women found the ease and duration of use of the method to be most attractive, while menstrual disturbances were the least-liked aspect of the method. Although it was apparent that there are still some potential obstacles to Norplant implant acceptance, most noticeably concerns about menstrual irregularities, interest in continuing the method after five years of use is high. Further research of issues related to Norplant implant acceptability may improve continuation rates and overall client satisfaction.

PIP: Norplant method acceptability was assessed in women who completed 5 years of use, and their sociodemographic profile was compared with that of those who discontinued early. The population consisted of 1882 women, 882 of whom completed the study. The subjects were from 3 sites in Bangladesh, 2 each in the Philippines, Nepal and Sri Lanka, and 1 in Singapore. Women in the group who discontinued early (noncompleters) were significantly younger (p 0.05) than women who completed 5 years of use (completers): the mean difference in age ranged from 1.4 years in the Philippines to 4.5 years in Singapore. For all subjects the mean educational level varied from 2.1 years in Nepal to 10.0 years in the Philippines. The mean number of live births varied significantly, ranging from 2.1 in Singapore and Sri Lanka to 3.4 in Bangladesh. In all countries, noncompleters had a significantly lower mean number of live births and were more likely to desire additional children. A user satisfaction questionnaire was administered at 5 years postinsertion to completers. In Sri Lanka, almost 90% of the completers indicated very favorable experience, as did more than 70% of the completers in Bangladesh and Singapore. The most liked feature of the implants for completers in Bangladesh, Nepal, and Sri Lanka was its duration for 5 years. Low risk of pregnancy was the most liked feature of the implants in fewer than 25% of the subjects in each country, and as few as 1.6% in Nepal. The least liked feature of the implants for both completers and noncompleters at 6 months was menstrual disturbance. Most completers in all 5 countries (ranging from 87.4% in Sri Lanka to 99.4% in the Philippines) would recommend Norplant implants to a friend. 73.9% of women in Sri Lanka and 91.4% in Singapore planned to continue using contraception after Norplant removal; and Norplant was the most popular choice in Sri Lanka (41.5%), Nepal (49.1%), and Singapore (69.8%).

A five-year clinical evaluation of Norplant contraceptive subdermal implants in Bangladeshi acceptors.

A non-comparative study of the Norplant contraceptive subdermal implant system was conducted in Dhaka, Bangladesh. The study was designed to evaluate the contraceptive efficacy, safety and overall acceptability of Norplant implants. Six hundred women were enrolled in the clinical trial, which began in 1985 at three study sites. Follow-up visits were scheduled at 1, 3, and 6 months after Norplant implant insertion, and every six months thereafter until removal or at the end of five years. There were no post-insertion pregnancies during Norplant implant use in this study. After five years of Norplant implant use, there was no clinically significant change in body weight, systolic or diastolic blood pressure. Less than 3% of the women ever reported having any significant medical problems such as migraine, respiratory or cardiac problems during the study. The gross cumulative continuation rate was 41.2 per 100 women at the end of five years. The two most frequently reported reasons for discontinuation during the study were menstrual problems and desired pregnancy. Of the women who completed the five-year user satisfaction questionnaire, the majority of the women (86.3%) planned to continue using contraception after study completion. Of these women, approximately one-third said they planned to use another Norplant set. The findings presented suggest that the Norplant system is a highly effective, safe and acceptable method among Bangladeshi women.

PIP: From February 1985 to February 1986, researchers enrolled 600 18-40 year old women at the Dhaka Medical College and Hospital, the Institute of Postgraduate Medicine and Research, and the Mohammadpur Fertility Services and Training Centre in a 5-year clinical trial to evaluate the contraceptive efficacy, safety, and acceptability of Norplant subdermal implants in Bangladesh. They scheduled the women to return for follow-up visits 1, 3, and 6 months after insertion and every 6 months thereafter until removal or at the end of 5 years. No pregnancies after insertion occurred during the study. The gross cumulative continuation rate was 93.9% at 1 year and 72.3% at 2 years. The 5-year cumulative continuation rate was 41.2% which was much lower than that in other Asian countries (e.g., 52.3% in Sri Lanka and 78.2% in Indonesia). The 5-year cumulative discontinuation rate for menstrual problems was 30.7% which was higher than that of other studies. It may have been higher because Bangladeshi women do not tolerate well and accept changes in bleeding patterns, especially since menstrual bleeding prevents them from prayer and taking part in sexual activity. 45.3% of all women requesting early Norplant removal complained of menstrual problems, especially prolonged heavy bleeding (75% of women requesting removal for menstrual problems). Most menstrual problem removals took place during the 2nd year and fell thereafter. Desired pregnancy was the second most common reason for removal (18.6%). The gross discontinuation rate for nonmenstrual side effects was just 2.2%, the main side effect being headaches. 97.5% of women who completed the 5-year study considered their experience with Norplant favorable. The leading reason for a favorable rating for Norplant was its duration of use (64.5%). Menstrual changes comprised the least favorable component of Norplant among women who completed the study (63.3%). 33% of women still wanting to use contraception after 5 years of Norplant use said they would use Norplant again.