Contraception
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Clinical Trial
Vaginal bleeding patterns among women using one natural and eight hormonal methods of contraception.
Menstrual diary records were obtained from a total of 5257 women using nine different methods of contraception, one natural and eight hormonal. This paper presents a comparative analysis of their vaginal bleeding patterns. The analytic procedures follow the recommendations of a recent WHO workshop on bleeding pattern analysis, which involve dividing each subject's diary into successive 90-day reference periods, calculating ten indices for each period, and classifying women according to whether they have "clinically important" bleeding disturbances. ⋯ The incidence of amenorrhea rose from just under 10% in their first injection interval to over 40% in their fourth. The methods of analysis recommended by WHO in 1985 still require substantial refinement. Nevertheless, they are more sensitive than those used previously for WHO trials and produce an easily understood, clinically meaningful characterization of bleeding patterns.
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A microcomputer software was developed to analyse menstrual diaries following the reference period method as described in the article "The analysis of vaginal bleeding patterns induced by fertility regulating methods" published in this journal (Contraception, 34:253-260, 1986). The programme allows the analysis of groups of diaries selected according to subjects' characteristics recorded at commencement of the diary. ⋯ The output can be presented graphically as Box-whisker plots. A tutorial is included in the package.