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  • Title: The Prentif contraceptive cervical cap: a contemporary study of its clinical safety and effectiveness.
    Author: Koch JP.
    Journal: Contraception; 1982 Feb; 25(2):135-59. PubMed ID: 7075188.
    Abstract:
    Because they seemed to be an overlooked, underutilized, and underdeveloped means of contraception, cervical caps were offered to patients in a private gynecological practice and the first 413 acceptors were sent a detailed questionnaire about their experiences. The 371 who responded provided generous amounts of information helpful in assessing not only cap safety and effectiveness, which are dealt with herein, but also in assessing acceptability which is dealt with in the companion article that follows. With regard to safety considerations, "cervical erosion" was not found to contraindicate cap use and no other significant safety hazards were encountered, although two concerns were suggested for further evaluation. The failure rate was 8.4 per 100 women per year by the life table method. Of 25 failures, 11 were labeled method failures and 14 were labeled human failures by the respondents themselves. The role of cap dislodgement as a cause of method failures is analyzed. It is concluded that caps are as safe and effective as diaphragms and that for many women they are the most suitable form of contraception available. It is reasonable to expect that they will soon be able to be approved for general use. Cervical caps were offered to patients in a private gynecological practice in Massachusetts, and the first 413 acceptors were mailed a questionnaire asking about their experiences. The caps had been fitted between December 1977-September 1979. The only cap used in this study was the Prentif Cavity-Rim Cervical Cap. Delfen Cream was selected for the cap acceptors. 6 guidelines for satisfactory cap fitting are presented along with methods for training patients in the use of the cap. 371 acceptors returned their questionnaires; 8 had never used their caps after they left the office. 363 were included in the study, but all respondents did not answer all questions. With regard to safety considerations, "cervical erosion" was not found to contraindicate cap use. There were no other significant safety hazards. 4 of 253 respondents reported abnormal Pap tests since beginning cap use, but 3 of these women had had abnormal Pap tests shortly before they received their caps. No case of cervical cancer was found in any of the respondents. 12 of 255 respondents reported injuries to the cervix and vagina; 4 gave explanations that were clearly unrelated to cap use. 19% of 249 respondents reported that their menstrual periods had changed significantly since using the cap. The use of cervical caps had little, if any, "net" effect on the frequency of urinary tract infections. There were 25 pregnancies in 3243 months of exposure, yielding a Pearl Index of 9.25 pregnancies/l00 years of exposure. The failure rate was 8.4/100 women per year by the life table method. Of 25 pregnancies, 11 were labeled failures and 14 were labeled human failures by the respondents themselves. Dislodgement contributed importantly to the 11 method failures reported. In sum, the Prentif cap has been found to be as safe and effective as the diaphragm.
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