- Email: [email protected]
The cervical cap: A retrospective study of an alternative contraceptive technique
Andreyko et al.
March 1, 1984 Am. J. Obstet. Gynecol.
bidity were related only to lower gestational age, not to the duration of premature rupture of the membranes. At this Unit, we have found that neonatal mortality and long-term major morbidity reach a minimum at 32 weeks' gestation, 1 with no further decrease in this figure beyond 32 weeks. Therefore, the induction of labor in patients who present with premature rupture of the membranes at or beyond 34 weeks' gestation is a logical approach in order to minimize maternal infectious morbidity, since neonatal mortality and morbidity have already reached minimum levels at that stage of gestation. However, neither maternal nor neonatal infectious morbidity increases beyond 24 hours of premature rupture of the membranes, and neonatal mortality and morbidity are related to lower gestational age. Therefore, at earlier stages of gestation, conservative management in a tertiary care unit, with careful surveillance for infection and fetal hypoxia, is a rational approach to the problem of premature rupture of the membranes, in the attempt to achieve further in utero fetal maturation.
REFERENCES 1. MiIligan,J. E., Shennan, A. T., and Hoskins, E. M.: Perinatal intensive care: Where and how to draw the line, AM. J. OBSTET. GYNECOL. In press. 2. Philip, A. G. S., and Hewitt, J. R: Early diagnosis of neonatal sepsis, Pediatrics 65: 1036, 1980. 3. Garite, T. J., Freeman, R. K., Linzey, E. M., et al.: The use of amniocentesis in patients with premature rupture of membranes, Obstet. Gynecol. 54:226, 1979. 4. Mead, P. B., and Clapp, J. E.: The use of betamethasone and timed delivery in management of premature rupture of the membranes in the preterm pregnancy, J. Reprod. Med. 19:3, 1977. 5. Berkowitz, R L., Hoder, E. L., Freeman, R. M., et al.: Results of a management protocol for premature rupture of the membranes, Obstet. Gynecol. 60:271, 1982. 6. Graham, R L., Gilstrap, L. C., Hauth, J. C., et al.: Conservative management of patients with premature rupture of fetal membranes, Obstet. Gynecol. 59:607, 1982. 7. Varner, M. W., and Galask, R P.: Conservative management of premature rupture of the membranes, AM. J. OBSTET. GYNECOL. 140:39, 1981. 8. Gibbs, R S., and Blanco, J. D.: Premature rupture of the membranes, Obstet. Gynecol. 60:671, 1982. 9. Mead, P. B.: Management of the patient with premature rupture of the membranes, Clin. Perinatol. 7:243, 1980.
The cervical cap: A retrospective study of an alternative contraceptive technique Joann M. Johnson, M.D.
Winnipeg, Manitoba, Canada A follow-up study on 130 women fitted with a cervical cap over a 12-month period drew a response rate of 43% (56 respondents). The group was young, well educated, and highly motivated. The failure rate was 16.9 per 100 women years (Pearl method), with inconsistent use and dislodgement being of major importance. The continuation rate was 75% (minimum 3 months of use), and 84% expressed satisfaction with the method. No significant side effects or risks to health were encountered. The conclusion is that there is a significant demand for alternative contraceptive methods among a select group of women. However, in the present state of knowledge, use of the cap should probably not be encouraged as a primary means of contraception, but should be reserved for those women with multiple contraceptive problems or for highly motivated women who seek out this means, understand its limitations, and can accept the relative uncertainty of its effectiveness. (AM. J. OBSTET. GVNECOl. 148:604, 1984.)
In recent years, the lay press and women's health groups have given much attention to the use of the
From the Department of Obstetrics, Gymcology and Reproductive Sciences, University of Manitoba. Presented at the Thirty-ninth Annual Meeting of The Society ofObstetricians and Gynaecologists of Canada, Vancouver, British Columbia, Canada, june 14-18,1983. Reprint requests: Joann M. Johnson, M.D., Department of Obstetrics, Gynecology and Reproductive Sciences, University of Manitoba, WinniPeg, Manitoba, Canada.
604
cervical cap as a contraceptive method. The cap has, however, continued to find only limited acceptance among medical professionals in this country. The reason for this reluctance is mainly a lack of data on its safety, efficacy, and clinical acceptability. To attempt to clarify this, a follow-up study was conducted by means of a questionnaire survey of 130 women fitted with a cervical cap over a 12-rnonth period. The study was designed to answer three questions. What is the effectiveness of the cap in a group of
Cervical cap 605
Volume 148 Number 5
Table II. Previous contraceptive experience
Table I. Characteristics of the group studied Characteristic
% of 56 respondents Method
Methods ever used by the 56 respondents (%)
Age* (yr) <20 20-24 25-29 30-34 ~35
Educationt (highest level attained) High school University Vocational training Employment (some responded to more than one category) Full-time Part-time Unemployed Student Homemaker Relationship status Married Single Common-law
7 43 34 16 0
Foam and condom Oral contraception Intrauterine contraceptive device Rhythm and natural Diaphragm Nonspecific
98 65 29 27 21 5
II 79 10
54 10
3 38 7 25 55 20
*A
total of 77% were in their twenties. t A total of 100% had completed high school.
women practicing contraception? What side effects are noted with such use? What is the overall applicability of the method? It is not surprising that most clinicians are unfamiliar with the contemporary use of the cervical cap. First described by Friedrich Wilde, a German gynecologist, in 1838, the cap was once the most widely used barrier method of contraception in Western Europe and England. '2 Although it never achieved the same popularity in North America, where most clinicians preferred to prescribe the diaphragm, there was a significant incidence of use of the cap between 1900 and 1940. However, with the advent of oral contraceptives, intrauterine devices, and improved techniques of surgical sterilization, its use declined to near extinction, until recently. Now, the increasing apprehension on the part of both medical and lay populations concerning the known and potential risks associated with these newer methods has resulted in renewed interest in the old barrier methods, including the cap. The present study was undertaken because there are very few data on this device, the design of which has changed little over the years.
Material and methods Between July 1, 1981, and June 30, 1983, 130 women were fitted with a cervical cap at the Women's Health Clinic in Winnipeg. These included those who attended the clinic specifically to request the cap, and those who came seeking contraceptive advice, were offered the cap, and agreed to its use.
Type of cap and spermicide used. The only cap used in this study was the Prentif cavity rim cervical cap (manufactured by Lamberts, Ltd., London, England), which is available in four sizes (22, 25, 28, and 31 mm in diameter). The Prentif cap is a thimble-shaped cup made of rubber, with a firm rim and flexible dome designed to retain spermicidal cream or jelly. The rim adheres to the cervix by suction at the vaginal fornices, and the dome covers the tip of the cervix. The Prentif cap was selected because it seemed to be the best available according to studies on fit, stability, and retention of spermicide. 2 All the women were advised to use spermicidal cream or jelly with the cap. No specific brand was recommended. Fitting techniques. Each patient was fitted with a cap and instructed in its use by a physician. She was allowed to practice self-insertion and removal, checked by the physician, until it was considered that she had mastered the technique. Additional counseling was provided as necessary, and all patients received a standard instruction sheet and were advised to return for follow-up at 3 months, or earlier if any difficulties were encountered. In addition, it was recommended that a back-up contraceptive method be used for the first 3 months, and that the cap should not be used during the menstrual period. The questionnaire. In September, 1982, these 130 women were mailed a questionnaire that contained 35 questions designed to determine pregnancy rates and causes, major and minor risks, annoyances and satisfactions. The date on which the cap was first prescribed and the date on which the questionnaire was received were taken as the beginning and ending dates for participation in the study. Data on safety, effectiveness, and acceptability obtained from the questionnaire are the basis of this report.
Results Of the 130 women to whom the questionnaire was sent, 56 responded (43%). In some instances, the reply to the questionnaire was incomplete. Characteristics of the group studied. Most of the patients were young, well educated, single, employed, and practicing intercourse with a regular partner
606 Johnson
March I, 1984 Am. J. Obstet. Gynecol.
Table III. Reasons for selecting the cap Order of importance
Percentage
Does not affect a woman's natural hormones Not usually felt by user or partner Does not interrupt foreplay or intercourse More natural method of birth control Teaches a woman more about her own body Does not require daily involvement Inexpensive
93 91 86
84 82 77 56
(Table I), Most had previously used one or more contraceptive methods (Table II). Seventy-seven percent of the women reported hear·ing about the cap through nonmedical sources of information, and most of them attended the clinic specifically to request it. Thirty percent of the group specifically expressed anti -oral contraceptive sentiments, and the nonhormonal and noninvasive nature of the cap ranked as the most important feature in influencing their selection of the method (Table III). Twenty-eight percent of the group had previously experienced one or more pregnancies, 46% of which had been terminated electively. Effectiveness. The incidence of pregnancy was calculated according to the Pearl pregnancy index, which is defined as: No. of pregnancies per 100 woman years of use = No. of unplanned pregnancies ------'---~-=---.- X 1,200 No. of woman months of observations The n umber of woman months of observation is defined as the sum of the months each woman used the contraceptive method until becoming pregnant or discontinuing use. The Pearl index provides a single measure of use effectiveness as a contraceptive method, and is expressed as the number of pregnancies to be expected in 100 woman years of use. There was a total of five unplanned pregnancies in 355 woman months of exposure, which yielded a Pearl index of 16.9 pregnancies per 100 woman years of exposure. V ser versus method failure. The major problem in evaluating the effectiveness of a barrier method is that failure rates depend so greatly on how reliably and carefully the method is used. Thus, it is useful to estimate how much of the observed failure rate is user rather than method failure. Three of the five women who became pregnant stated that they had failed to use the device consistently. This "user failure" calculated by the Pearl index was 10.4 pregnancies per 100 woman years of use. Two of these women were multiparous, and one had previously had two therapeutic abortions. Of the two women whose pregnancies could be attributed to method failure, one reported finding the cap dislodged, and no cause was identified in the other.
The method failure rate calculated by the Pearl index was 6.5 pregnancies per 100 woman years of use. Acceptability. The majority (84%) of women in this study expressed satisfaction with the cap. Most found it to be more convenient to use than other barrier methods, although 70% did initially experience mechanical difficulties (difficulty in locating the cervix, difficulty with insertion and/or removal, and discomfort with self-examination ). Seventy-five percent stated that their confidence in the method was affected by uncertainties in regard to its safety and effectiveness, and by fear of dislodgement. Twenty-three percent of the 39 respondents who checked consistently found the cap dislodged on one or more occasions. The 14 respondents who stopped using the cap gave as reasons (in decreasing order of importance) "too much trouble," unplanned pregnancy, and discomfort to self or partner. Odor was not a significant problem. In spite of these problems, the continuation rate was 75% at the time of the study. The majority stated that the method had no detrimental effect on sexual activity; and of those who noted an improvement, many stated that a sense of physical and psychologic well-being was responsible for this. They expressed relief from concerns in regard to oral contraceptives and their possible adverse side effects, and found it reassuring to know that they were having "natural" menstrual cycles. Safety. No significant risks to life or health were identified in this study. No local trauma to the cervix or vagina was reported. Of 35 women with previously documented vaginal infections (vaginitis, cervicitis), only seven experienced recurrence of infection. Among the other 21 women, three reported the development of an infection after using the cap. There were no cases of pelvic inflammatory disease and little, if any, net effect on the frequency of urinary tract infections. There were no disturbances in menstrual cycles.
Comment A select group of women who appeared to be highly motivated toward barrier contraception was studied. Their previous experience with other barrier methods, in particular the diaphragm, was high when compared to that reported in other studies,6 and their concern and awareness of the known and potential risks in regard to oral contraceptives and intrauterine devices were significant. The failure rate in this study was high compared to that in other reported studies. Failure rates vary considerably among different studies. The earliest studies, by Konikow (1921) and Yaros (1927), reported failure rates of 4.5% and 3.5%, respectively. However, since they calculated only percentage failure rates and did not consider the length of time of exposure, they are not comparable to other studies. 2 This is also true of a
Volume 148 Number 5
study by Zohdiates and associates,4 who, in a survey of 60 women, found eight unplanned pregnancies, but did not report woman months of use. The well-known study by Tietze and associates/ in 1953, with use of the Pearl index, reported failure of 7.6 per 100 woman years of use, and more recently, Koch and associates/ in Boston, in 1982, reported a failure rate by the Pearl index of 9.25 per 100 woman years of use. In a smaller study by Denniston,5 in 1980, a failure rate of eight per 100 women per 6 months was found, which could be extrapolated to 16 per 100 years. This is the only study in which the failure rate approximated that in the present study. Many factors contribute to these wide ranges of failure rates. The sample size, duration of study period, criteria for selection of suitable candidates, fitting and training techniques, protocols for use, and type of cap and spermicide used all vary among different providers of the cap. Koch2 reports that, since completion of his study, he rejects more than 50% of applicants for the cap because they fail to meet his stringent criteria. On the other hand, other providers of the cap give a cap to every applicant. This will obviously lead to poor fitting and higher rates of pregnancy and dissatisfaction. Equally variable failure rates are reported for the diaphragm, with a range from 1.9% to 19.6%.2 Since the present study was neither randomized nor comparative, it cannot be compared accurately with studies on the diaphragm. The two main factors identified in this study as contributing to the high failure rate were inconsistent use and dislodgement. Inconsistent use resulted in more than three quarters of the pregnancies and emphasizes the importance of screening for unreliable users. The previous contraceptive history of the "user" failure group suggests both high rates of fertility and previously unsuccessful contraceptive practices. Only one pregnancy was attributed to dislodgement; however, a significant number of users did report finding the cap dislodged on one or more occasions. That this likely contributes importantly to method failure has been reported in other studies. 4 Another im portant consideration in regard to method failure concerns the type of spermicide used. Koch 2 has suggested that there may be a higher failure rate associated with the use of creams ven~us jellies, because of the lower water solubility of the creams. As cervical secretions accumulate, they form a layer over the oilbased cream, thereby providing a safe passage for sperm which circumvent the rim of the cap. The more water-soluble jellies dissolve in the cervical secretions, thereby rendering them spermicidal. It may be advisable, therefore, to recommend jelly preparations over creams. The acceptability of the method was high in this
Cervical cap
607
study, thereby reflecting a high tolerance among this group for the various annoyances and inconveniences the method imposes. There was a high rate of satisfaction and a high continuation rate. Most other authors have also reported high acceptability, including Koch, who reported that 91 % of 268 respondents were satisfied with the method. 3 Only Denniston5 has reported high rates of dissatisfaction, with the main causes being fear of dislodgement and discomfort to self or partner. In Koch's3 study, odor was the leading cause of discontinuation of use. This contrasts to the present study in which mechanical difficulties were identified as the major feature disliked about the cap. The most liked feature was the nonhormonal aspect and, also, the convenience of the method compared to other barrier methods. Of major concern is the length of time the cap can safely and effectively remain in place. Recommendations vary from 8 hours to the entire length of the intermenstruum. The effect of prolonged use of an occlusive device on the cervix is not well known, so that, generally, shorter insertion spans have been recommended. The manufacturer of the Prentif cap suggests that the cap be left in no more than 24 hours and be used in a manner similar to that of a diaphragm. In this study, it was recommended that the cap be left in place from a minimum of 8 hours to a maximum of 3 days. The use of a spermicidal agent is also controversial. It is not known whether the major protective effect of the cap is mechanical and chemical or primarily mechanical. In a study by Lehfeldt and associates/ the spermicidal activity of the cap's contents was tested after a period of 7 and 14 days. They found no detectable activity for jellies and minimal activity for creams. Since the women inserted their caps after menstruation, there would be no detectable activity at the time of ovulation-hence, the mechanical barrier attributed to the cap's effectiveness. The most common vaginal spermicide, nonoxynol-9, has been shown in rats and rabbits to be absorbed rapidly through the vaginal mucosa and to be excreted intact within 2 to 4 days.8 No data are available on what happens in humans under actual conditions, but, presumably, there is little local activity once absorption has occurred. Most providers of the cap recommend the use of spermicide, but this likely increases the cap's effectiveness only for this initial period. Spermicides were generally considered to be safe until a recent study by Jick and associates9 indicated that they may increase the incidence of certain birth defects. This requires further study. As can be seen, many questions in regard to the safety of the cap remain. However, the cap appears to pose no significant risk to life or health when used for the recommended spans of insertion. More research is needed in regard to the effects of prolonged use. It appears that the Prentif cap offers no significant
Johnson
advantage over the diaphragm, other than its small size. Both require professional fitting, with the cap requiring an average of 30 minutes for full explanation and fitting. Many proponents claim that a major advantage is the fact that it can be left on the cervix for longer periods of time than can the diaphragm. However, this is not recommended at present. It is encouraging that three major studies on the cap are now underway in the United States. The largest of these three is a comparative study between two types of caps and the standard diaphragm. The other two studies are devoted to designing an improved cervical cap. These studies will be invaluable additions to our current state of knowledge. With the renewed emphasis on safe, simple barrier methods, an improved cervical cap would be a welcome, versatile addition to the limited selection of vaginal contraceptives presently available.
REFERENCES 1. Tietze, c., Lehfeldt, H., and Libeman, H. C.: The effectiveness of the cervical cap as a contraceptive method, AM. J OBSTET. CYNECOL. 66:904, 1953. 2. Koch, J: The Prentif contraceptive cervical cap: A contemporary study of its clinical safety and effectiveness, Contraception 25: 135, 1982. 3. Koch, J: The Prentif contraceptive cervical cap: Ac-
March I, 1984 Am. J. Obstet. Gynecol.
4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
ceptability aspects and their implication for future cap design, Contraception 25:161, 1982. Zohdiates, K. P., Feinbloom, R. I., and Sagov, S. E.: Contraceptive use of cervical caps, New Engl. J Med. 304:915,1981. Denniston, C.: High rates of pregnancy and dissatisfaction mark first cervical cap trial, Fam. Plann. Perspect. 13:48, 1981. Tyner, L., and Bradshaw, L.: Barrier methods. Clin. Obstet. Cynecol. 6:79, 1979. Lehfeldt, H., Sobrero, A. J, and Inglis, W.: Spermicidal effectiveness of chemical contraceptives used with the firm cervical cap, AM. J. OBSTET. CYNECOL. 82:446, 1961. Chapvil, M., Eskelson, C. D., Stiffel, V., et al.: Studies on nonoxynol-9. II. Intravaginal absorption, distribution, metabolism and excretion, Contraception 22:325, 1980. Jick, H., Walker, A. M., Rothman, K. J, et al.: Vaginal spermicides and congenital disorders, JAMA 245:1329, 1981. Fairbanks, B., and Scharfman, B.: The cervical cap. Past and current experience, Women Health, 5:61, 1980. Smith, C.: The use of the cervical cap at the University of California at Berkeley, Am. Coli. Health Assoc. 29:93, 1980. Crafenberg, E., Dickenson, R. L.: Contraception control by plastic cervical cap, West J Surg 52:335, 1944. McBride, C., and Arthur, C.: Customized cervical cap, J. Nurse Midwifery, 25:33,1980. Shelton, A., and Taylor, R.: Pearl pregnancy index reexamined-Stili useful for trials of contraceptives, AM. J OBSTET. CYNECOL. 135:592, 1981. Tatum, H., and Connel-Tatum, E.: Barrier contraception: A comprehensive overview, Fertil. Steril. 36:1,1981.
Non-Hodgkin's lymphoma in Bartholin's gland: Case report and review of literature Leo Plouffe, Jr., M.D., Togas Tulandi, M.D., Arthur Rosenberg, M.D., and Alex Ferenczy, M.D. Montreal, Quebec, Canada Described in this report is a systemic lymphoma which had selectively involved the Bartholin gland. The true prevalence of this phenomenon is not known, but greater attention to these areas of the genital tract may uncover additional cases and provide better insight into the natural history of lymphomas that involve the lower female genital tract. (AM. J. OesTET. GVNECOL. 148:608, 1984.)
Involvement of the vulva and vagina by malignant lymphoma has been described frequently,I, 2 but From the Departments of Obstetrics and Gynecology, Medicine, and Pathology, The Sir Mortimer B. Davis-jewish General Hospital, and Faculty of Medicine, McGill University. Presented at the Thirty-ninth Annual Meeting of The Society of Obstetricians and Gynaecologists of Canada, Vancouver, British Columbia, Canada, june 14-18,1983. Reprint requests: Dr. Alex Ferenczy, Department of Pathology, Sir Mortimer B. Davis-Jewish General Hospital, 3755 Cote SteCatherine Road, Montreal, Quebec, Canada H3T 1E2.
608
non-Hodgkin's lymphoma that involved Bartholin's glands has not been reported previously. We present here the first such case, with a review of the literature.
Case report In December, 1980, a non-Hodgkin's lymphoma was excised from the right breast of a 54-year-old Jewish woman. Computerized tomography showed bilateral para-aortic infrarenal lymphadenopathy. The patient responded well to high-dose doxorubicin, vincristine,
March 1, 1984 Am. J. Obstet. Gynecol.
bidity were related only to lower gestational age, not to the duration of premature rupture of the membranes. At this Unit, we have found that neonatal mortality and long-term major morbidity reach a minimum at 32 weeks' gestation, 1 with no further decrease in this figure beyond 32 weeks. Therefore, the induction of labor in patients who present with premature rupture of the membranes at or beyond 34 weeks' gestation is a logical approach in order to minimize maternal infectious morbidity, since neonatal mortality and morbidity have already reached minimum levels at that stage of gestation. However, neither maternal nor neonatal infectious morbidity increases beyond 24 hours of premature rupture of the membranes, and neonatal mortality and morbidity are related to lower gestational age. Therefore, at earlier stages of gestation, conservative management in a tertiary care unit, with careful surveillance for infection and fetal hypoxia, is a rational approach to the problem of premature rupture of the membranes, in the attempt to achieve further in utero fetal maturation.
REFERENCES 1. MiIligan,J. E., Shennan, A. T., and Hoskins, E. M.: Perinatal intensive care: Where and how to draw the line, AM. J. OBSTET. GYNECOL. In press. 2. Philip, A. G. S., and Hewitt, J. R: Early diagnosis of neonatal sepsis, Pediatrics 65: 1036, 1980. 3. Garite, T. J., Freeman, R. K., Linzey, E. M., et al.: The use of amniocentesis in patients with premature rupture of membranes, Obstet. Gynecol. 54:226, 1979. 4. Mead, P. B., and Clapp, J. E.: The use of betamethasone and timed delivery in management of premature rupture of the membranes in the preterm pregnancy, J. Reprod. Med. 19:3, 1977. 5. Berkowitz, R L., Hoder, E. L., Freeman, R. M., et al.: Results of a management protocol for premature rupture of the membranes, Obstet. Gynecol. 60:271, 1982. 6. Graham, R L., Gilstrap, L. C., Hauth, J. C., et al.: Conservative management of patients with premature rupture of fetal membranes, Obstet. Gynecol. 59:607, 1982. 7. Varner, M. W., and Galask, R P.: Conservative management of premature rupture of the membranes, AM. J. OBSTET. GYNECOL. 140:39, 1981. 8. Gibbs, R S., and Blanco, J. D.: Premature rupture of the membranes, Obstet. Gynecol. 60:671, 1982. 9. Mead, P. B.: Management of the patient with premature rupture of the membranes, Clin. Perinatol. 7:243, 1980.
The cervical cap: A retrospective study of an alternative contraceptive technique Joann M. Johnson, M.D.
Winnipeg, Manitoba, Canada A follow-up study on 130 women fitted with a cervical cap over a 12-month period drew a response rate of 43% (56 respondents). The group was young, well educated, and highly motivated. The failure rate was 16.9 per 100 women years (Pearl method), with inconsistent use and dislodgement being of major importance. The continuation rate was 75% (minimum 3 months of use), and 84% expressed satisfaction with the method. No significant side effects or risks to health were encountered. The conclusion is that there is a significant demand for alternative contraceptive methods among a select group of women. However, in the present state of knowledge, use of the cap should probably not be encouraged as a primary means of contraception, but should be reserved for those women with multiple contraceptive problems or for highly motivated women who seek out this means, understand its limitations, and can accept the relative uncertainty of its effectiveness. (AM. J. OBSTET. GVNECOl. 148:604, 1984.)
In recent years, the lay press and women's health groups have given much attention to the use of the
From the Department of Obstetrics, Gymcology and Reproductive Sciences, University of Manitoba. Presented at the Thirty-ninth Annual Meeting of The Society ofObstetricians and Gynaecologists of Canada, Vancouver, British Columbia, Canada, june 14-18,1983. Reprint requests: Joann M. Johnson, M.D., Department of Obstetrics, Gynecology and Reproductive Sciences, University of Manitoba, WinniPeg, Manitoba, Canada.
604
cervical cap as a contraceptive method. The cap has, however, continued to find only limited acceptance among medical professionals in this country. The reason for this reluctance is mainly a lack of data on its safety, efficacy, and clinical acceptability. To attempt to clarify this, a follow-up study was conducted by means of a questionnaire survey of 130 women fitted with a cervical cap over a 12-rnonth period. The study was designed to answer three questions. What is the effectiveness of the cap in a group of
Cervical cap 605
Volume 148 Number 5
Table II. Previous contraceptive experience
Table I. Characteristics of the group studied Characteristic
% of 56 respondents Method
Methods ever used by the 56 respondents (%)
Age* (yr) <20 20-24 25-29 30-34 ~35
Educationt (highest level attained) High school University Vocational training Employment (some responded to more than one category) Full-time Part-time Unemployed Student Homemaker Relationship status Married Single Common-law
7 43 34 16 0
Foam and condom Oral contraception Intrauterine contraceptive device Rhythm and natural Diaphragm Nonspecific
98 65 29 27 21 5
II 79 10
54 10
3 38 7 25 55 20
*A
total of 77% were in their twenties. t A total of 100% had completed high school.
women practicing contraception? What side effects are noted with such use? What is the overall applicability of the method? It is not surprising that most clinicians are unfamiliar with the contemporary use of the cervical cap. First described by Friedrich Wilde, a German gynecologist, in 1838, the cap was once the most widely used barrier method of contraception in Western Europe and England. '2 Although it never achieved the same popularity in North America, where most clinicians preferred to prescribe the diaphragm, there was a significant incidence of use of the cap between 1900 and 1940. However, with the advent of oral contraceptives, intrauterine devices, and improved techniques of surgical sterilization, its use declined to near extinction, until recently. Now, the increasing apprehension on the part of both medical and lay populations concerning the known and potential risks associated with these newer methods has resulted in renewed interest in the old barrier methods, including the cap. The present study was undertaken because there are very few data on this device, the design of which has changed little over the years.
Material and methods Between July 1, 1981, and June 30, 1983, 130 women were fitted with a cervical cap at the Women's Health Clinic in Winnipeg. These included those who attended the clinic specifically to request the cap, and those who came seeking contraceptive advice, were offered the cap, and agreed to its use.
Type of cap and spermicide used. The only cap used in this study was the Prentif cavity rim cervical cap (manufactured by Lamberts, Ltd., London, England), which is available in four sizes (22, 25, 28, and 31 mm in diameter). The Prentif cap is a thimble-shaped cup made of rubber, with a firm rim and flexible dome designed to retain spermicidal cream or jelly. The rim adheres to the cervix by suction at the vaginal fornices, and the dome covers the tip of the cervix. The Prentif cap was selected because it seemed to be the best available according to studies on fit, stability, and retention of spermicide. 2 All the women were advised to use spermicidal cream or jelly with the cap. No specific brand was recommended. Fitting techniques. Each patient was fitted with a cap and instructed in its use by a physician. She was allowed to practice self-insertion and removal, checked by the physician, until it was considered that she had mastered the technique. Additional counseling was provided as necessary, and all patients received a standard instruction sheet and were advised to return for follow-up at 3 months, or earlier if any difficulties were encountered. In addition, it was recommended that a back-up contraceptive method be used for the first 3 months, and that the cap should not be used during the menstrual period. The questionnaire. In September, 1982, these 130 women were mailed a questionnaire that contained 35 questions designed to determine pregnancy rates and causes, major and minor risks, annoyances and satisfactions. The date on which the cap was first prescribed and the date on which the questionnaire was received were taken as the beginning and ending dates for participation in the study. Data on safety, effectiveness, and acceptability obtained from the questionnaire are the basis of this report.
Results Of the 130 women to whom the questionnaire was sent, 56 responded (43%). In some instances, the reply to the questionnaire was incomplete. Characteristics of the group studied. Most of the patients were young, well educated, single, employed, and practicing intercourse with a regular partner
606 Johnson
March I, 1984 Am. J. Obstet. Gynecol.
Table III. Reasons for selecting the cap Order of importance
Percentage
Does not affect a woman's natural hormones Not usually felt by user or partner Does not interrupt foreplay or intercourse More natural method of birth control Teaches a woman more about her own body Does not require daily involvement Inexpensive
93 91 86
84 82 77 56
(Table I), Most had previously used one or more contraceptive methods (Table II). Seventy-seven percent of the women reported hear·ing about the cap through nonmedical sources of information, and most of them attended the clinic specifically to request it. Thirty percent of the group specifically expressed anti -oral contraceptive sentiments, and the nonhormonal and noninvasive nature of the cap ranked as the most important feature in influencing their selection of the method (Table III). Twenty-eight percent of the group had previously experienced one or more pregnancies, 46% of which had been terminated electively. Effectiveness. The incidence of pregnancy was calculated according to the Pearl pregnancy index, which is defined as: No. of pregnancies per 100 woman years of use = No. of unplanned pregnancies ------'---~-=---.- X 1,200 No. of woman months of observations The n umber of woman months of observation is defined as the sum of the months each woman used the contraceptive method until becoming pregnant or discontinuing use. The Pearl index provides a single measure of use effectiveness as a contraceptive method, and is expressed as the number of pregnancies to be expected in 100 woman years of use. There was a total of five unplanned pregnancies in 355 woman months of exposure, which yielded a Pearl index of 16.9 pregnancies per 100 woman years of exposure. V ser versus method failure. The major problem in evaluating the effectiveness of a barrier method is that failure rates depend so greatly on how reliably and carefully the method is used. Thus, it is useful to estimate how much of the observed failure rate is user rather than method failure. Three of the five women who became pregnant stated that they had failed to use the device consistently. This "user failure" calculated by the Pearl index was 10.4 pregnancies per 100 woman years of use. Two of these women were multiparous, and one had previously had two therapeutic abortions. Of the two women whose pregnancies could be attributed to method failure, one reported finding the cap dislodged, and no cause was identified in the other.
The method failure rate calculated by the Pearl index was 6.5 pregnancies per 100 woman years of use. Acceptability. The majority (84%) of women in this study expressed satisfaction with the cap. Most found it to be more convenient to use than other barrier methods, although 70% did initially experience mechanical difficulties (difficulty in locating the cervix, difficulty with insertion and/or removal, and discomfort with self-examination ). Seventy-five percent stated that their confidence in the method was affected by uncertainties in regard to its safety and effectiveness, and by fear of dislodgement. Twenty-three percent of the 39 respondents who checked consistently found the cap dislodged on one or more occasions. The 14 respondents who stopped using the cap gave as reasons (in decreasing order of importance) "too much trouble," unplanned pregnancy, and discomfort to self or partner. Odor was not a significant problem. In spite of these problems, the continuation rate was 75% at the time of the study. The majority stated that the method had no detrimental effect on sexual activity; and of those who noted an improvement, many stated that a sense of physical and psychologic well-being was responsible for this. They expressed relief from concerns in regard to oral contraceptives and their possible adverse side effects, and found it reassuring to know that they were having "natural" menstrual cycles. Safety. No significant risks to life or health were identified in this study. No local trauma to the cervix or vagina was reported. Of 35 women with previously documented vaginal infections (vaginitis, cervicitis), only seven experienced recurrence of infection. Among the other 21 women, three reported the development of an infection after using the cap. There were no cases of pelvic inflammatory disease and little, if any, net effect on the frequency of urinary tract infections. There were no disturbances in menstrual cycles.
Comment A select group of women who appeared to be highly motivated toward barrier contraception was studied. Their previous experience with other barrier methods, in particular the diaphragm, was high when compared to that reported in other studies,6 and their concern and awareness of the known and potential risks in regard to oral contraceptives and intrauterine devices were significant. The failure rate in this study was high compared to that in other reported studies. Failure rates vary considerably among different studies. The earliest studies, by Konikow (1921) and Yaros (1927), reported failure rates of 4.5% and 3.5%, respectively. However, since they calculated only percentage failure rates and did not consider the length of time of exposure, they are not comparable to other studies. 2 This is also true of a
Volume 148 Number 5
study by Zohdiates and associates,4 who, in a survey of 60 women, found eight unplanned pregnancies, but did not report woman months of use. The well-known study by Tietze and associates/ in 1953, with use of the Pearl index, reported failure of 7.6 per 100 woman years of use, and more recently, Koch and associates/ in Boston, in 1982, reported a failure rate by the Pearl index of 9.25 per 100 woman years of use. In a smaller study by Denniston,5 in 1980, a failure rate of eight per 100 women per 6 months was found, which could be extrapolated to 16 per 100 years. This is the only study in which the failure rate approximated that in the present study. Many factors contribute to these wide ranges of failure rates. The sample size, duration of study period, criteria for selection of suitable candidates, fitting and training techniques, protocols for use, and type of cap and spermicide used all vary among different providers of the cap. Koch2 reports that, since completion of his study, he rejects more than 50% of applicants for the cap because they fail to meet his stringent criteria. On the other hand, other providers of the cap give a cap to every applicant. This will obviously lead to poor fitting and higher rates of pregnancy and dissatisfaction. Equally variable failure rates are reported for the diaphragm, with a range from 1.9% to 19.6%.2 Since the present study was neither randomized nor comparative, it cannot be compared accurately with studies on the diaphragm. The two main factors identified in this study as contributing to the high failure rate were inconsistent use and dislodgement. Inconsistent use resulted in more than three quarters of the pregnancies and emphasizes the importance of screening for unreliable users. The previous contraceptive history of the "user" failure group suggests both high rates of fertility and previously unsuccessful contraceptive practices. Only one pregnancy was attributed to dislodgement; however, a significant number of users did report finding the cap dislodged on one or more occasions. That this likely contributes importantly to method failure has been reported in other studies. 4 Another im portant consideration in regard to method failure concerns the type of spermicide used. Koch 2 has suggested that there may be a higher failure rate associated with the use of creams ven~us jellies, because of the lower water solubility of the creams. As cervical secretions accumulate, they form a layer over the oilbased cream, thereby providing a safe passage for sperm which circumvent the rim of the cap. The more water-soluble jellies dissolve in the cervical secretions, thereby rendering them spermicidal. It may be advisable, therefore, to recommend jelly preparations over creams. The acceptability of the method was high in this
Cervical cap
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study, thereby reflecting a high tolerance among this group for the various annoyances and inconveniences the method imposes. There was a high rate of satisfaction and a high continuation rate. Most other authors have also reported high acceptability, including Koch, who reported that 91 % of 268 respondents were satisfied with the method. 3 Only Denniston5 has reported high rates of dissatisfaction, with the main causes being fear of dislodgement and discomfort to self or partner. In Koch's3 study, odor was the leading cause of discontinuation of use. This contrasts to the present study in which mechanical difficulties were identified as the major feature disliked about the cap. The most liked feature was the nonhormonal aspect and, also, the convenience of the method compared to other barrier methods. Of major concern is the length of time the cap can safely and effectively remain in place. Recommendations vary from 8 hours to the entire length of the intermenstruum. The effect of prolonged use of an occlusive device on the cervix is not well known, so that, generally, shorter insertion spans have been recommended. The manufacturer of the Prentif cap suggests that the cap be left in no more than 24 hours and be used in a manner similar to that of a diaphragm. In this study, it was recommended that the cap be left in place from a minimum of 8 hours to a maximum of 3 days. The use of a spermicidal agent is also controversial. It is not known whether the major protective effect of the cap is mechanical and chemical or primarily mechanical. In a study by Lehfeldt and associates/ the spermicidal activity of the cap's contents was tested after a period of 7 and 14 days. They found no detectable activity for jellies and minimal activity for creams. Since the women inserted their caps after menstruation, there would be no detectable activity at the time of ovulation-hence, the mechanical barrier attributed to the cap's effectiveness. The most common vaginal spermicide, nonoxynol-9, has been shown in rats and rabbits to be absorbed rapidly through the vaginal mucosa and to be excreted intact within 2 to 4 days.8 No data are available on what happens in humans under actual conditions, but, presumably, there is little local activity once absorption has occurred. Most providers of the cap recommend the use of spermicide, but this likely increases the cap's effectiveness only for this initial period. Spermicides were generally considered to be safe until a recent study by Jick and associates9 indicated that they may increase the incidence of certain birth defects. This requires further study. As can be seen, many questions in regard to the safety of the cap remain. However, the cap appears to pose no significant risk to life or health when used for the recommended spans of insertion. More research is needed in regard to the effects of prolonged use. It appears that the Prentif cap offers no significant
Johnson
advantage over the diaphragm, other than its small size. Both require professional fitting, with the cap requiring an average of 30 minutes for full explanation and fitting. Many proponents claim that a major advantage is the fact that it can be left on the cervix for longer periods of time than can the diaphragm. However, this is not recommended at present. It is encouraging that three major studies on the cap are now underway in the United States. The largest of these three is a comparative study between two types of caps and the standard diaphragm. The other two studies are devoted to designing an improved cervical cap. These studies will be invaluable additions to our current state of knowledge. With the renewed emphasis on safe, simple barrier methods, an improved cervical cap would be a welcome, versatile addition to the limited selection of vaginal contraceptives presently available.
REFERENCES 1. Tietze, c., Lehfeldt, H., and Libeman, H. C.: The effectiveness of the cervical cap as a contraceptive method, AM. J OBSTET. CYNECOL. 66:904, 1953. 2. Koch, J: The Prentif contraceptive cervical cap: A contemporary study of its clinical safety and effectiveness, Contraception 25: 135, 1982. 3. Koch, J: The Prentif contraceptive cervical cap: Ac-
March I, 1984 Am. J. Obstet. Gynecol.
4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
ceptability aspects and their implication for future cap design, Contraception 25:161, 1982. Zohdiates, K. P., Feinbloom, R. I., and Sagov, S. E.: Contraceptive use of cervical caps, New Engl. J Med. 304:915,1981. Denniston, C.: High rates of pregnancy and dissatisfaction mark first cervical cap trial, Fam. Plann. Perspect. 13:48, 1981. Tyner, L., and Bradshaw, L.: Barrier methods. Clin. Obstet. Cynecol. 6:79, 1979. Lehfeldt, H., Sobrero, A. J, and Inglis, W.: Spermicidal effectiveness of chemical contraceptives used with the firm cervical cap, AM. J. OBSTET. CYNECOL. 82:446, 1961. Chapvil, M., Eskelson, C. D., Stiffel, V., et al.: Studies on nonoxynol-9. II. Intravaginal absorption, distribution, metabolism and excretion, Contraception 22:325, 1980. Jick, H., Walker, A. M., Rothman, K. J, et al.: Vaginal spermicides and congenital disorders, JAMA 245:1329, 1981. Fairbanks, B., and Scharfman, B.: The cervical cap. Past and current experience, Women Health, 5:61, 1980. Smith, C.: The use of the cervical cap at the University of California at Berkeley, Am. Coli. Health Assoc. 29:93, 1980. Crafenberg, E., Dickenson, R. L.: Contraception control by plastic cervical cap, West J Surg 52:335, 1944. McBride, C., and Arthur, C.: Customized cervical cap, J. Nurse Midwifery, 25:33,1980. Shelton, A., and Taylor, R.: Pearl pregnancy index reexamined-Stili useful for trials of contraceptives, AM. J OBSTET. CYNECOL. 135:592, 1981. Tatum, H., and Connel-Tatum, E.: Barrier contraception: A comprehensive overview, Fertil. Steril. 36:1,1981.
Non-Hodgkin's lymphoma in Bartholin's gland: Case report and review of literature Leo Plouffe, Jr., M.D., Togas Tulandi, M.D., Arthur Rosenberg, M.D., and Alex Ferenczy, M.D. Montreal, Quebec, Canada Described in this report is a systemic lymphoma which had selectively involved the Bartholin gland. The true prevalence of this phenomenon is not known, but greater attention to these areas of the genital tract may uncover additional cases and provide better insight into the natural history of lymphomas that involve the lower female genital tract. (AM. J. OesTET. GVNECOL. 148:608, 1984.)
Involvement of the vulva and vagina by malignant lymphoma has been described frequently,I, 2 but From the Departments of Obstetrics and Gynecology, Medicine, and Pathology, The Sir Mortimer B. Davis-jewish General Hospital, and Faculty of Medicine, McGill University. Presented at the Thirty-ninth Annual Meeting of The Society of Obstetricians and Gynaecologists of Canada, Vancouver, British Columbia, Canada, june 14-18,1983. Reprint requests: Dr. Alex Ferenczy, Department of Pathology, Sir Mortimer B. Davis-Jewish General Hospital, 3755 Cote SteCatherine Road, Montreal, Quebec, Canada H3T 1E2.
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non-Hodgkin's lymphoma that involved Bartholin's glands has not been reported previously. We present here the first such case, with a review of the literature.
Case report In December, 1980, a non-Hodgkin's lymphoma was excised from the right breast of a 54-year-old Jewish woman. Computerized tomography showed bilateral para-aortic infrarenal lymphadenopathy. The patient responded well to high-dose doxorubicin, vincristine,