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The Prentif contraceptive cervical cap: a contemporary study of its clinical safety and effectiveness.

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.

Adult↗

The cervical cap.

Explore the source record for details and available documents.

Cervix Uteri↗

The Prentif contraceptive cervical cap: acceptability aspects and their implications for future cap design.

Patients in a private gynecological practice were offered the Prentif contraceptive cervical cap. The first 413 acceptors were sent a questionnaire covering in detail many of the aspects of their experience. The 371 responses contained a wealth of information concerned with safety, effectiveness and acceptability. Safety and effectiveness are dealt with in the companion article preceding, while the less serious risk factors that reduce the acceptability of the Prentif cap are presented and discussed herein. In order of descending frequency, these factors include: odor; difficulty removing; discomfort to partner; difficulty inserting; dislike of spermicide; discomfort to self; urinary discomforts; vaginal infections; vaginal discharge; and vaginal itching. The most attractive features of the cap, as compared with the diaphragm, were: increased convenience; greater safety; less interference with spontaneity; increased frequency of intercourse; and increased libido. Despite multiple problems with Prentif caps, 67.4% of the cap recipients were still using their caps after one year. However, this was among a select group of highly motivated women of above-average intelligence. The causes of cap acceptability problems are discussed along with probable future improvements in cap design that may solve them.

Adult↗

Studies of cervical caps: I. Vaginal lesions associated with use of the Vimule cap.

Prior to investigating the contraceptive efficacy of cervical caps, we undertook a preliminary study to evaluate potential side effects of these devices. Women who had not previously used a cap were randomly assigned to wear either a Vimule or Cavity Rim Cap (CRC) for as long as seven days. The Vimule cap caused lesions of the portio vaginalis ranging from erythematous impressions to abrasions and frank lacerations. There was variation in the degree of trauma depending, in part, on the size of the cap and duration of wear. Disruption of the epithelium occurred in eight of twelve Vimule users, but the lesions were sometimes difficult to see owing to their location. CRCs were worn by 20 women. This device sometimes left a "suction ring" on the cervix but did not disrupt the epithelium. Two of three long-term users of the Vimule cap who were also studied had unusual formations of the vaginal mucosa suggesting a proliferative reaction to chronic irritation. It is recommended that all women using a Vimule Cap be carefully re-examined and counseled about further use of the device according to the findings of the examination.

Adolescent↗

Contraception with the cervical cap: effectiveness, safety, continuity of use, and user satisfaction.

With the growing interest in barrier contraceptive methods, the cervical cap has come back into use in North America. We examined the cap's effectiveness, safety, continuity of use, and user satisfaction among 617 women who were fitted at a family planning clinic in Toronto, Canada, between May 1981 and November 1983. Follow-up information was available for 516 of these women. Using a life table analysis with Bayesian adjustment, the probability of becoming pregnant after 12 months of use was 0.166 with a standard error of 0.022. There is evidence that after 1 year of use the caps deteriorate and that this deterioration may increase the risk of pregnancy. Many of the women in this study were very satisfied with the cervical cap; however, such problems as dislodgement, discomfort to user and partner, difficulty with insertion and removal, and unpleasant odour affected acceptability and continuity of use. It is likely that these problems could be alleviated by improving the quality of or changing the materials, modifying the design to improve the fit, and providing a greater range of sizes.

Adolescent↗

The cervical cap.

The Prentif cavity rim (PCR) cervical cap offers American women a barrier method alternative that is safe, effective, and convenient. Despite its many advantages and benefits, disadvantages have been documented. These include limited availability and side effects, such as cap dislodgement, partner discomfort, and bad odor of the cervical cap. However, many women decide the benefits and advantages associated with the PCR cervical cap outweigh the risks and possible side effects, making it an appealing alternative.

Adult↗