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At least 19 recordsLinked to original sources
PubMed1991

The cervical cap.

The cervical cap is a barrier contraceptive method with an efficacy similar to that of the diaphragm. It has several advantages over other barrier contraceptives. In particular, it can be left in place for up to 48 hours, and repeated applications of spermicide are not necessary, even if sexual intercourse occurs more than once. In addition, the side effects seen with other barrier methods do not occur with the cervical cap. In some women, Papanicolaou tests may become abnormal, especially during the first three months of cap use. Therefore, careful monitoring of cervical cap users is essential.

Contraceptive Devices, Female↗
PubMed1988

Fitting the cervical cap.

The cervical cap is now available for general use by American women. Several steps are necessary to select women who are good candidates for cap usage and to successfully fit the cap. Many women are not good candidates for the cap. The cap is generally not suitable for women who have recently become sexually active or who are first-time contraceptors. Many users are women who cannot use more widely available contraceptives. Successful cap use requires a highly motivated, persistent woman who will correctly insert and remove her cap. The size, shape, length, position and location of the cervix must be assessed by the clinician prior to fitting the cap. The cervix should be visually inspected for lesions or cervicitis and a Pap smear should be taken. After an initial cap is selected, the stability of the cap, gaps between the cap and cervix, areas of uncovered cervix and the adequacy of the suction seal should be assessed. The woman should be taught how to insert and remove the cap. Additionally, she should be instructed to use a backup method of contraception until she is sure that the cap will remain in place during sexual intercourse. Successful cap fitting requires a careful, methodical approach by the clinician and a carefully selected, highly motivated client. This article presents the steps of cervical cap fitting.

Contraceptive Devices, Female↗
PubMed1992

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↗
PubMed1989

Feminism and regulation collide: the Food and Drug Administration's approval of the cervical cap.

In May 1988, the Prentif Cavity Rim cervical cap, a barrier method of contraception, was approved by the Food and Drug Administration (FDA) for contraceptive purposes in the United States. This paper describes some of the events leading to the approval of the cervical cap as a contraceptive. Of major interest is the unprecedented involvement of the feminist health movement in clinic-based research, policy making, and distribution of the cervical cap. The recall of the Vimule cervical cap, the use of lay health workers in fitting an experimental device, and the feminist providers' response to the FDA's regulation of the cervical cap are detailed.

Contraceptive Devices, Female↗
PubMed1992

New condoms for men and women, diaphragms, cervical caps, and spermicides: overcoming barriers to barriers and spermicides.

Barriers and spermicides are being developed for the prevention of unwanted pregnancy and sexually transmitted infection. The inconvenience of current methods limits their acceptability and leads to higher user failure rates. New methods, such as female condoms, nonlatex male condoms, and new cervical caps are being developed: the Reality (Wisconsin Pharmacal, Jackson, WI) polyurethane vaginal pouch has already received conditional Food and Drug Administration approval for use in the United States. The material used in a Food and Drug Administration-approved nonallergenic glove is being tested for its effectiveness as a condom. In addition, the Fem Cap, a cervical cap that had a life table probability of failure within 1 year of 4.8%, is expected to be available within the next 2 years. It is important for clinicians to be informed of new options becoming available for those patients who may be good candidates for these barrier methods.

Contraceptive Devices↗
PubMed1986

The cervical cap for home artificial insemination.

The cervical cap was used in artificial insemination (husband) in the home by 63 couples. An overall pregnancy rate of 19% occurred regardless of the duration of use, and a rate of 44% was associated with use for at least six months or until pregnancy occurred. Comparison of pregnancy rates between those in the program and those who dropped out and conceived without therapy revealed no statistical difference.

Adult↗
PubMed1985

The cervical cap as a contraceptive alternative.

A recent resurgence in the United States of popular interest in the cervical cap has prompted reexamination of its safety and effectiveness as a contraceptive device. Despite widespread use in Europe, few studies are available for evaluation of this non-hormonal, non-invasive barrier method of contraception. The U.S. Food and Drug Administration classified the cap as a "significant risk device" and has limited dispensing of the cap to providers with Investigational Device Exemptions. Use and fitting of the cervical cap are described.

Contraceptive Devices, Female↗
PubMed1986

Longevity of Gynol II and Ortho Creme in the Prentif cervical cap.

A review of the literature yielded no scientific basis for current recommendations on the length of time spermicide-filled cervical caps can be worn while continuing to protect against pregnancy. Ten cervical cap users provided 99 samples of cap contents after a variety of insertion periods using Gynol II, Ortho Creme and vehicle controls. Testing for spermicidal effect was performed in the laboratory using quality semen from two donors and employing the Multiple Exposure Photography system of semen analysis. Criteria for determining spermicide effectiveness were developed. Results suggest that 3 to 4 days is the reasonable limit for cap use with Gynol II and 5 days with Ortho Creme, contrasted with 1 day limits for Gynol II and 2 day limits for Ortho Creme using existing criteria. Limited experience with samples exposed to semen in vivo suggest that spermicidal potency is not lost through repeated intercourse. Recommendations for validating these limits with clinical studies are made.

Adult↗
PubMed1986

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↗
PubMed1986

Cervical tissue uptake of all-trans-retinoic acid delivered via a collagen sponge-cervical cap delivery device in patients with cervical dysplasia.

The present study was undertaken to evaluate the systemic absorption and cervical tissue uptake of all-trans-retinoic acid (TRA), delivered via a collagen spongecervical cap delivery device in patients with intraepithelial cervical dysplasia. Ten patients with histologically proven mild or moderate cervical dysplasia were included in this pharmacologic study. The two TRA concentrations (0.05% and 0.372%) selected for study represent the starting and maximally tolerated doses used in phase I clinical trial. All-trans-retinoic-11-3H acid (3H-TRA, 500 mu Ci) was used to facilitate cervical tissue uptake studies. Cervical biopsies and post-treatment blood samples were obtained from each patient after TRA exposure. The uptake of TRA into cervical tissues four hours after drug administration was significantly increased at the maximally tolerated TRA dose. There was a rapid decrease in cervical tissue concentration of TRA at the 0.372% dose between 4 and 24 h after drug exposure, suggesting a relatively short elimination half-life of TRA in cervical tissues. HPLC analysis of post-treatment blood samples indicate that there was no systemic absorption of TRA after local cervical administration.

Administration, Topical↗
PubMedDate not supplied

[Adaptation of a cervical cap for human artificial insemination].

The authors have designed a cervical cap in plastic throught which artificial insemination can be practised. The material allows prolonged contact between semen and the cervical mucus. Tests carried out 24 hours after insemination have shown that after 159 inseminations there were mobile spermatozoa in the mucus in 145 cases.

Female↗
PubMed1989

Effectiveness of the cavity-rim cervical cap: results of a large clinical study.

From 1981-1988, 3433 women were fitted with a cavity-rim cervical cap in a Food and Drug Administration-approved study. The estimated first-year pregnancy risk was 11.3% (95% confidence limits 10.0-12.8), with risks of 8.3 and 3.8% for user and method failures, respectively. Women who were younger, less educated, and more sexually active, and who intended to have children in the future, had higher pregnancy risks. "Near-perfect" users, ie, individuals who wore the cap for a maximum of 72 hours, used spermicide 100% of the time, and did not report unprotected sexual intercourse, had half the first-year pregnancy risk of others (6.1 versus 11.9%). There were no serious medical or gynecologic complications associated with cap use, although over 20% of users reported problems with cap dislodgment during or after intercourse, cap malodor, or partner discomfort.

Adult↗
PubMedDate not supplied

Cervical cap homologous artificial insemination (AIH): the University of Florence experience.

We report our experience with artificial insemination with husband's semen (AIH) using cervical cap. Forty-four couples were admitted to our AIH program over a two-year period. In 4 couples, AIH was performed due to impotence or hypospadia, while in the remaining 40 couples indications for AIH were abnormal semen, poor post-coital test, anti-sperm antibodies, poor cervical mucus. Overall, six pregnancies were obtained (pregnancy rate = 15%) in the latter group; in particular, AIH was able to elicit pregnancy in 5 out of the 25 cases of abnormal semen (20%). Our data emphasize the importance of female factors associated with infertility since significantly higher pregnancy rates (45.4% versus 0%) were observed in subjects in whom these factors were absent.

Adult↗
PubMed1989

The Prentif cervical cap and Pap smear results: a critical appraisal.

An analysis from a randomized study has suggested that a larger percentage of Class III Pap smears appears among Prentif cervical cap users three months after initiation of use of the method than among diaphragm users. This suggestion has been the basis of a U.S. Food and Drug Administration (FDA) requirement that women seeking to use the cap have Pap smears taken before initiating use and again after three months of use. The data from the pivotal randomized study are reanalyzed here. No significant differences exist in the distributions of smears between cap and diaphragm users at three months or throughout the first year. The majority of cap users with "Class III" smears at three months did not have even mild dysplasia when subsequently evaluated by biopsy or colposcopy. This was also the case for diaphragm users classified as having grade III smears at three months. Other studies of the Prentif cap have not found conversions to Class III smears at one year. The requirement of a 3-month Pap smear is not only economically burdensome to potential users of the cap but appears to be without firm foundation in the original data or in our current views of cervical carcinogenesis.

Adult↗
PubMed1986

Phase II trial of beta-all-trans-retinoic acid for cervical intraepithelial neoplasia delivered via a collagen sponge and cervical cap.

Retinoids are effective suppressors of the phenotypic development of cancer in many animal systems, whether the process is initiated by chemical, physical or viral carcinogens. Cases of cervical intraepithelial neoplasia are excellent for studying the effectiveness of retinoids as chemopreventive agents because the process can be closely followed by serial colposcopic and pathologic (cytology or biopsy) means and changes in the condition safely monitored. We have previously conducted a phase I study of trans-retinoic acid (Tretinoin) given topically by a collagen sponge and cervical cap. A dose of 0.372% was selected for phase II trial. We have treated 20 patients with topical retinoic acid, and a complete response with total regression of disease was obtained in 50%. Systemic and cervical side effects were mild and vaginal side effects moderate but tolerable. These results provide a clinical basis for a randomized, double-blind phase III study to definitely answer the question of whether retinoic acid is an effective chemopreventive agent for cervical cancer.

Animals↗
PubMed1988

The cervical cap.

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Cervix Uteri↗