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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↗

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↗

Preliminary findings on used cervical caps.

Rubber cervical caps (Lambert-Dalston), used for periods of time ranging from 1 month to 3 years, were collected and assessed for deterioration and contamination as part of a product safety and efficacy study. Examination at magnification of 10 to 30 times as well as evaluation of surface damage and bulk mechanical properties revealed significant deterioration on all caps used consistently for more than one year. Changes were also evident on caps worn for shorter periods. Potential for adverse reaction from rubber degradation products and contamination adsorbed from disinfecting agents does not appear negligible. This problem, in combination with the inability to satisfactorily clean the caps after use, further limits their clinical value. A rethinking of cap design and the choice of better cap materials appears necessary to minimize long-term user problems and to mitigate product-related aesthetic deficiencies of this fertility control method.

Consumer Product Safety↗

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↗

The cervical cap: an alternative contraceptive.

The cervical cap is a convenient, inexpensive, nonhormonal and non-invasive contraceptive method. This method has potential for better effectiveness if custom-fit caps are manufactured. As more health care providers become knowledgeable in the use of the cap, more women will become aware of this contraceptive method as an alternative to oral contraceptives and intrauterine devices. Research is needed to document the most accurate method of cervical cap fitting and the effectiveness rate of the cervical cap. Nurse practitioners who counsel patients and fit them for caps are in the perfect position to start doing this research.

Contraceptive Devices, Female↗

Cervical cap versus diaphragm for contraception.

BACKGROUND: The cervical cap and the diaphragm are vaginal barrier contraceptive methods that prevent pregnancy by covering the cervix. The two devices also act as a reservoir for spermicide. The cervical cap is smaller and can remain in place longer than the diaphragm. Two types of cervical caps, the Prentif cap and the FemCap, have been compared to the diaphragm in randomized controlled trials. OBJECTIVES: The review seeks to evaluate the contraceptive efficacy, safety, discontinuation, and acceptability of the cervical cap with that of the diaphragm. SEARCH STRATEGY: We searched MEDLINE, Popline, Cochrane Controlled Trials Register, EMBASE, and LILACS for randomized controlled trials of cervical caps, and we reviewed the references of the included publications. Also, we wrote to the manufacturers and known investigators to request information about any other published or unpublished trials not found in our search. SELECTION CRITERIA: All randomized controlled trials in any language comparing a cervical cap with a diaphragm were eligible for inclusion. DATA COLLECTION AND ANALYSIS: All titles and abstracts located in the literature searches were assessed, and articles identified for inclusion were independently abstracted by two reviewers. Data were entered and analyzed with RevMan 4.1, and a second reviewer verified the data entered. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Outcomes were calculated as Peto odds ratios with 95 percent confidence intervals using women as the denominators. Life-table and Kaplan-Meier cumulative rate ratios for selected measures were also presented in "Additional Tables." MAIN RESULTS: The Prentif cap was comparable to the diaphragm in preventing pregnancy, but the FemCap was not as effective in preventing pregnancy as its comparison diaphragm. The curves for the life-table cumulative pregnancy rates through 24 months for the Prentif cap and the diaphragm were not statistically significantly different (p-value of 0.39). However, the six-month Kaplan-Meier cumulative pregnancy rates for the FemCap and the diaphragm did not meet the a priori definition of clinical equivalence. The Prentif cap had a higher proportion of Class I to Class III cervical cytologic conversions at the three-month visit than the diaphragm; the odds ratio was 2.3 (95% CI, 1.0-5.1). The FemCap trial did not find differences in Papanicolaou smear results between the cap and diaphragm groups. Prentif cap users had a lower odds ratio of vaginal ulcerations or lacerations (0.3; 95% CI, 0.1-0.7) than diaphragm users. FemCap users had a higher odds ratio of blood in the device on removal (2.3; 95% CI, 1.3-4.1), but a lower odds ratio of urinary tract infections (0.6; 95% CI, 0.4-1.0) than those in the diaphragm group. In the FemCap trial, similar proportions of women reported liking their assigned device "somewhat" or "a lot" at the two-week interview. However, FemCap users were less likely than the diaphragm users to state that they were "probably" or "definitely" likely to use the device alone after completing the trial (odds ratio of 0.5; 95% CI, 0.3-0.7) or that they would recommend it to a friend (odds ratio of 0.5; 95% CI, 0.3-0.8). REVIEWER'S CONCLUSIONS: The Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but the FemCap was not. Both cervical caps appear to be medically safe.

Adult↗

A phase I trial of beta-all-trans-retinoic acid delivered via a collagen sponge and a cervical cap for mild or moderate intraepithelial cervical neoplasia.

A phase I trial was conducted of the vitamin A derivative beta-all-trans-retinoic acid (vitamin A acid; TRA), delivered via a collagen sponge and cervical cap for mild or moderate intraepithelial cervical neoplasia. On the basis of known skin and mucosal membrane toxicity, a concentration of 0.05% TRA in a cream-based vehicle was selected as the starting dose and was escalated later with the use of a modified Fibonacchi scale. The delivery device and the TRA were changed daily for 4 days, and side effects were assessed on days 1, 2, 3, 4, 8, and 30 by clinical and colposcopic examination. Vaginal, cervical, and systemic toxicity were evaluated in 35 patients. No dose-related systemic effects were found; mild cervical inflammation increased in many patients at higher doses. Unacceptably high vaginal toxicity was reached at a TRA concentration of 0.484%. A concentration of 0.372% TRA is recommended for use in phase II trials in mild and moderate cervical intraepithelial neoplasia.

Biopsy↗

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↗

Does intrauterine insemination offer an advantage to cervical cap insemination in a donor insemination program?

OBJECTIVE: To compare pregnancy outcome after IUI versus cervical cap insemination in a donor insemination program. DESIGN: A randomized prospective clinical trial in which patients were alternately inseminated with cryopreserved human semen using either IUI or cervical cap insemination methods. SETTING: The donor insemination program at Washington University School of Medicine. PATIENTS: Forty-two women with either isolated male factor or male factor plus corrected ovulatory dysfunction using clomiphene citrate underwent 141 cycles of donor insemination. MAIN OUTCOME MEASURES: Clinical pregnancy rates (PRs) defined as a viable intrauterine gestation > 12 weeks or delivered were compared between groups using the chi 2 test. RESULTS: Clinical PRs were significantly higher in the IUI group (16.4%) compared with the cervical cap insemination group (5.9%). The spontaneous abortion rates were similar between the IUI (1.4%) and cervical cap insemination groups (4.4%). CONCLUSIONS: These findings suggest an advantage to IUI over cervical cap insemination in a donor insemination program.

Abortion, Spontaneous↗

The use of cervical caps at the University of California, Berkeley: a survey.

A survey of cap use and efficacy of women who initially purchased a cervical cap at the University of California at Berkeley Student Health Service is described. It reports the follow-up of 65 U.C. women students who purchased either Vimule or Cavity-rim cervical caps from May, 1978 through June, 1981 and raises questions about cervical cap use and efficacy. Participants were divided into two groups: regular and irregular users. Of the 33 regular users, 16 experienced unplanned pregnancy during the study. Survival probabilities were 80% at 6 months, 73% at one year and 52% after 2 years. Life table analysis of the 33 regular users indicated a 20% probability of pregnancy in the first 6 months of use, 27% by 1 year and 48% by the end of 2 years.

Adolescent↗

A prospective, randomized, cross-over comparison of two methods of artificial insemination by donor on the incidence of conception: intracervical insemination by straw versus cervical cap.

In a prospective, randomized study of insemination with donor semen, intracervical insemination by straw was compared with insemination using a cervical cap with an intracervical reservoir. A total of 91 patients completed 486 treatment cycles. There were no significant differences in age, parity, indication for insemination by donor, or method of cycle monitoring between women who became pregnant and those who did not conceive with either insemination method. In 236 standard intracervical insemination cycles, 14 patients became pregnant (5.9% per cycle), whereas 38 patients conceived in 250 cervical cap cycles (15.2% per cycle). Both the crude pregnancy rates and the cumulative pregnancy rates calculated by the Kaplan-Meier life-table method were significantly different (chi(2)-test, P < 0.001, and log-rank test, P < 0.005 respectively). Pregnancy rates in artificial insemination with cryopreserved donor semen may be improved by the use of a cervical cap when compared to cervical insemination by straw. The use of the cervical cap may prolong the exposure of the spermatozoa to the cervical mucus and prevent the backflow of semen into the vagina.

Body Temperature↗

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↗

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↗

Contraceptive efficacy of the diaphragm, the sponge and the cervical cap.

A reanalysis of data from two clinical studies--in which 1,439 women were randomly assigned to use either the contraceptive sponge or the diaphragm and 1,394 women were randomly assigned to use either the cervical cap or the diaphragm--found first-year probabilities of failure during typical use of 17% for the sponge, 18% for the cervical cap and 13-17% for the diaphragm. The first-year probabilities of failure during perfect use are 11-12% for the sponge, 10-13% for the cervical cap and 4-8% for the diaphragm. The probability of failure during perfect use is significantly higher among women who have given birth than among those who have not for users of the sponge (19-21% vs. 9-10%) and users of the cervical cap (26-27% vs. 8-10%), but not for users of the diaphragm.

Contraceptive Devices, Female↗

Evaluation of the effect of a cervical cap device on sperm functional characteristics in vitro.

Intracervical insemination continues to be employed for homologous and donor insemination in natural and stimulated cycles. Efficacy studies for potential fertility involve in vivo assessment; however, in vitro testing of particular sperm function(s) critically involved in fertilization is an important component of such evaluation. We report here on the in vitro evaluation of the effects of the silicone Veos cervical cap (Veos, London, UK) on sperm function. Donor semen was exposed to the Veos cervical cap or a sterile 15-cc centrifuge tube (control), or treated with the spermicide nonoxynol-9 (5 mg x ml(-1) in saline) for 4 h at 37 degrees C and 5% CO2 in water-saturated air. After exposure, motility characteristics, both in semen and in spermatozoa processed by standard swim-up procedure, cervical mucus penetration and sperm-zona pellucida interaction using the hemizona assay were assessed. Results indicated that exposure to the Veos cervical cap had no effect on either sperm motility characteristics or sperm-zona pellucida interaction. A small but significant difference was observed for cervical mucus penetration (P = 0.05); however, for both the control and treated groups, vanguard spermatozoa exceeded manufacturer's guidelines for a normal test, a penetration distance of > or = 30 mm. As expected, nonoxynol-9 was a potent inhibitor of sperm function. Lack of adverse effects on in vitro spermatozoa functional characteristics after exposure to the silicone Veos cervical cap supports its addition to the repertoire of fertility treatment modalities when cervical insemination is indicated.

Cervix Mucus↗

The cervical cap: past and current experience.

In the past several years, a new trend has emerged where women in increasingly growing numbers are becoming hesitant to accept the risks associated with hormonal and invasive methods of birth control. It is as part of this trend that a revival of sorts is occurring with the cervical cap, a form of birth control with roots which precede recorded history and which, in its modern form, was widely advocated in late 19th and early 20th century Europe. Based on the principle of occlusion, the cervical cap appears effective and risk-free, both vital concerns to women of all centuries. Women's health activists and organizations have been in the forefront of this revival. Two of the first organizations to take an active interest in making the cap available were the New Hampshire Feminist Health Center in Concord, New Hampshire, and the Emma Goldman Women's Health Clinic in Iowa City, Iowa. The National Women's Health Network, a national organization based in Washington, D.C., has also been an active advocate on the cervical cap's behalf.

Contraceptive Devices, Female↗

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↗

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↗