Cervical Caps

Cervical caps are small, firm silicone cups that adhere to the cervix by suction. Four types of cervical cap are available internationally. The Prentif cap was approved by the U.S. Food and Drug Administration (FDA) in May 1988, but was voluntarily removed from the U.S. market by the manufacturer in March 2005. The only cervical cap currently available in the United States is the FemCap (Fig. 130-1). The FemCap is silicone based and shaped like a sailor’s hat. Initial efficacy studies of the FemCap were based on the first-generation product, which is no longer available. A Cochrane Database Review comparing the first-generation FemCap with the diaphragm found that the FemCap was less effective in preventing pregnancy. Fourteen percent of nulliparous women using the FemCap became pregnant during the first year with typical use; parous women had a 29% failure rate. The first-generation FemCap is now considered obsolete and has been replaced with a second-generation design. Although research on the effectiveness of the second-generation FemCap is limited, the typical failure rate is estimated to be 7.6%. Failure rates with perfect use are 2% to 4%. Dislodgement of the first-generation device occurred in one third of users; the second-generation FemCap dislodgement rate is estimated at 2%. Future studies should better clarify long-term efficacy. The cap has a high level of patient acceptability, and FemCap users may have decreased risk of urinary tract infections compared with women using a diaphragm. The Prentif cap was associated with cervical dysplasia when the device was used for longer than 3 months. Although small trials do not link cytologic abnormalities with FemCap use, baseline Papanicolaou screening (Pap smear) and annual surveillance are reasonable in women choosing this method.

Figure 130-1 The FemCap cervical cap.

(Courtesy of FemCap, Inc., Del Mar, Calif; with permission.)

Anatomy

The FemCap has a dome that fits over the cervix. An asymmetric brim flares outward to fit against the vaginal fornices (see Fig. 130-1).

Indications

• Prevention of pregnancy

• Possible protection against STIs

Precautions

• Perform a pelvic examination before a cervical cap fitting. A Pap smear is recommended at baseline and then annually. Cervical cultures should be obtained in women at risk for STIs.

• Cervical cap fitting is contraindicated during pregnancy or the postpartum period (10 weeks).

Patient Education: Cervical Cap Use for Contraception

• Before use, one third of the inner side of the dome should be filled with spermicidal jelly.

• The jelly should not be applied to the inner surface of the rim.

• The cap may be inserted at any time from immediately before intercourse up to 40 hours before intercourse. It is most easily inserted in a squatting or semireclining position.

• The cap should be left in place for at least 6 hours following intercourse.

• The cap may be left in place for up to 48 hours.

• If intercourse occurs more than once while the cap is in place, no additional spermicide is needed. However, the wearer should check for correct positioning of the cap before each episode.

• An additional contraceptive method should be used the first three times the cap is worn during intercourse (to ensure protection should the cap become dislodged). If dislodgement occurs, cap use should be discontinued and the cap should be refitted.

• The cap should not be used during menses.

• Refitting is necessary after abortion or childbirth.

• The cap should not be used in the presence of vaginal infection, discharge, pain, or odor. If these occur, medical evaluation is necessary.

• If lubrication is needed for intercourse, only water-based lubricants should be used. (Spermicide works well for this purpose.)

• The cap should be washed carefully after use with soap and water. If an odor develops, it can be soaked in vinegar or a cup of water with a teaspoon of lemon juice. Alternatively, the cap can be cleaned with a 25% bleach solution for 20 minutes, after which it should be rinsed thoroughly.

• A Pap smear should be taken 3 months after beginning use of the cap. If this is negative, then a Pap smear should be obtained every year thereafter.

• The cap should be replaced yearly (sooner if thin spots or tears occur). The patient should make an appointment with her physician to check if it still fits adequately.

• If the cervical cap is used properly, 6% of women will become pregnant after using the device for a year.

• If the device is left in too long, infections can occur, so the patient must follow the previously listed guidelines.

Procedure

1 Review the instructions from the FemCap kit.

2 Put on gloves and select the appropriate size of FemCap (described in the equipment section).

3 Lubricate the edges of the device, compress it, and insert vaginally. The FemCap should be inserted with the long brim first and pushed into the vagina until the dome fits snugly over the cervix (Fig. 130-2).

4 The cap should cover the entire cervix and adhere to it by self-generated suction.

5 The rim of the cap should fit evenly around the circumference of the vaginal fornices.

6 No gaps should be felt between the rim of the cap and the cervix.

7 Tug gently on the removal strap to guarantee that the cap will not dislodge.

8 If the cap does not fit satisfactorily, try one of the other two sizes.

9 Remove the cap by gripping the strap and rotating the FemCap. Push on the dome to break the suction and pull the cap out using the strap.

10 Have the patient repeat the insertion and removal process to demonstrate understanding.

Figure 130-2 Proper placement and positioning of the FemCap.

(Courtesy of FemCap, Inc., Del Mar, Calif; with permission.)

Postprocedure Management

The patient should sit and also ambulate to ensure that the cap does not dislodge. No discomfort should be noted when the cap is correctly applied.

Shield

Lea’s shield is a one-size silicone barrier (Fig. 130-3). It has a valve that allows for passage of cervical secretions while the shield is in place. The device was FDA approved in 2002; data on efficacy of Lea’s shield are limited to one 6-month clinical trial. The 6-month pregnancy rate in this study was 5.6 per 100 when spermicide was used and 9.3 per 100 without spermicide. Women who are parous have slightly higher failure rates with this method. Shield dislodgement occurs in less than 3% of users.