Femcap Cervical Cap

FEMCAP CERVICAL CAP

DEFINITION FemCap is the only cervical cap available in the U.S. The FemCap is a small bowl- shaped silicone cup with a brim that flares outward. The concave side of the cap covers the cervix completely. The brim is taller on one side to aid proper positioning, the larger brim fitting into the posterior vagina. The cervical cap is designed for use with spermicide, placed in the bowl and around the brim. FemCap has a small strap over its dome to facilitate removal. It is available by prescription in three sizes, which are based on the woman’s obstetrical history. No formal sizing is needed. FemCap can be kept in place for up to 48 hours. The first year failure rate in typical use is about 18% but if used correctly and consistently may have a failure rate of about 6%. FemCap may also help to reduce the risk of STIs which infect the cervix and upper genital tract. However, this barrier protection may be offset by the Nonoxynol-9 (N-9) spermicide that is used with the device which may increase a woman’s vulnerability to HIV infection, especially if she requires multiple applications daily.

SUBJECTIVE Must include: 1. LNMP and menstrual history 2. Medical, sexual, and contraceptive use history 3. Obstetric history (nulligravidus, nulliparous, parous) to determine the size FemCap. 4. Zika Risk Assessment a. Travel-self and partner(s) 1) Past travel –last 8 months –where and when 2) Plans for future travel –where and when

Must exclude: All CDC category 4 conditions – (unacceptable risk for method use). Use caution with CDC category 3 conditions - (risks outweigh advantages for method use) management must be based on protocols approved by Medical Director or clinical physician. 1. History of Toxic Shock Syndrome (TSS) CDC 3) 2. Allergy to product components (CDC 3) 3. High risk for HIV/AIDS (CDC 4) 4. Cervical cancer or cervical intraepithelial neoplasia (CDC 4) 5. HIV/AIDS (CDC 3) 6. Antiretroviral (ARV) therapy (CDC 3) 7. Vaginal delivery or cervical surgery or treatments within previous 6 weeks 8. 2nd Trimester abortion within previous 6 weeks

May exclude: 1. Inability or unwillingness to touch genitals. 2. Severe obesity may make correct placement difficult. 3. History of frequent urinary tract infections. Use of cervical cap and spermicides may increase risk of urinary tract infection 4. Risk of cap failure is higher in parous women than in nulliparous women

1 2 OBJECTIVE Must exclude: 1. Anatomical abnormalities (Cervical cap is not appropriate for women with markedly distorted cervical anatomy) 2. Cervical erosions or lacerations 3. Inability to be properly fitted with the FemCap

May exclude: 1. Markedly anteverted or retroverted uterus.

LABORATORY Consider Zika screening if indicated by Zika Risk Assessment.

ASSESSMENT Candidate for FemCap cervical cap

PLAN 1. Provide properly sized cervical cap based on patient’s obstetrical history, i.e. nulliparous (never pregnant for more than 20 weeks); nulligravidous (never pregnant); or parous. 2. Have patient demonstrate ability to correctly apply correct amount of spermicidal gel and to place and remove FemCap cervical cap. 3. Instruct patient to RTC for annual exam, after each pregnancy, after treatment for cervical dysplasia and PRN problems. 4. Offer methods of emergency contraception in advance of need (see Emergency Contraception [EC] protocol). 5. Suggest that partner use condoms to increase contraceptive efficacy and STI protection.

PATIENT EDUCATION 5. Counsel patient on proper use, removal, cleansing, and storage of FemCap cervical cap. a. FemCap can be placed up to 6 hours prior to intercourse. b. The cap should be left in place at least 6 hours after the last act of intercourse. c. The cap should be left vaginally for no longer than 48 hours. d. Provide instructions about the appropriate amounts of spermicide to use. 6. Remind patient to avoid using during menstruation. 7. Advise against using FemCap while being treated for any cervical infection but recommend use of another barrier method. 8. Advise patient to seek immediate medical care if: a. She is unable to remove the cap b. She experiences unexpected bleeding, cramping, vaginal discharge or other symptoms of vaginal or cervical infection or irritation (if any of these problems develops, a patient should promptly stop using FemCap). 9. Instruct patient that if the cervical cap dislodges with coital activity, she should immediately apply spermicide and consider using hormonal methods of emergency contraception (see Emergency Contraception [EC] protocol). 10. Zika virus education and prevention strategies a. Avoid traveling to impacted areas

3 b. Avoiding mosquito bites if traveling to impacted areas c. Using condoms to prevent transmission of virus d. Avoiding pregnancy if infected or partner infected d.i.1) Risk to unborn fetus

REFER to MD/ER Signs or symptoms of Toxic Shock Syndrome

REFERENCES 1. Centers for Disease Control and Prevention (CDC). U.S. Medical Eligibility Criteria for Contraceptive Use, 2016 available at h ttp://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6503.pdf 2. Centers for Disease Control and Prevention (CDC). Zika Virus Homepage- http://www.cdc.gov/zika/index.html 3. Hatcher RA, et al (editors). Contraceptive Technology, 20th Ed. New York: Ardent Media. 391-408.

Reviewed/Revised 2018