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Appendix G

Classifications for Barrier Methods


Classifications for barrier contraceptive methods include those for condoms, which include male latex condoms, male polyurethane condoms, and female condoms; spermicides; and diaphragm with spermicide or cervical cap (Box). Consistent and correct use of the male latex condom reduces the risk for STI/HIV transmission.

Women with conditions that make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of the relatively higher typical-use failure rates of these methods.

BOX. Categories for Classifying Barrier Methods

1 = A condition for which there is no restriction for the use of the contraceptive method.

2 = A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.

3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method.

4 = A condition that represents an unacceptable health risk if the contraceptive method is used.

TABLE. Classifications for barrier methods,*† including condoms, spermicides, and diaphragms/caps

Condition

Category

Clarifications/Evidence/Comments

Condom

Spermicide

Diaphragm/cap

Personal Characteristics and Reproductive History

Pregnancy

Not applicable

Not applicable

Not applicable

Clarification: None of these methods are relevant for contraception during known pregnancy. However, for women who remain at risk for STI/HIV during pregnancy, the correct and consistent use of condoms is recommended.

Age

a. Menarche to <40 yrs

1

1

1

b. ≥40 yrs

1

1

1

Parity

a. Nulliparous

1

1

1

b. Parous

1

1

2

Clarification: Risk for cervical cap failure is higher in parous women than in nulliparous women.

Postpartum

a. <6 wks postpartum

1

1

Not applicable

Clarification: Diaphragm and cap are unsuitable until uterine involution is complete.

b. ≥6 wks postpartum

1

1

1

Postabortion

a. First trimester

1

1

1

b. Second trimester

1

1

1

Clarification: Diaphragm and cap are unsuitable until 6 weeks after second trimester abortion.

c. Immediate postseptic abortion

1

1

1

Past ectopic pregnancy

1

1

1

History of pelvic surgery

1

1

1

Smoking

a. Age <35 yrs

1

1

1

b. Age ≥35 yrs

i. <15 Cigarettes/day

1

1

1

ii. ≥15 Cigarettes/day

1

1

1

Obesity

Comment: Severe obesity might make diaphragm and cap placement difficult.

a. ≥30 kg/m2 BMI

1

1

1

b. Menarche to <18 yrs and ≥30 kg/m2 BMI

1

1

1

History of bariatric surgery§

a. Restrictive procedures: decrease storage capacity of the stomach (vertical banded gastroplasty, laparoscopic adjustable gastric band, laparoscopic sleeve gastrectomy)

1

1

1

TABLE. (Continued) Classifications for barrier methods,*† including condoms, spermicides, and diaphragms/caps

Condition

Category

Clarifications/Evidence/Comments

Condom

Spermicide

Diaphragm/cap

b. Malabsorptive procedures: decrease absorption of nutrients and calories by shortening the functional length of the small intestine (Roux-en-Y gastric bypass, biliopancreatic diversion)

1

1

1

Cardiovascular Disease

Multiple risk factors for arterial cardiovascular disease (such as older age, smoking, diabetes, and hypertension)

1

1

1

Hypertension

a. Adequately controlled hypertension

1

1

1

b. Elevated blood pressure levels (properly taken measurements)

i. Systolic 140--159 mm Hg or diastolic 90--99 mm Hg

1

1

1

ii. Systolic ≥160 mm Hg or diastolic ≥100 mm Hg§

1

1

1

c. Vascular disease

1

1

1

History of high blood pressure during pregnancy (where current blood pressure is measurable and normal)

1

1

1

Deep venous thrombosis (DVT)/pulmonary embolism (PE)

a. History of DVT/PE, not on anticoagulant therapy

i. Higher risk for recurrent DVT/PE (≥1 risk factors)

• History of estrogen-associated DVT/PE

• Pregnancy-associated DVT/PE

• Idiopathic DVT/PE

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, on therapy, or within 6 mos after clinical remission), excluding non-melanoma skin cancer

• History of recurrent DVT/PE

1

1

1

ii. Lower risk for recurrent DVT/PE (no risk factors)

1

1

1

b. Acute DVT/PE

1

1

1

c. DVT/PE and established on anticoagulant therapy for at least 3 mos

i. Higher risk for recurrent DVT/PE (≥1 risk factors)

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, on therapy, or within 6 mos after clinical remission), excluding non-melanoma skin cancer

• History of recurrent DVT/PE

1

1

1

ii. Lower risk for recurrent DVT/PE (no risk factors)

1

1

1

d. Family history (first-degree relatives)

1

1

1

e. Major surgery

i. With prolonged immobilization

1

1

1

ii. Without prolonged immobilization

1

1

1

f. Minor surgery without immobilization

1

1

1

Known thrombogenic mutations§ (e.g., factor V Leiden; prothrombin mutation; protein S, protein C, and antithrombin deficiencies)

1

1

1

Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening.

TABLE. (Continued) Classifications for barrier methods,*† including condoms, spermicides, and diaphragms/caps

Condition

Category

Clarifications/Evidence/Comments

Condom

Spermicide

Diaphragm/cap

Superficial venous thrombosis

a. Varicose veins

1

1

1

b. Superficial thrombophlebitis

1

1

1

Current and history of ischemic heart disease§

1

1

1

Stroke§ (history of cerebrovascular accident)

1

1

1

Known hyperlipidemias

1

1

1

Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening.

Valvular heart disease

a. Uncomplicated

1

1

1

b. Complicated§ (pulmonary hypertension, risk for atrial fibrillation, history of subacute bacterial endocarditis)

1

1

2

Peripartum cardiomyopathy§

a. Normal or mildly impaired cardiac function (New York Heart Association Functional Class I or II: patients with no limitation of activities or patients with slight, mild limitation of activity) (1)

i. <6 mos

1

1

1

ii. ≥6 mos

1

1

1

b. Moderately or severely impaired cardiac function (New York Heart Association Functional Class III or IV: patients with marked limitation of activity or patients who should be at complete rest) (1)

1

1

1

Rheumatic Diseases

Systemic lupus erythematosus§

a. Positive (or unknown) antiphospholipid antibodies

1

1

1

b. Severe thrombocytopenia

1

1

1

c. Immunosuppressive treatment

1

1

1

d. None of the above

1

1

1

Rheumatoid arthritis

a. On immunosuppressive therapy

1

1

1

b. Not on immunosuppressive therapy

1

1

1

Neurologic Conditions

Headaches

a. Non-migrainous (mild or severe)

1

1

1

b. Migraine

i. Without aura

• Age <35 yrs

1

1

1

• Age ≥35 yrs

1

1

1

ii. With aura, at any age

1

1

1

Epilepsy§

1

1

1

Depressive Disorders

Depressive disorders

1

1

1

Reproductive Tract Infections and Disorders

Unexplained vaginal bleeding (suspicious for serious condition)

Before evaluation

1

1

1

Clarification: If pregnancy or an underlying pathological condition (such as pelvic malignancy) is suspected, it must be evaluated and the category adjusted after evaluation.

Endometriosis

1

1

1

Benign ovarian tumors (including cysts)

1

1

1

Severe dysmenorrhea

1

1

1

TABLE. (Continued) Classifications for barrier methods,*† including condoms, spermicides, and diaphragms/caps

Condition

Category

Clarifications/Evidence/Comments

Condom

Spermicide

Diaphragm/cap

Gestational trophoblastic disease

a. Decreasing or undetectable β--hCG levels

1

1

1

b. Persistently elevated β-hCG levels or malignant disease§

1

1

1

Cervical ectropion

1

1

1

Cervical intraepithelial neoplasia

1

1

1

Clarification: The cap should not be used. Diaphragm use has no restrictions.

Cervical cancer (awaiting treatment)

1

2

1

Clarification: The cap should not be used. Diaphragm use has no restrictions.

Comment: Repeated and high-dose use of nonoxynol-9 can cause vaginal and cervical irritation or abrasions.

Breast disease

a. Undiagnosed mass

1

1

1

b. Benign breast disease

1

1

1

c. Family history of cancer

1

1

1

d. Breast cancer§

i. Current

1

1

1

ii. Past and no evidence of current disease for 5 yrs

1

1

1

Endometrial hyperplasia

1

1

1

Endometrial cancer§

1

1

1

Ovarian cancer§

1

1

1

Uterine fibroids

1

1

1

Anatomical abnormalities

1

1

Not applicable

Clarification: The diaphragm cannot be used in certain cases of prolapse. Cap use is not appropriate for a woman with markedly distorted cervical anatomy.

Pelvic inflammatory disease (PID)

a. Past PID (assuming no current risk factors of STIs)

i. With subsequent pregnancy

1

1

1

ii. Without subsequent pregnancy

1

1

1

b. Current PID

1

1

1

STIs

a. Current purulent cervicitis or chlamydial infection or gonorrhea

1

1

1

b. Other STIs (excluding HIV and hepatitis)

1

1

1

c. Vaginitis (including Trichomonas vaginalis and bacterial vaginosis)

1

1

1

d. Increased risk for STIs

1

1

1

HIV/AIDS

High risk for HIV

1

4

4

Evidence: Repeated and high-dose use of the spermicide nonoxynol-9 was associated with increased risk for genital lesions, which might increase the risk for HIV infection (2).

Comment: Diaphragm use is assigned Category 4 because of concerns about the spermicide, not the diaphragm.

HIV infection§

1

3

3

Comment: Use of spermicides and/or diaphragms (with spermicide) can disrupt the cervical mucosa, which may increase viral shedding and HIV transmission to uninfected sex partners.

AIDS§

1

3

3

Comment: Use of spermicides and/or diaphragms (with spermicide) can disrupt the cervical mucosa, which may increase viral shedding and HIV transmission to uninfected sex partners

Other Infections

Schistosomiasis

a. Uncomplicated

1

1

1

b. Fibrosis of liver§

1

1

1

Tuberculosis§

a. Nonpelvic

1

1

1

b. Pelvic

1

1

1

TABLE. (Continued) Classifications for barrier methods,*† including condoms, spermicides, and diaphragms/caps

Condition

Category

Clarifications/Evidence/Comments

Condom

Spermicide

Diaphragm/cap

Malaria

1

1

1

History of toxic shock syndrome

1

1

3

Comment: Toxic shock syndrome has been reported in association with contraceptive sponge and diaphragm use.

Urinary tract infection

1

1

2

Comment: Use of diaphragms and spermicides might increase risk for urinary tract infection.

Endocrine Conditions

Diabetes

a. History of gestational disease

1

1

1

b. Nonvascular disease

i. Noninsulin-dependent

1

1

1

ii. Insulin-dependent§

1

1

1

c. Nephropathy/retinopathy/neuropathy§

1

1

1

d. Other vascular disease or diabetes of >20 yrs' duration§

1

1

1

Thyroid disorders

a. Simple goiter

1

1

1

b. Hyperthyroid

1

1

1

c. Hypothyroid

1

1

1

Gastrointestinal Conditions

Inflammatory bowel disease (ulcerative colitis, Crohn disease)

1

1

1

Gallbladder disease

a. Symptomatic

i. Treated by cholecystectomy

1

1

1

ii. Medically treated

1

1

1

iii. Current

1

1

1

b. Asymptomatic

1

1

1

History of cholestasis

a. Pregnancy-related

1

1

1

b. Past COC-related

1

1

1

Viral hepatitis

a. Acute or flare

1

1

1

b. Carrier

1

1

1

c. Chronic

1

1

1

Cirrhosis

a. Mild (compensated)

1

1

1

b. Severe§ (decompensated)

1

1

1

Liver tumors

a. Benign

i. Focal nodular hyperplasia

1

1

1

ii. Hepatocellular adenoma§

1

1

1

b. Malignant§ (hepatoma)

1

1

1

Anemias

Thalassemia

1

1

1

Sickle cell disease§

1

1

1

Iron deficiency anemia

1

1

1

Solid Organ Transplantation

Solid organ transplantation§

a. Complicated: graft failure (acute or chronic), rejection, cardiac allograft vasculopathy

1

1

1

b. Uncomplicated

1

1

1

TABLE. (Continued) Classifications for barrier methods,*† including condoms, spermicides, and diaphragms/caps

Condition

Category

Clarifications/Evidence/Comments

Condom

Spermicide

Diaphragm/cap

Drug Interactions

Antiretroviral (ARV) therapy

Clarification: No drug interaction between ARV therapy and barrier method use is known. However, HIV infection and AIDS are classified as Category 3 for spermicides and diaphragms (see HIV/AIDS condition above).

a. Nucleoside reverse transcriptase inhibitors (NRTIs)

1

3

3

b. Non-nucleoside reverse transcriptase inhibitors (NNRTIs)

1

3

3

c. Ritonavir-boosted protease inhibitors

1

3

3

Anticonvulsant therapy

a. Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine)

1

1

1

b. Lamotrigine

1

1

1

Antimicrobial therapy

a. Broad-spectrum antibiotics

1

1

1

b. Antifungals

1

1

1

c. Antiparasitics

1

1

1

d. Rifampicin or rifabutin therapy

1

1

1

Allergy to latex

3

1

3

Clarification: The condition of allergy to latex does not apply to plastic condoms/diaphragms.

* Abbreviations: STI = sexually transmitted infection; HIV = human immunodeficiency virus; BMI, body mass index; DVT = deep venous thrombosis; PE = pulmonary embolism; ARV = antiretroviral; hCG = human chorionic gonadotropin; PID = pelvic inflammatory disease; AIDS = acquired immunodeficiency syndrome; COC = combined oral contraceptive; NRTI = nucleoside reverse transcriptase inhibitor; NNRTI = non-nucleoside reverse transcriptase inhibitor.

† If risk exists for STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Consistent and correct use of the male latex condom reduces the risk for STIs and HIV transmission. Women with conditions that make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention may not be appropriate for those who cannot use them consistently and correctly because of the relatively higher typical-use failure rates of these methods.

§ Condition that exposes a woman to increased risk as a result of unintended pregnancy.

References

  1. The Criteria Committee of the New York Heart Association. Nomenclature and criteria for diagnosis of diseses of the heart and great vessels. 9th ed. Boston, MA: Little, Brown & Co; 1994.
  2. Wilkinson D, Ramjee G, Tholandi M, Rutherford G. Nonoxynol-9 for preventing vaginal acquisition of HIV infection by women from men. Cochrane Database Syst Rev 2002;4:CD003939.


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