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 E1) (Table E1).

Women with conditions that make pregnancy an unacceptable risk should be advised that barrier methods for pregnancy prevention might not be appropriate for those who cannot use them consistently and correctly because of the relatively higher typical-use failure rates of these methods. Women should be counseled that consistent and correct use of the male latex condom reduces the risk for transmission of human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs). Use of female condoms can provide protection from transmission of STDs, although data are limited.

BOX E1. 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 E1. Classifications for barrier methods, including condoms, spermicides, diaphragms (with spermicide), and cap
Condition Category Clarifications/Evidence/Comments
Condom Spermicide Diaphragm (with spermicide)/Cap
Personal Characteristics and Reproductive History
PregnancyNot applicableNot applicableNot applicableClarification: None of these methods are relevant for contraception during known pregnancy. However, for women who remain at risk for STDs/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 (breastfeeding and nonbreastfeeding)
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. BMI ≥30 kg/m2 1 1 1
b. Menarche to <18 yrs and BMI ≥30 kg/m2 1 1 1
History of bariatric surgery
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Restrictive procedures: decrease storage capacity of the stomach (vertical banded gastroplasty, laparoscopic adjustable gastric band, laparoscopic sleeve gastrectomy) 1 1 1
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 atherosclerotic cardiovascular disease (e.g., older age, smoking, diabetes, hypertension, low HDL, high LDL, or high triglyceride levels) 1 1 1
Hypertension
Systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg are associated with increased risk for adverse health events as a result of pregnancy (Box 2).
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 (when current blood pressure is measurable and normal) 1 1 1
Deep venous thrombosis/ Pulmonary embolism
a. History of DVT/PE, not receiving anticoagulant therapy
i. Higher risk for recurrent DVT/PE (one or more risk factors)

• History of estrogen-associated DVT/PE

• Pregnancy-associated DVT/PE

• Idiopathic DVT/PE

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, receiving 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 months
i. Higher risk for recurrent DVT/PE (one or more risk factors)

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, receiving 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; or protein S, protein C, and antithrombin deficiencies)
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1 Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening.
Superficial venous disorders
a. Varicose veins 1 1 1
b. Superficial thrombophlebitis (acute or history) 1 1 1
Current and history of ischemic heart disease
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1
Stroke (history of cerebrovascular accident)
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1
Valvular heart disease

Complicated valvular heart disease is associated with increased risk for adverse health events as a result of pregnancy (Box 2).

a. Uncomplicated 1 1 1
b. Complicated (pulmonary hypertension, risk for atrial fibrillation, or history of subacute bacterial endocarditis) 1 1 2
Peripartum cardiomyopathy
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
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
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Positive (or unknown) antiphospholipid antibodies 1 1 1
b. Severe thrombocytopenia 1 1 1
c. Immunosuppressive therapy 1 1 1
d. None of the above 1 1 1
Rheumatoid arthritis
a. Receiving immunosuppressive therapy 1 1 1
b. Not receiving immunosuppressive therapy 1 1 1
Neurologic Conditions
Headaches
a. Nonmigraine (mild or severe) 1 1 1
b. Migraine
i. Without aura (This category of migraine includes menstrual migraine.) 1 1 1 Comment: Menstrual migraine is a subtype of migraine without aura. For more information see The International Headache Society Classification, 3rd edition (http://www.ihs-classification.org/_downloads/mixed/International-Headache-Classification-III-ICHD-III-2013-Beta.pdfCdc-pdfExternal).
ii. With aura 1 1 1
Epilepsy
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1
Multiple sclerosis
a. With prolonged immobility 1 1 1
b. Without prolonged immobility 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 (e.g., 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
Gestational trophoblastic disease
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Suspected gestational trophoblastic disease (immediate postevacuation)
i. Uterine size first trimester 1 1 1
ii. Uterine size second trimester 1 1 1
b. Confirmed gestational trophoblastic disease (after initial evacuation and during monitoring)
i. Undetectable/nonpregnant β–hCG levels 1 1 1
ii. Decreasing β–hCG levels 1 1 1
iii. Persistently elevated β-hCG levels or malignant disease, with no evidence or suspicion of intrauterine disease 1 1 1
iv.Persistently elevated β-hCG levels or malignant disease, with evidence or suspicion of intrauterine 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 the spermicide can cause vaginal and cervical irritation or abrasions.

Breast disease
Breast cancer is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
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 years 1 1 1
Endometrial hyperplasia 1 1 1
Endometrial cancer
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1
Ovarian cancer
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1
Uterine fibroids 1 1 1
Anatomical abnormalities 1 1 NA 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
i. With subsequent pregnancy 1 1 1
ii. Without subsequent pregnancy 1 1 1
b. Current PID 1 1 1
Sexually transmitted diseases
a. Current purulent cervicitis or chlamydial infection or gonococcal infection 1 1 1
b. Vaginitis (including Trichomonas vaginalis and bacterial vaginosis) 1 1 1
c. Other factors related to STDs 1 1 1
HIV
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
For women with HIV infection who are not clinically well or not receiving ARV therapy, this condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 3 3 Comment: Use of spermicides or diaphragms (with spermicide) can disrupt the cervical mucosa, which might increase viral shedding and HIV transmission to noninfected sex partners.
Other Infections
Schistosomiasis
Schistosomiasis with fibrosis of the liver is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Uncomplicated 1 1 1
b. Fibrosis of liver 1 1 1
Tuberculosis
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Nonpelvic 1 1 1
b. Pelvic 1 1 1
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
Insulin-dependent diabetes; diabetes with nephropathy, retinopathy, or neuropathy; diabetes with other vascular disease; or diabetes of >20 years’ duration are associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. History of gestational disease 1 1 1
b. Nonvascular disease
i. Non-insulin dependent 1 1 1
ii. Insulin dependent 1 1 1
c. Nephropathy, retinopathy, or 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, or Crohn’s 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
Severe cirrhosis is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Mild (compensated) 1 1 1
b. Severe (decompensated) 1 1 1
Liver tumors
Hepatocellular adenoma and malignant liver tumors are associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Benign
i. Focal nodular hyperplasia 1 1 1
ii. Hepatocellular adenoma 1 1 1
b. Malignant (hepatoma) 1 1 1
Respiratory Conditions
Cystic fibrosis
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1
Anemias
Thalassemia 1 1 1
Sickle cell disease
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
1 1 1
Iron deficiency anemia 1 1 1
Solid Organ Transplantation
Solid organ transplantation
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).
a. Complicated: graft failure (acute or chronic), rejection, or cardiac allograft vasculopathy 1 1 1
b. Uncomplicated 1 1 1
Drug Interactions
Antiretroviral therapy Clarification: No drug interaction between ARV therapy and barrier method use is known. However, HIV infection is classified as category 3 for spermicides and diaphragms (see HIV section).
a. Nucleoside reverse transcriptase inhibitors (NRTIs)
i. Abacavir (ABC) 1 3 3
ii. Tenofovir (TDF) 1 3 3
iii. Zidovudine (AZT) 1 3 3
iv. Lamivudine (3TC) 1 3 3
v. Didanosine (DDI) 1 3 3
vi. Emtricitabine (FTC) 1 3 3
vii. Stavudine (D4T) 1 3 3
b. Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
i. Efavirenz (EFV) 1 3 3
ii. Etravirine (ETR) 1 3 3
iii. Nevirapine (NVP) 1 3 3
iv. Rilpivirine (RPV) 1 3 3
c. Ritonavir-boosted protease inhibitors
i. Ritonavir-boosted atazanavir (ATV/r) 1 3 3
ii. Ritonavir-boosted darunavir (DRV/r) 1 3 3
iii. Ritonavir-boosted fosamprenavir (FPV/r) 1 3 3
iv. Ritonavir-boosted lopinavir (LPV/r) 1 3 3
v. Ritonavir-boosted saquinavir (SQV/r) 1 3 3
vi. Ritonavir-boosted tipranavir (TPV/r) 1 3 3
d. Protease inhibitors without ritonavir
i. Atazanavir (ATV) 1 3 3
ii. Fosamprenavir (FPV) 1 3 3
iii. Indinavir (IDV) 1 3 3
iv. Nelfinavir (NFV) 1 3 3
e. CCR5 co-receptor antagonists
i. Maraviroc (MVC) 1 3 3
f. HIV integrase strand transfer inhibitors
i. Raltegravir (RAL) 1 3 3
ii. Dolutegravir (DTG) 1 3 3
iii. Elvitegravir (EVG) 1 3 3
g. Fusion inhibitors
i. Enfuvirtide 1 3 3
Anticonvulsant therapy
a. Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, or 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. Rifampin or rifabutin therapy 1 1 1
Psychotropic medications
a. SSRIs 1 1 1
St. John’s wort 1 1 1
Allergy to latex 3 1 3 Clarification: The condition of allergy to latex does not apply to plastic condoms/diaphragms.
* Abbreviations: ARV = antiretroviral; BMI = body mass index; COC = combined oral contraceptive; DVT = deep venous thrombosis; hCG = human chorionic gonadotropin; HDL = high-density lipoprotein; HIV = human immunodeficiency virus; LDL = low-density lipoprotein; NA = not applicable; PE = pulmonary embolism; PID = pelvic inflammatory disease; SSRI = selective serotonin reuptake inhibitor; STD = sexually transmitted disease.

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.