TABLE E1. Classifications for barrier methods, including condoms, spermicide and vaginal pH modulator, and diaphragm with spermicide and cervical cap with spermicide.
| Condition | Category |
Clarification/Evidence/Comment | ||
|---|---|---|---|---|
| Condom | Spermicide/Vaginal pH modulator | Diaphragm/Cap (with spermicide) | ||
|
Personal
Characteristics and Reproductive History
| ||||
|
Pregnancy
|
NA |
NA |
NA |
Clarification: None of
these methods are relevant for contraception during known
pregnancy. However, for persons who remain at risk for STIs or
HIV infection during pregnancy, the correct and consistent use
of condoms is recommended. |
|
Age
| ||||
| a. Menarche to <40
years |
1 |
1 |
1 |
— |
| b. ≥40
years |
1 |
1 |
1 |
— |
|
Parity
| ||||
| a. Nulliparous |
1 |
1 |
1 |
— |
| b. Parous |
1 |
1 |
2 |
Clarification: Risk for
cervical cap failure is higher in parous persons than in
nulliparous persons. |
|
Postpartum (breastfeeding
and
nonbreastfeeding) | ||||
| a. <6 weeks
postpartum |
1 |
1 |
NA |
Clarification: Diaphragm
and cap are unsuitable until uterine involution is
complete. |
| b. ≥6 weeks
postpartum |
1 |
1 |
1 |
— |
|
Postabortion (spontaneous
or
induced) | ||||
| a. First trimester
abortion |
1 |
1 |
1 |
— |
| b. Second trimester
abortion |
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
years |
1 |
1 |
1 |
— |
| b. Age
≥35 years | ||||
| i. <15
cigarettes per day |
1 |
1 |
1 |
— |
| ii.
≥15 cigarettes per day |
1 |
1 |
1 |
— |
|
Obesity
| ||||
| a. BMI ≥30
kg/m2 |
1 |
1 |
1 |
— |
| b. Menarche to <18
years 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 3). | ||||
| a. Restrictive procedures:
decrease storage capacity of the stomach (vertical banded
gastroplasty, laparoscopic adjustable gastric band, or
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 or biliopancreatic
diversion) |
1 |
1 |
1 |
— |
|
Surgery
| ||||
| a. Minor surgery without
immobilization |
1 |
1 |
1 |
— |
| b. Major
surgery | ||||
| i.
Without prolonged immobilization |
1 |
1 |
1 |
— |
| ii. With prolonged
immobilization |
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 3). | ||||
| 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 This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). | ||||
| a. Current or history of
DVT/PE, receiving anticoagulant therapy (therapeutic dose)
(e.g., acute DVT/PE or long-term therapeutic dose) |
1 |
1 |
1 |
— |
| b. History of
DVT/PE, receiving
anticoagulant
therapy
(prophylactic dose) | ||||
| i. Higher
risk for recurrent DVT/PE (one or more risk factors) |
1 |
1 |
1 |
— |
| • Thrombophilia
(e.g., factor V Leiden mutation; prothrombin gene mutation;
protein S, protein C, and antithrombin deficiencies; or
antiphospholipid
syndrome) • Active cancer (metastatic, receiving therapy, or within 6 months after clinical remission), excluding nonmelanoma skin cancer • History of recurrent DVT/PE | ||||
| ii. Lower
risk for recurrent DVT/PE (no risk factors) |
1 |
1 |
1 |
— |
| c. History of
DVT/PE, not receiving
anticoagulant therapy | ||||
| i. Higher
risk for recurrent DVT/PE (one or more risk factors) |
1 |
1 |
1 |
— |
| • History of
estrogen-associated
DVT/PE • Pregnancy-associated DVT/PE • Idiopathic DVT/PE • Thrombophilia (e.g., factor V Leiden mutation; prothrombin gene mutation; protein S, protein C, and antithrombin deficiencies; or antiphospholipid syndrome) • Active cancer (metastatic, receiving therapy, or within 6 months after clinical remission), excluding nonmelanoma skin cancer • History of recurrent DVT/PE | ||||
| ii. Lower
risk for recurrent DVT/PE (no risk factors) |
1 |
1 |
1 |
— |
| d. Family history
(first-degree relatives) |
1 |
1 |
1 |
— |
|
Thrombophilia
(e.g., factor V Leiden mutation; prothrombin gene mutation;
protein S, protein C, and antithrombin deficiencies; or
antiphospholipid syndrome) This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). |
1 |
1 |
1 |
Clarification: Routine
screening in the general population before contraceptive
initiation is not recommended. |
|
Superficial venous disorders
| ||||
| a. Varicose
veins |
1 |
1 |
1 |
— |
| b. Superficial venous
thrombosis (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 3). |
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 3). |
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 3). | ||||
| 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 3). | ||||
| a. Normal or mildly impaired cardiac function (New York Heart Association Functional Class I or II: no limitation of activities or slight, mild limitation of activity) (3) | ||||
| i. <6
months |
1 |
1 |
1 |
— |
| ii.
≥6 months |
1 |
1 |
1 |
— |
| b. Moderately or severely
impaired cardiac function (New York Heart Association Functional
Class III or IV: marked limitation of activity or should be at
complete rest) (3) |
1 |
1 |
1 |
— |
|
Renal
Disease
| ||||
|
Chronic
kidney disease This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). | ||||
| a. Current nephrotic
syndrome |
1 |
1 |
1 |
— |
| b. Hemodialysis |
1 |
1 |
1 |
— |
| c. Peritoneal
dialysis |
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 3). | ||||
| 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. Not receiving
immunosuppressive therapy |
1 |
1 |
1 |
— |
| b. Receiving
immunosuppressive therapy |
1 |
1 |
1 |
— |
|
Neurologic Conditions
| ||||
|
Headaches
| ||||
| a. Nonmigraine (mild or
severe) |
1 |
1 |
1 |
— |
| b.
Migraine | ||||
| i. Without
aura (includes menstrual migraine) |
1 |
1 |
1 |
Comment: Menstrual
migraine is a subtype of migraine without aura. For more
information see the International Headache Society’s
International Classification of Headache Disorders,
3rd ed. (https://ichd-3.org) (4). |
| ii. With
aura |
1 |
1 |
1 |
— |
|
Epilepsy This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). |
1 |
1 |
1 |
— |
|
Multiple
sclerosis
| ||||
| a. Without prolonged
immobility |
1 |
1 |
1 |
— |
| b. With 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 3). | ||||
| 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 or 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 |
Vaginal pH modulator:
1 Spermicide: 2 |
1 |
Clarification: The cap
should not be used. Diaphragm use has no
restrictions. Comment: Repeated and high-dose use of the spermicide nonoxynol-9 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 3). | ||||
| 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 3). |
1 |
1 |
1 |
— |
|
Ovarian
cancer This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). |
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 person with markedly distorted cervical
anatomy. |
|
Pelvic
inflammatory disease
| ||||
| a. Current PID |
1 |
1 |
1 |
— |
| b. Past
PID | ||||
| i. With
subsequent pregnancy |
1 |
1 |
1 |
— |
| ii.
Without subsequent pregnancy |
1 |
1 |
1 |
— |
|
Sexually
transmitted infections
| ||||
| 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 STIs |
1 |
1 |
1 |
— |
|
HIV
| ||||
|
High risk for HIV
infection
|
1 |
Vaginal pH modulator:
1 Spermicide: 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 (5). Comment: Diaphragm and cap use is assigned category 4 because of concerns about the spermicide, not the diaphragm or cap. |
|
HIV
infection For persons 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 3). |
1 |
Vaginal pH modulator:
1 Spermicide: 3 |
3 |
Comment: Use of
spermicides, including with diaphragms and caps, 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
3). | ||||
| a. Uncomplicated |
1 |
1 |
1 |
— |
| b. Fibrosis of the
liver |
1 |
1 |
1 |
— |
|
Tuberculosis This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). | ||||
| 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 |
Vaginal pH modulator:
2 Spermicide: 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 3). | ||||
| 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 years' 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. Asymptomatic |
1 |
1 |
1 |
— |
| b. Symptomatic |
|
|
|
|
| i.
Current |
1 |
1 |
1 |
— |
| ii.
Treated by cholecystectomy |
1 |
1 |
1 |
— |
| iii.
Medically treated |
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. Chronic |
1 |
1 |
1 |
— |
|
Cirrhosis Decompensated cirrhosis is associated with increased risk for adverse health events as a result of pregnancy (Box 3). | ||||
| a. Compensated (normal
liver function) |
1 |
1 |
1 |
— |
| b. Decompensated (impaired
liver function) |
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 3). | ||||
| a.
Benign | ||||
| i.
Focal nodular hyperplasia |
1 |
1 |
1 |
— |
| ii. Hepatocellular adenoma |
1 |
1 |
1 |
— |
| b. Malignant
(hepatocellular carcinoma) |
1 |
1 |
1 |
— |
|
Respiratory Conditions
| ||||
|
Cystic
fibrosis This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). |
1 |
1 |
1 |
— |
|
Hematologic Conditions
| ||||
|
Thalassemia
|
1 |
1 |
1 |
— |
|
Sickle cell
disease This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 3). |
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 3). | ||||
| a. No graft
failure |
1 |
1 |
1 |
— |
| b. Graft failure |
1 |
1 |
1 |
— |
|
Drug
Interactions
| ||||
|
Antiretrovirals used for
prevention (PrEP) or
treatment
of HIV infection
|
Clarification: No drug interaction between ARV
therapy and barrier method use is known. HIV infection is
classified as category 1 for vaginal pH modulator and category 3
for spermicide and diaphragm and cap use (see recommendations
for HIV infection). High risk for HIV infection is classified as
category 1 for vaginal pH modulator and category 4 for
spermicide and diaphragm or cap (see recommendations for High
risk for HIV infection). |
|||
| a. Nucleoside
reverse
transcriptase inhibitors (NRTIs) | ||||
| i.
Abacavir (ABC) |
1 |
1/3/4 |
3/4 |
|
| ii.
Tenofovir (TDF) |
1 |
1/3/4 |
3/4 |
|
| iii.
Zidovudine (AZT) |
1 |
1/3/4 |
3/4 |
|
| iv.
Lamivudine (3TC) |
1 |
1/3/4 |
3/4 |
|
| v.
Didanosine (DDI) |
1 |
1/3/4 |
3/4 |
|
| vi.
Emtricitabine (FTC) |
1 |
1/3/4 |
3/4 |
|
| vii.
Stavudine (D4T) |
1 |
1/3/4 |
3/4 |
|
| b.
Nonnucleoside reverse
transcriptase inhibitors
(NNRTIs) | ||||
| i.
Efavirenz (EFV) |
1 |
1/3/4 |
3/4 |
|
| ii.
Etravirine (ETR) |
1 |
1/3/4 |
3/4 |
|
| iii.
Nevirapine (NVP) |
1 |
1/3/4 |
3/4 |
|
| iv.
Rilpivirine (RPV) |
1 |
1/3/4 |
3/4 |
|
| c.
Ritonavir-boosted protease
inhibitors | ||||
| i.
Ritonavir-boosted atazanavir (ATV/r) |
1 |
1/3/4 |
3/4 |
|
| ii.
Ritonavir-boosted darunavir (DRV/r) |
1 |
1/3/4 |
3/4 |
|
| iii.
Ritonavir-boosted fosamprenavir (FPV/r) |
1 |
1/3/4 |
3/4 |
|
| iv.
Ritonavir-boosted lopinavir (LPV/r) |
1 |
1/3/4 |
3/4 |
|
| v.
Ritonavir-boosted saquinavir (SQV/r) |
1 |
1/3/4 |
3/4 |
|
| vi.
Ritonavir-boosted tipranavir (TPV/r) |
1 |
1/3/4 |
3/4 |
|
| d. Protease
inhibitors without ritonavir | ||||
| i.
Atazanavir (ATV) |
1 |
1/3/4 |
3/4 |
|
| ii.
Fosamprenavir (FPV) |
1 |
1/3/4 |
3/4 |
|
| iii.
Indinavir (IDV) |
1 |
1/3/4 |
3/4 |
|
| iv.
Nelfinavir (NFV) |
1 |
1/3/4 |
3/4 |
|
| e. CCR5
co-receptor antagonists | ||||
| i.
Maraviroc (MVC) |
1 |
1/3/4 |
3/4 |
|
| f. HIV
integrase strand transfer
inhibitors | ||||
| i.
Raltegravir (RAL) |
1 |
1/3/4 |
3/4 |
|
| ii.
Dolutegravir (DTG) |
1 |
1/3/4 |
3/4 |
|
| iii.
Elvitegravir (EVG) |
1 |
1/3/4 |
3/4 |
|
| g. Fusion
inhibitors | ||||
| i.
Enfuvirtide |
1 |
1/3/4 |
3/4 |
|
|
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. Selective serotonin
reuptake inhibitors (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 or diaphragms. |
Abbreviations: ARV = antiretroviral; BMI = body mass index; COC = combined oral contraceptive; DVT = deep venous thrombosis; hCG = human chorionic gonadotropin; HDL = high-density lipoprotein; LDL = low-density lipoprotein; NA = not applicable; PE = pulmonary embolism; PID = pelvic inflammatory disease; PrEP = pre-exposure prophylaxis; STI = sexually transmitted infection.