| PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY |
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| PREGNANCY | NA | NA | NA | NA = not applicable
Clarification: Use of POCs is not required. There is no known harm to the woman, the course of her pregnancy, or the fetus if POCs are accidentally used during pregnancy. However, the relationship between DMPA use during pregnancy and its effects on the fetus remains unclear. |
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| AGE | | | | Evidence: Most studies have found that women lose bone mineral density while using DMPA, but regain bone mineral density after discontinuing DMPA. It is not known whether DMPA use among adolescents affects peak bone mass levels or whether adult women with long duration of DMPA use can regain bone mineral density to baseline levels before entering menopause. The relationship between DMPA-associated changes in bone mineral density during the reproductive years and future fracture risk is unknown.(1-41) Studies find no effect or have inconsistent results regarding the effects of POCs other than DMPA on bone mineral density.(42-54) |
| a) Menarche to < 18 years | 1 | 2 | 1 |
| b) 18 to 45 years | 1 | 1 | 1 |
| c) > 45 years | 1 | 2 | 1 |
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| PARITY | | | | |
| a) Nulliparous | 1 | 1 | 1 | |
| b) Parous | 1 | 1 | 1 | |
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| BREASTFEEDING | | | | Clarification: There is concern that the neonate may be at risk of exposure to steroid hormones during the first six weeks postpartum. However, in many settings pregnancy morbidity and mortality risks are high, and access to services is limited. In such settings, POCs may be one of the few types of methods widely available and accessible to breastfeeding women immediately postpartum.
Evidence: Direct evidence from clinical studies demonstrates no effect of POCs on breastfeeding performance (55-90) and generally demonstrates no harmful effects from exposure through breast milk in infants less than 6 weeks of age; however, these studies have been inadequately designed to determine whether a risk of either serious or subtle long-term effects exists.(55-59;67;69;71;73;80;83;84) Animal data suggest there is an effect of progesterone on the developing brain; whether similar effects occur following progestogen exposure in humans is unclear.(91-95) |
| a) < 6 weeks postpartum | 3 | 3 | 3 |
| b) ≥ 6 weeks to < 6 months postpartum (primarily breastfeeding) | 1 | 1 | 1 |
| c) ≥ 6 months postpartum | 1 | 1 | 1 |
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POSTPARTUM
(in non-breastfeeding women) | | | | |
| a) < 21 days | 1 | 1 | 1 | |
| b) ≥ 21 days | 1 | 1 | 1 | |
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| POST-ABORTION | | | | Clarification: POCs may be started immediately post-abortion.
Evidence: Limited evidence suggests that there are no adverse side effects when Norplant or NET-EN are initiated after first-trimester abortion.(96-99) |
| a) First trimester | 1 | 1 | 1 |
| b) Second trimester | 1 | 1 | 1 |
| c) Immediate post-septic abortion | 1 | 1 | 1 |
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| PAST ECTOPIC PREGNANCY* | 2 | 1 | 1 | |
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| HISTORY OF PELVIC SURGERY | 1 | 1 | 1 | |
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| SMOKING | | | | |
| a) Age < 35 years | 1 | 1 | 1 | |
| b) Age ≥ 35 years | | | | |
| (i) < 15 cigarettes/day | 1 | 1 | 1 | |
| ii) ≥ 15 cigarettes/day | 1 | 1 | 1 | |
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| OBESITY | | | | Clarification: There is no evidence of a differential weight gain among normal weight and obese adolescents who use NET-EN; this condition is classified as Category 1. However, the condition age < 18 years is classified as Category 2 due to evidence regarding potential effects of NET-EN on bone mineral density.
Evidence: Obese adolescents who used DMPA were more likely to gain weight than obese non-users, obese COC users, and non-obese DMPA users. This relationship was not observed among adult women. One small study did not observe increases in weight gain among adolescent Norplant users by any category of baseline weight.(100-108) |
| a) ≥ 30 kg/m2 BMI | 1 | 1 | 1 |
| b) Menarche to < 18 years and ≥ 30 kg/m2 BMI | 1 | DMPA=2
NET-EN=1 | 1 |
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| BLOOD PRESSURE MEASUREMENT UNAVAILABLE | NA | NA | NA | Clarification: It is desirable to have blood pressure measurements taken before initiation of POC use. However, in some settings blood pressure measurements are unavailable. In many of these settings pregnancy morbidity and mortality risks are high, and POCs are one of the few methods widely available. In such settings, women should not be denied use of POCs simply because their blood pressure cannot be measured. |
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| CARDIOVASCULAR DISEASE |
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MULTIPLE RISK FACTORS FOR ARTERIAL CARDIOVASCULAR DISEASE
(such as older age, smoking, diabetes and hypertension) | 2 | 3 | 2 | Clarification: When multiple major risk factors exist, the risk of cardiovascular disease may increase substantially. Some POCs may increase the risk of thrombosis, although this increase is substantially less than with COCs. The effects of DMPA and NET-EN may persist for some time after discontinuation. |
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HYPERTENSION*
For all categories of hypertension, classifications are based on the assumption that no other risk factors for cardiovascular disease exist. When multiple risk factors do exist, the risk of cardiovascular disease may increase substantially. A single reading of blood pressure level is not sufficient to classify a woman as hypertensive. |
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| a) History of hypertension, where blood pressure CANNOT be evaluated (including hypertension in pregnancy) | 2 | 2 | 2 | Clarification: It is desirable to have blood pressure measurements taken before initiation of POC use. However, in some settings blood pressure measurements are unavailable. In many of these settings pregnancy morbidity and morality risks are high, and POCs are one of the few types of methods widely available. In such settings, women should not be denied the use of POCs simply because their blood pressure cannot be measured. |
| b) Adequately controlled hypertension, where blood pressure CAN be evaluated | 1 | 2 | 1 | Clarification: Women adequately treated for hypertension are at reduced risk of acute myocardial infarction and stroke as compared with untreated women. Although there are no data, POC users with adequately controlled and monitored hypertension should be at reduced risk of acute myocardial infarction and stroke compared with untreated hypertensive POC users. |
| c) Elevated blood pressure levels (properly taken measurements) | | | | Evidence: Limited evidence suggests that among women with hypertension, those who used POPs or progestogen-only injectables had a small increased risk of cardiovascular events compared with women who did not use these methods.(109) |
| (i) systolic 140-159 or diastolic 90-99 mm Hg | 1 | 2 | 1 |
| (ii) systolic ≥160 or diastolic ≥100 mm Hg | 2 | 3 | 2 |
| d) Vascular disease | 2 | 3 | 2 | |
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HISTORY OF HIGH BLOOD PRESSURE DURING PREGNANCY
(where current blood pressure is measurable and normal) | 1 | 1 | 1 | |
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| DEEP VENOUS THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE)* | | | | |
| a) History of DVT/PE | 2 | 2 | 2 | |
| b) Acute DVT/PE | 3 | 3 | 3 | Evidence: There is no direct evidence on the use of POCs among women with DVT/PE on anticoagulant therapy. Although evidence on the risk of venous thrombosis with the use of POCs is inconsistent in otherwise healthy women, any small increased risk is substantially less than that with COCs.(109-111) |
| c) DVT/PE and established on anticoagulant therapy | 2 | 2 | 2 | Evidence: There is no direct evidence on the use of POCs among women with DVT/PE on anticoagulant therapy. Although evidence on the risk of venous thrombosis with the use of POCs is inconsistent in otherwise healthy women, any small increased risk is substantially less than that with COCs.(109-111) Limited evidence indicates that intramuscular injections of DMPA in women on chronic anticoagulation therapy does not pose a significant risk of hematoma at the injection site or increase the risk of heavy or irregular vaginal bleeding.(112;113) |
| d) Family history (first-degree relatives) | 1 | 1 | 1 | |
| e) Major surgery | | | | |
| (i) with prolonged immobilization | 2 | 2 | 2 | |
| (ii) without prolonged immobilization | 1 | 1 | 1 | |
| f) Minor surgery without immobilization | 1 | 1 | 1 | |
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KNOWN THROMBOGENIC MUTATIONS
(e.g., factor V Leiden; prothrombin mutation; protein S, protein C, and antithrombin deficiencies) | 2 | 2 | 2 | Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening. |
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| SUPERFICIAL VENOUS THROMBOSIS | | | | |
| a) Varicose veins | 1 | 1 | 1 | |
| b) Superficial thrombophlebitis | 1 | 1 | 1 | |
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| CURRENT AND HISTORY OF ISCHAEMIC HEART DISEASE* | I | C | | I | C | |
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| 2 | 3 | 3 | 2 | 3 | |
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STROKE*
(history of cerebrovascular accident) | I | C | | I | C | |
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| 2 | 3 | 3 | 2 | 3 | |
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| KNOWN HYPERLIPIDAEMIAS | 2 | 2 | 2 | Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening. Some types of hyperlipidaemias are risk factors for vascular disease. |
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| VALVULAR HEART DISEASE | | | | |
| a) Uncomplicated | 1 | 1 | 1 | |
| b) Complicated (pulmonary hypertension, risk of atrial fibrillation, history of subacute bacterial endocarditis) | 1 | 1 | 1 | |
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| RHEUMATIC DISEASES |
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SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)*
People with SLE are at increased risk of ischaemic heart disease, stroke and venous thromboembolism. Categories assigned to such conditions in the Medical eligibility criteria for contraceptive use should be the same for women with SLE who present with these conditions. For all categories of SLE, classifications are based on the assumption that no other risk factors for cardiovascular disease are present; these classifications must be modified in the presence of such risk factors. Available evidence indicates that many women with SLE can be considered good candidates for most contraceptive methods, including hormonal contraceptives.(114-132) |
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| a) Positive (or unknown) antiphospholipid antibodies | 3 | 3 | 3 | 3 | Evidence: Antiphospholipid antibodies are associated with a higher risk for both arterial and venous thrombosis.(133-135) |
| b) Severe thrombocytopenia | 2 | 3 | 2 | 2 | |
| c) Immunosuppressive treatment | 2 | 2 | 2 | 2 | |
| d) None of the above | 2 | 2 | 2 | 2 | |
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| NEUROLOGIC CONDITIONS |
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| HEADACHES* | I | C | I | C | I | C | |
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| a) Non-migrainous (mild or severe) | 1 | 1 | 1 | 1 | 1 | 1 | Clarification: Classification depends on accurate diagnosis of those severe headaches that are migrainous and those that are not. Any new headaches or marked changes in headaches should be evaluated. Classification is for women without any other risk factors for stroke. Risk of stroke increases with age, hypertension and smoking. |
| b) Migraine | | | | | | |
| (i) without aura | | | | | | |
| Age < 35 years | 1 | 2 | 2 | 2 | 2 | 2 |
| Age ≥ 35 years | 1 | 2 | 2 | 2 | 2 | 2 |
| (ii) with aura, at any age | 2 | 3 | 2 | 3 | 2 | 3 |
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| EPILEPSY | 1 | 1 | 1 | Clarification: If a woman is taking anticonvulsants, refer to the section on drug interactions. Certain anticonvulsants lower POC effectiveness. |
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| DEPRESSIVE DISORDERS |
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| DEPRESSIVE DISORDERS | 1 | 1 | 1 | Clarification: The classification is based on data for women with selected depressive disorders. No data on bipolar disorder or postpartum depression were available. There is a potential for drug interactions between certain antidepressant medications and hormonal contraceptives.
Evidence: POC use did not increase depressive symptoms in women with depression compared with baseline.(136-139) |
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| REPRODUCTIVE TRACT INFECTIONS AND DISORDERS |
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| VAGINAL BLEEDING PATTERNS* | | | | |
| a) Irregular pattern without heavy bleeding | 2 | 2 | 2 | |
| b) Heavy or prolonged bleeding (includes regular and irregular patterns) | 2 | 2 | 2 | Clarification: Unusually heavy bleeding should raise the suspicion of a serious underlying condition. |
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UNEXPLAINED VAGINAL BLEEDING*
(suspicious for serious condition)
Before evaluation | 2 | 3 | 3 | Clarification: If pregnancy or an underlying pathological condition (such as pelvic malignancy) is suspected, it must be evaluated and the category adjusted after evaluation. |
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| ENDOMETRIOSIS | 1 | 1 | 1 | |
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BENIGN OVARIAN TUMOURS
(including cysts) | 1 | 1 | 1 | |
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| SEVERE DYSMENORRHOEA | 1 | 1 | 1 | |
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| 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 | |
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| CERVICAL ECTROPION | 1 | 1 | 1 | |
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| CERVICAL INTRAEPITHELIAL NEOPLASIA (CIN) | 1 | 2 | 2 | Evidence: Among women with persistent HPV infection, long-term DMPA use (≥ 5 years) may increase the risk of carcinoma in situ and invasive carcinoma.(140) |
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CERVICAL CANCER*
(awaiting treatment) | 1 | 2 | 2 | |
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| BREAST DISEASE* | | | | |
| a) Undiagnosed mass | 2 | 2 | 2 | Clarification: Evaluation should be pursued as early as possible. |
| b) Benign breast disease | 1 | 1 | 1 | |
| c) Family history of cancer | 1 | 1 | 1 | |
| d) Breast cancer | | | | |
| (i) current | 4 | 4 | 4 | |
| (ii) past and no evidence of current disease for 5 years | 3 | 3 | 3 | |
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| ENDOMETRIAL CANCER* | 1 | 1 | 1 | |
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| OVARIAN CANCER* | 1 | 1 | 1 | |
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| UTERINE FIBROIDS* | | | | |
| a) Without distortion of the uterine cavity | 1 | 1 | 1 | |
| b) With distortion of the uterine cavity | 1 | 1 | 1 | |
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| PELVIC INFLAMMATORY DISEASE (PID)* | | | | |
| a) Past PID (assuming no current risk factors for STIs) | | | | |
| (i) with subsequent pregnancy | 1 | 1 | 1 | |
| (ii) without subsequent pregnancy | 1 | 1 | 1 | |
| b) PID - current | 1 | 1 | 1 | |
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| STIs | | | | |
| a) Current purulent cervicitis or chlamydial infection or gonorrhoea | 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 of STIs | 1 | 1 | 1 | Evidence: Evidence suggests that there may be an increased risk of chlamydial cervicitis among DMPA users at high risk of STIs. For other STIs, there is either evidence of no association between DMPA use and STI acquisition or too limited evidence to draw any conclusions. There is no evidence for other POCs.(141-148) |
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| HIV/AIDS |
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| HIGH RISK OF HIV | 1 | 1 | 1 | Evidence: The balance of the evidence suggests no association between POC use and HIV acquisition, although studies of DMPA use conducted among higher-risk populations have reported inconsistent findings.(149-173) |
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| HIV-INFECTED | 1 | 1 | 1 | Evidence: Most studies suggest no increased risk of HIV disease progression with hormonal contraceptive use, as measured by changes in CD4 cell count, viral load or survival. Studies observing that women with HIV who use hormonal contraception have increased risks of acquiring STIs are generally consistent with reports among uninfected women. One direct study found no association between hormonal contraceptive use and an increased risk of HIV transmission to uninfected partners; several indirect studies reported mixed results regarding whether hormonal contraception is associated with an increased risk of HIV-1 DNA or RNA shedding from the genital tract.(174-191) |
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| AIDS | 1 | 1 | 1 | Clarification: Because there may be drug interactions between hormonal contraceptives and ARV therapy, refer to the section on drug interactions. |
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| OTHER INFECTIONS |
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| SCHISTOSOMIASIS | | | | |
| a) Uncomplicated | 1 | 1 | 1 | Evidence: Among women with uncomplicated schistosomiasis, limited evidence showed that DMPA use had no adverse effects on liver function. (192) |
| b) Fibrosis of the liver (if severe, see cirrhosis) | 1 | 1 | 1 | |
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| TUBERCULOSIS | | | | Clarification: If a woman is taking rifampicin, refer to the section on drug interactions. Rifampicin is likely to decrease the effectiveness of some POCs. |
| a) Non-pelvic | 1 | 1 | 1 |
| a) Pelvic | 1 | 1 | 1 |
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| MALARIA | 1 | 1 | 1 | |
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| ENDOCRINE CONDITIONS |
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| DIABETES* | | | | |
| a) History of gestational disease | 1 | 1 | 1 | Evidence: POCs had no adverse effects on serum lipid levels in women with a history of gestational diabetes in two small studies.(193;194) Limited evidence is inconsistent regarding the development of non-insulin-dependent diabetes among users of POCs with a history of gestational diabetes. (195-198) |
| b) Non-vascular disease | | | | Evidence: Among women with insulin or non-insulin dependent diabetes, limited evidence on the use of progestogen-only methods (POPs, DMPA, LNG implant) suggests that these methods have little effect on short-term or long-term diabetes control (e.g., HbA1c levels), haemostatic markers or lipid profile.(199-202) |
| (i) non-insulin dependent | 2 | 2 | 2 |
| (ii) insulin dependent | 2 | 2 | 2 |
| c) Nephropathy/retinopathy/neuropathy | 2 | 3 | 2 | |
| d) Other vascular disease or diabetes of > 20 years' duration | 2 | 3 | 2 | |
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| THYROID DISORDERS | | | | |
| a) Simple goitre | 1 | 1 | 1 | |
| b) Hyperthyroid | 1 | 1 | 1 | |
| c) Hypothyroid | 1 | 1 | 1 | |
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| GASTROINTESTINAL CONDITIONS |
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| GALL BLADDER DISEASE | | | | |
| a) Symptomatic | | | | |
| (i) treated by cholecystectomy | 2 | 2 | 2 | |
| (ii) medically treated | 2 | 2 | 2 | |
| (iii) current | 2 | 2 | 2 | |
| b) Asymptomatic | 2 | 2 | 2 | |
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| HISTORY OF CHOLESTASIS* | | | | |
| a) Pregnancy-related | 1 | 1 | 1 | |
| b) Past-COC related | 2 | 2 | 2 | |
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| VIRAL HEPATITIS | | | | |
| a) Acute or flare | 1 | 1 | 1 | |
| b) Carrier | 1 | 1 | 1 | |
| c) Chronic | 1 | 1 | 1 | |
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| CIRRHOSIS | | | | |
| a) Mild (compensated) | 1 | 1 | 1 | |
| b) Severe (decompensated) | 3 | 3 | 3 | |
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| LIVER TUMOURS* | | | | |
| a) Benign | | | | |
| (i) Focal nodular hyperplasia | 2 | 2 | 2 | Evidence: There is limited, direct evidence that hormonal contraceptive use does not influence either progression or regression of liver lesions among women with focal nodular hyperplasia. (203-205) |
| (ii) Hepatocellular adenoma | 3 | 3 | 3 | |
| b) Malignant (hepatoma) | 3 | 3 | 3 | |
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| ANAEMIAS |
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| THALASSAEMIA | 1 | 1 | 1 | |
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| SICKLE CELL DISEASE | 1 | 1 | 1 | Evidence: Among women with sickle cell disease, POC use did not have adverse effects on haematological parameters and, in some studies, was beneficial with respect to clinical symptoms. (206-213) |
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| IRON-DEFICIENCY ANAEMIA* | 1 | 1 | 1 | |
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| DRUG INTERACTIONS |
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| ANTIRETROVIRAL THERAPY | | | | Clarification: Antiretroviral drugs have the potential to either decrease or increase the bioavailability of steroid hormones in hormonal contraceptives. Limited data (summarized in Annex 1) suggest potential drug interactions between many antiretroviral drugs (particularly some NNRTIs and ritonavir-boosted protease inhibitors) and hormonal contraceptives. These interactions may alter the safety and effectiveness of both the hormonal contraceptive and the antiretroviral drug. Thus, if a woman on antiretroviral treatment decides to initiate or continue hormonal contraceptive use, the consistent use of condoms is recommended. This is both for preventing HIV transmission and to compensate for any possible reduction in the effectiveness of the hormonal contraceptive. |
| a) Nucleoside reverse transcriptase inhibitors (NRTIs) | 1 | DMPA=1
NET-EN=1 | 1 |
| b) Non-nucleoside reverse transcriptase inhibitors (NNRTIs) | 2 | DMPA=1
NET-EN=2 | 2 |
| c) Ritonavir-boosted protease inhibitors | 3 | DMPA=1
NET-EN=2 | 2 |
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| ANTICONVULSANT THERAPY | | | | |
| a) Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine) | 3 | DMPA=1
NET-EN=2 | 2 | Clarification: Although the interaction of certain anticonvulsants with POPs, NET-EN and LNG/ETG implants is not harmful to women, it is likely to reduce the effectiveness of POPs, NET-EN and LNG/ETG implants. Whether increasing the hormone dose of POPs alleviates this concern remains unclear. Use of other contraceptives should be encouraged for women who are long-term users of any of these drugs. Use of DMPA is Category 1 because its effectiveness is not decreased by the use of certain anticonvulsants.
Evidence: Use of certain anticonvulsants may decrease the effectiveness of POCs.(214-216) |
| b) Lamotrigine | 1 | 1 | 1 | Evidence: No drug interactions have been reported among women with epilepsy taking lamotrigine and using POCs.(217) |
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| ANTIMICROBIAL THERAPY | | | | |
| a) Broad-spectrum antibiotics | 1 | 1 | 1 | |
| b) Antifungals | 1 | 1 | 1 | |
| c) Antiparasitics | 1 | 1 | 1 | |
| d) Rifampicin or rifabutin therapy | 3 | DMPA=1
NET-EN=2 | 2 | Clarification: Although the interaction of rifampicin or rifabutin with POPs, NET-EN and LNG/ETG implants is not harmful to women, it is likely to reduce the effectiveness of POPs, NET-EN and LNG/ ETG implants. Use of other contraceptives should be encouraged for women who are long-term users of any of these drugs. Use of DMPA is Category 1 because its effectiveness is not decreased by the use of rifampicin or rifabutin. Whether increasing the hormone dose of POPs alleviates this concern remains unclear. |
