[Table, Intrauterine devices (IUDs)]. - Medical Eligibility Criteria for Contraceptive Use

INTRAUTERINE DEVICES (IUDs)

IUDs do not protect against sexually transmitted infections (STIs), including HIV. If there is a risk of STI/HIV, the correct and consistent use of condoms is recommended. When used correctly and consistently, condoms offer one of the most effective methods of protection against STIs, including HIV. Female condoms are effective and safe, but are not used as widely by national programmes as male condoms.

CONDITION	CATEGORY I = initiation, C = continuation				CLARIFICATIONS/EVIDENCE

	Cu-IUD		LNG-IUD

^† recommendations reviewed for the MEC 5th edition, further details after this table * additional comments after this table	Cu-IUD = copper-bearing IUD LNG-IUD = levonorgestrel-releasing IUD (20 µg/24 hours)
PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY

PREGNANCY	4		4		Clarification: The IUD is not indicated during pregnancy and should not be used because of the risk of serious pelvic infection and septic spontaneous abortion.

AGE					Evidence: Risks of pregnancy, infection and perforation are low among IUD users of any age. Heavy bleeding or removals for bleeding do not seem to be associated with age. Young women using Cu-IUDs may have an increased risk of expulsion compared with older Cu-IUD users (1–15).
a) Menarche to < 20 years	2		2
b) ≥ 20 years	1		1

PARITY					Evidence: Risks of pregnancy, infection, perforation and expulsion are low among all IUD users, and differences by parity may not be clinically meaningful. Data do not suggest an increased delay in return to fertility for nulliparous IUD users (1, 3, 7–10).
a) Nulliparous	2		2
b) Parous	1		1

POSTPARTUM ^† (breastfeeding or non-breastfeeding women, including caesarean section)
a) < 48 hours including insertion immediately after delivery of the placenta					Evidence: Immediate postpartum Cu-IUD insertion, particularly when insertion occurs immediately after delivery of the placenta, is associated with lower expulsion rates than delayed postpartum insertion. Additionally, post-placental placement at the time of caesarean section has lower expulsion rates than post-placental vaginal insertions. Insertion complications of perforation and infection are not increased by IUD placement at any time during the postpartum period (16–29). One randomized controlled trial found that immediate insertion of the LNG-IUD was associated with decreased breastfeeding duration compared with delayed insertion (30). Two other randomized controlled trials assessing early vs delayed initiation of progestogen-only contraceptives failed to show a difference in breastfeeding outcomes (31, 32). In other studies, initiation of LNG-IUD at 4 weeks postpartum or later demonstrated no detrimental effect on breastfeeding outcomes (33–35).
i) breastfeeding	1		2
ii) non-breastfeeding	1		1
b) ≥ 48 hours to < 4 weeks	3		3
c) ≥ 4 weeks	1		1
d) Puerperal sepsis	4		4

POST-ABORTION*
a) First trimester	1		1		Clarification: IUDs can be inserted immediately after first-trimester, spontaneous or induced abortion. Evidence: There was no difference in risk of complications for immediate vs delayed insertion of an IUD after abortion. Expulsion was greater when an IUD was inserted following a second-trimester abortion vs a first-trimester abortion. There were no differences in safety or expulsions for post-abortion insertion of an LNG-IUD compared with a Cu-IUD (36–48).
b) Second trimester	2		2
c) Immediate post-septic abortion	4		4

PAST ECTOPIC PREGNANCY*	1		1

HISTORY OF PELVIC SURGERY (see postpartum, including caesarean section)	1		1

SMOKING
a) Age < 35 years	1		1
b) Age ≥ 35 years
i) < 15 cigarettes/day	1		1
ii) ≥ 15 cigarettes/day	1		1

OBESITY
a) ≥ 30 kg/m² BMI	1		1
b) Menarche to < 18 years and ≥ 30 kg/m² BMI	1		1

BLOOD PRESSURE MEASUREMENT UNAVAILABLE	NA		NA		NA = not applicable Clarification: While a blood pressure measurement may be appropriate for good preventive health care, it is not materially related to safe and effective IUD use. Women should not be denied use of IUDs simply because their blood pressure cannot be measured.

CARDIOVASCULAR DISEASE

MULTIPLE RISK FACTORS FOR ARTERIAL CARDIOVASCULAR DISEASE (such as older age, smoking, diabetes, hypertension and known dyslipidaemias)	1		2

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.

a) History of hypertension, where blood pressure CANNOT be evaluated (including hypertension in pregnancy)	1		2
b) Adequately controlled hypertension, where blood pressure CAN be evaluated	1		1
c) Elevated blood pressure levels (properly taken measurements)
i) systolic 140–159 or diastolic 90–99 mm Hg	1		1
ii) systolic ≥ 160 or diastolic ≥ 100 mm Hg	1		2
d) Vascular disease	1		2

HISTORY OF HIGH BLOOD PRESSURE DURING PREGNANCY (where current blood pressure is measurable and normal)	1		1

DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE)*
a) History of DVT/PE	1		2
b) Acute DVT/PE	1		3		Evidence: Although evidence on the risk of venous thrombosis with the use of progestogen-only contraceptives (POCs) is inconsistent, any small increased risk is substantially less than that with combined oral contraceptives (COCs) (49–51).
c) DVT/PE and established on anticoagulant therapy	1		2		Evidence: Although evidence on the risk of venous thrombosis with the use of POCs is inconsistent, any small increased risk is substantially less than that with COCs (49–51). Limited evidence indicates that insertion of the LNG-IUD does not pose major bleeding risks in women on chronic anticoagulant therapy (52–54).
d) Family history (first-degree relatives)	1		1
e) Major surgery
i) with prolonged immobilization	1		2
ii) without prolonged immobilization	1		1
f) Minor surgery without immobilization	1		1

KNOWN THROMBOGENIC MUTATIONS (e.g. factor V Leiden; prothrombin mutation; protein S, protein C, and antithrombin deficiencies)	1		2		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
b) Superficial venous thrombosis	1		1

CURRENT AND HISTORY OF ISCHAEMIC HEART DISEASE*	1		I	C

			2	3

STROKE* (history of cerebrovascular accident)	1		2

KNOWN DYSLIPIDAEMIAS WITHOUT OTHER KNOWN CARDIOVASCULAR RISK FACTORS	1		2		Clarification: Routine screening is not appropriate because of the rarity of the condition and the high cost of screening.

VALVULAR HEART DISEASE
a) Uncomplicated	1		1
b) Complicated (pulmonary hypertension, risk of atrial fibrillation, history of subacute bacterial endocarditis)	2		2		Clarification: Prophylactic antibiotics to prevent endocarditis are advised for insertion.

RHEUMATIC DISEASES

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 (54–71).

a) Positive (or unknown) antiphospholipid antibodies	I	C			Evidence: Antiphospholipid antibodies are associated with a higher risk for both arterial and venous thrombosis (72, 73).

	1	1	3
b) Severe thrombocytopenia	3	2	2		Clarification: Severe thrombocytopenia increases the risk of bleeding. The category should be assessed according to the severity of the thrombocytopenia and its clinical manifestations. In women with very severe thrombocytopenia who are at risk for spontaneous bleeding, consultation with a specialist and certain pretreatments may be warranted. Evidence: The LNG-IUD may be a useful treatment for menorrhagia in women with severe thrombocytopenia (54).
c) Immunosuppressive treatment	2	1	2
d) None of the above	1	1	2

NEUROLOGIC CONDITIONS

HEADACHES*			I	C	Clarification: Any new headaches or marked changes in headaches should be evaluated.
HEADACHES*
a) Non-migrainous (mild or severe)	1		1	1
b) Migraine
i) without aura
age < 35 years	1		2	2
age > 35 years	1		2	2
ii) with aura, at any age	1		2	3

EPILEPSY	1		1

DEPRESSIVE DISORDERS

DEPRESSIVE DISORDERS	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.

REPRODUCTIVE TRACT INFECTIONS AND DISORDERS

VAGINAL BLEEDING PATTERNS			I	C
VAGINAL BLEEDING PATTERNS
a) Irregular pattern without heavy bleeding	1		1	1
b) Heavy or prolonged bleeding (includes regular and irregular patterns)	2		1	2	Clarification: Unusually heavy bleeding should raise the suspicion of a serious underlying condition. Evidence: Evidence from studies examining the treatment effects of the LNG-IUD among women with heavy or prolonged bleeding reported no increase in adverse effects and found the LNG-IUD to be beneficial in the treatment of menorrhagia (74–81).

UNEXPLAINED VAGINAL BLEEDING (suspicious for serious condition)	I	C	I	C	Clarification: If pregnancy or an underlying pathological condition (such as pelvic malignancy) is suspected, it must be evaluated and the category adjusted after evaluation. There is no need to remove the IUD before evaluation.

Before evaluation	4	2	4	2

ENDOMETRIOSIS	2		1		Evidence: LNG-IUD use among women with endometriosis decreased dysmenorrhoea, pelvic pain and dyspareunia (82–86).

BENIGN OVARIAN TUMOURS (including cysts)	1		1

SEVERE DYSMENORRHOEA*	2		1

GESTATIONAL C TROPHOBLASTIC DISEASE					Evidence: Limited evidence suggests that women using an IUD following uterine evacuation for a molar pregnancy are not at increased risk of developing post-molar trophoblastic disease when compared to women using other methods of contraception (87–90).
a) Decreasing or undetectable β-hCG levels	3		3
b) Persistently elevated β-hCG levels or malignant disease	4		4

CERVICAL ECTROPION	1		1

CERVICAL INTRAEPITHELIAL NEOPLASIA (CIN)*	1		2

CERVICAL CANCER* (awaiting treatment)	I	C	I	C

	4	2	4	2

BREAST DISEASE*
a) Undiagnosed mass	1		2
b) Benign breast disease	1		1
c) Family history of cancer	1		1
d) Breast cancer
i) current	1		4
ii) past and no evidence of current disease for 5 years	1		3

ENDOMETRIAL CANCER*	I	C	I	C

	4	2	4	2

OVARIAN CANCER*	I	C	I	C

	3	2	3	2

UTERINE FIBROIDS*					Evidence: Among women with fibroids, there were no adverse health events with LNG-IUD use, and there was a decrease in symptoms and size of fibroids for some women (91–97).
a) Without distortion of the uterine cavity	1		1
b) With distortion of the uterine cavity	4		4

ANATOMICAL ABNORMALITIES*
a) Distorted uterine cavity (any congenital or acquired uterine abnormality distorting the uterine cavity in a manner that is incompatible with IUD insertion	4		4
b) Other abnormalities (including cervical stenosis or cervical lacerations) not distorting the uterine cavity or interfering with IUD insertion	2		2

PELVIC INFLAMMATORY DISEASE (PID)*
a) Past PID (assuming no current risk factors for STIs)	I	C	I	C
a) Past PID (assuming no current risk factors for STIs)
i) with subsequent pregnancy	1	1	1	1
ii) without subsequent pregnancy	2	2	2	2
b) PID – current	4	2	4	2	Clarification for continuation: Treat the PID using appropriate antibiotics. There is usually no need for removal of the IUD if the client wishes to continue its use (see WHO publication Selected practice recommendations for contraceptive use)¹. Continued use of an IUD depends on the woman's informed choice and her current risk factors for STIs and PID. Evidence: Among IUD users treated for PID, there was no difference in clinical course if the IUD was removed or left in place (98–100).

STIs ^†	I	C	I	C
STIs ^†
a) Current purulent cervicitis or chlamydial infection or gonorrhoea	4	2	4	2	Clarification for continuation: Treat the STI using appropriate antibiotics. There is usually no need for removal of the IUD if the client wishes to continue its use. Continued use of an IUD depends on the woman's informed choice and her current risk factors for STIs and PID. Evidence: There is no evidence regarding whether IUD insertion among women with STIs increases the risk of PID compared with no IUD insertion. Among women who have an IUD inserted, the absolute risk of subsequent PID was low among women with STI at the time of insertion but greater than among women with no STI at the time of IUD insertion (101–108).
b) Other STIs (excluding HIV and hepatitis)	2	2	2	2
c) Vaginitis (including Trichomonas vaginalis and bacterial vaginosis)	2	2	2	2
d) Increased risk of STIs	2/3	2	2/3	2	Clarification: IUD insertion may further increase the risk of PID among women at increased risk of STIs, although limited evidence suggests that this risk is low. Current algorithms for determining increased risk of STIs have poor predictive value. Risk of STIs varies by individual behaviour and local STI prevalence. Therefore, while many women at increased risk of STIs can generally have an IUD inserted, some women at increased risk (very high individual likelihood) of STIs should generally not have an IUD inserted until appropriate testing and treatment occur. Evidence: Using an algorithm to classify STI risk status among IUD users, 1 study reported that 11% of high-STI-risk women experienced IUD-related complications compared with 5% of those not classified as high risk (104). In another small study, the incidence of PID after IUD insertion was low (2.2%) in a cohort of women considered to be high-risk based on high background rates of STIs in the general population (109).

HIV/AIDS ^†

HIGH RISK OF HIV	I	C	I	C	Evidence: Among women at risk for HIV, Cu-IUD use did not increase risk of HIV acquisition (110–120).

	2	2	2	2

ASYMPTOMATIC OR MILD HIV CLINICAL DISEASE (WHO STAGE 1 OR 2)	2	2	2	2	Evidence: Among IUD users, limited evidence shows no increased risk of overall complications or infectious complications when comparing women living with HIV to women not living with HIV. IUD use did not adversely affect progression of HIV when compared to hormonal contraceptive use among women living with HIV. Furthermore, IUD use among women living with HIV was not associated with increased risk of sexual transmission from female to male partners (121–128). One study found no difference in initiation of antiretroviral therapy (ART) or CD4 count between users and non-users of the LNG-IUD (129).

SEVERE OR ADVANCED HIV CLINICAL DISEASE (WHO STAGE 3 OR 4)	3	2	3	2	Clarification for continuation: IUD users with severe or advanced HIV clinical disease should be closely monitored for pelvic infection. Evidence: One study found no difference in ART initiation or CD4 count between users and non-users of the LNG-IUD (129).

OTHER INFECTIONS

SCHISTOSOMIASIS
a) Uncomplicated	1		1
b) Fibrosis of the liver (if severe, see cirrhosis)	1		1

TUBERCULOSIS*	I	C	I	C
TUBERCULOSIS*
a) Non-pelvic	1	1	1	1
a) Pelvic	4	3	4	3

MALARIA	1		1

ENDOCRINE CONDITIONS

DIABETES
a) History of gestational disease	1		1
b) Non-vascular disease
i) non-insulin-dependent	1		2		Evidence: Limited evidence on the use of the LNG-IUD among women with insulin- or non-insulin-dependent diabetes suggests that these methods have little effect on short-term or long-term diabetes control (e.g. HbA1c levels), haemostatic markers or lipid profile (130, 131).
ii) insulin-dependent	1		2
c) Nephropathy/retinopathy/neuropathy	1		2
d) Other vascular disease or diabetes of > 20 years' duration	1		2

THYROID DISORDERS
a) Simple goitre	1		1
b) Hyperthyroid	1		1
c) Hypothyroid	1		1

GASTROINTESTINAL CONDITIONS

GALL BLADDER DISEASE
a) Symptomatic
i) treated by cholecystectomy	1		2
ii) medically treated	1		2
iii) current	1		2
b) Asymptomatic	1		2

HISTORY OF CHOLESTASIS*
a) Pregnancy-related	1		1
b) Past-COC related	1		2

VIRAL HEPATITIS
a) Acute or flare	1		1
b) Carrier	1		1
c) Chronic	1		1

CIRRHOSIS
a) Mild (compensated)	1		1
b) Severe (decompensated)	1		3

LIVER TUMOURS*
a) Benign
i) focal nodular hyperplasia	1		2
ii) hepatocellular adenoma	1		3
b) Malignant (hepatoma)	1		3

ANAEMIAS

THALASSAEMIA*	2		1

SICKLE CELL DISEASE*	2		1

IRON-DEFICIENCY ANAEMIA*	2		1

DRUG INTERACTIONS

ANTIRETROVIRAL THERAPY (ART)					Clarification: There is no known interaction between ART and IUD use. However, severe or advanced HIV clinical disease (WHO stage 3 or 4) as a condition is classified as Category 3 for initiation and Category 2 for continuation. Asymptomatic or mild HIV clinical disease (WHO stage 1 or 2) is classified as Category 2 for both initiation and continuation.
a) Nucleoside reverse transcriptase inhibitors (NRTIs)	I	C	I	C
a) Nucleoside reverse transcriptase inhibitors (NRTIs)
Abacavir (ABC)	2/3	2	2/3	2
Tenofovir (TDF)	2/3	2	2/3	2
Zidovudine (AZT)	2/3	2	2/3	2
Lamivudine (3TC)	2/3	2	2/3	2
Didanosine (DDI)	2/3	2	2/3	2
Emtricitabine (FTC)	2/3	2	2/3	2
Stavudine (D4T)	2/3	2	2/3	2
b) Non-nucleoside reverse transcriptase inhibitors (NNRTIs)	I	C	I	C
b) Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Efavirenz (EFV)	2/3	2	2/3	2
Etravirine (ETR)	2/3	2	2/3	2
Nevirapine (NVP)	2/3	2	2/3	2
Rilpivirine (RPV)	2/3	2	2/3	2
c) Protease inhibitors (PIs)
Ritonavir-boosted atazanavir (ATV/r)	2/3	2	2/3	2
Ritonavir-boosted lopinavir (LPV/r)	2/3	2	2/3	2
Ritonavir-boosted darunavir (DRV/r)	2/3	2	2/3	2
Ritonavir (RTV)	2/3	2	2/3	2
d) Integrase inhibitors
Raltegravir (RAL)	2/3	2	2/3	2

ANTICONVULSANT THERAPY
a) Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine)	1		1		Evidence: Limited evidence suggests that use of certain anticonvulsants does not interfere with the contraceptive effectiveness of the LNG-IUD (132).
b) Lamotrigine	1		1		Evidence: No drug interactions have been reported among women with epilepsy taking lamotrigine and using the LNG-IUD (133).

ANTIMICROBIAL THERAPY
a) Broad-spectrum antibiotics	1		1
b) Antifungals	1		1
c) Antiparasitics	1		1
d) Rifampicin or rifabutin therapy	1		1		Evidence: One cross-sectional survey found that rifabutin had no impact on the effectiveness of LNG-IUD (132).

From: II, Using the recommendations

Cover of Medical Eligibility Criteria for Contraceptive Use

Medical Eligibility Criteria for Contraceptive Use. 5th edition.

Geneva: World Health Organization; 2015.

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