ABSTRACT

Contraception is a crucially important adolescent health issue. Despite recent slight decreases in adolescent pregnancy rates and slight increases in the age of first sexual intercourse across North America, 2003 data still indicate that 33 % of US ninth graders (i.e. aged 14-15 years) and 62 % of twelfth graders (aged 17-18 years), have had sexual intercourse. 1,2 The median age at first intercourse for American males is 16.9 and for females is 17.4. 1 Use of contraception with first intercourse has also increased over recent years; in 2002 75 % of adolescent women and 82 % of adolescent men indicated having used protection with first intercourse. Oral contraceptive pills and condoms were the most common choices. 1,2 Nonetheless, 17 % of adolescent women and 9 % of adolescent men reported having used no method of birth control at last episode of intercourse. 1 In addition, 18 % of adolescent males in the US and 11 % of adolescent females report at least four previous sexual partners, highlighting the role of contraception not only for protection from pregnancy but also in prevention of sexually transmitted infections (STIs). Canadian data are similar, with the average age at first intercourse reported to be 16.5 in a 2005 survey; 41 % of adolescent males and 29 % of adolescent females reported more than one partner in the preceding year and 29 % of males and 51 % of females report not using condoms. 3

An estimated 34 % of American women under the age of 20 will experience a pregnancy. 4 Approximately 20 % of all adolescent pregnancies will occur within the first month of coitus, and 50 % within the first 6 months. Many adolescents will delay seeking contraception for as long as 12 months or more

following sexual debut. Reasons include anxiety that their parents will find out, their sense of invincibility or misconceptions about contraception methods, and the extent of evaluation they anticipate before initiating contraception. 5,6 Dialogue and education around contraception should therefore become part of the routine health exchange with the adolescent before the initiation of sexual activity to promote healthy decision-making on the part of the adolescent. 5 The discussion should also include screening for medical and psychosocial concerns and ruling out coercive sexual activity. The adolescents ’ thoughts in regards to contraception should be explored and any misconceptions should be dispelled. 6 Despite initiating contraception, continuation rates for shorter-term methods such as the oral contraceptive pill over 1 or 2 years has been described to be as low as 12 % and 2 % , respectively. The reasons most commonly cited for discontinuation are running out of pills or forgetting to take them. Close follow-up with the adolescent after the initiation of contraception is therefore crucial to adherence. 6

Discussing contraception with adolescents and educating them in these topics can often be problematic. The medical team and adolescent need to engage in a partnership and work together to find a method that will be successful. Ideally the medical professional should be skilled in interactions with the adolescent age group. 6 Programs and interactions need to be age-appropriate and tailored to the concrete thought processes of the adolescent. Encounters should be kept interactive and should encourage dialogue, such that the adolescent must participate in the exchange and demonstrate their cognitive abilities in selecting their contraceptive. 7

Merely handing out contraception to adolescents and not educating them around contraception use and pregnancy prevention has been shown to be insufficient for improving compliance in this age group. 2 Risk-taking behaviors in regards to sexual activity may be linked to other risk-taking behaviors and the contraception encounter should screen for these issues as well. 8,9 It is further clearly shown that education and discussion around sexual activity do not increase the rates of sexual activity amongst adolescents. 2 More comprehensive youth development programs, which also provide information and counseling around life goals, career planning, and self-esteem, may be successful in reducing teen pregnancy rates. 2

Confidentiality is an extremely important factor in communicating with adolescents; 25 % of adolescents have indicated that they would avoid contacting a health-care provider about a sensitive topic if they felt that their parents would find out. Therefore, health care around contraception should be provided in a confidential and nonjudgmental environment. 7 Nevertheless, physicians are far from the only participants in the arena of adolescents and contraception. Adolescents who are able to experience conversations around these topics with their parents and families are less likely to engage in unprotected intercourse or become pregnant. 10 Greater parental supervision is further associated with increased used of contraceptives. In addition, greater warmth in parental relationships leads to increased likelihood of young women discussing contraception with their male partners. 10 The relationship between the adolescent and parent should be assessed, and the adolescent should be encouraged to openly involve their parents in their health concerns. Further, the attitudes of the partner and the greater social and cultural context should also be part of the information gathered around the contraception encounter, to ensure choice of a successful method and successful adherence to it. 10

Despite the similar characteristics of the youth in the United States and the European Union (EU), significant differences in pregnancy rates are seen. Data suggest that neither the initiation nor frequency of sexual activity but rather the level of utilization of

contraception is the reason for the increase in pregnancy rates in the US. In the EU, not only is there a higher use of contraception, but the reasons for prescribing are different. While in the US many prescriptions are given for the non-contraceptive benefits of the pill, in the EU most prescriptions are given during routine preventive visits, emphasizing the importance of preventive visits and the education given to the patients when started on the method. Education and awareness of teenagers in the US as well as availability of the contraceptive services most likely contribute to the differences from the EU and should be taken into consideration when developing comprehensive programs for contraception in teens. 11,12

While options for all forms of contraception should be discussed with an adolescent, abstinence should be encouraged as the healthiest method of preventing both pregnancy and STIs. Abstinence after a previous experience of sexual activity (secondary abstinence) should also be encouraged as an acceptable choice. 5,13 Adolescents selecting abstinence should be given considerable reassurance and encouragement with regards to their choice being a healthy choice also selected by many of their peers. They should have the opportunity to discuss what behaviors are and are not safe and how to communicate effectively with their partners around which sexual activities they do and do not wish to engage in. 13 Abstinence-only programs have specifically not been shown to reduce age at first intercourse and therefore any counseling or program on abstinence should also provide education around various other methods of contraception in the event that the adolescent later chooses to become sexually active. 2,5

Barrier methods as a whole represent the oldest form of contraception, dating back to the ancient

and available over-the-counter and are therefore an easily accessible form of contraception. 6 Patients can further be advised to obtain condoms ahead of time and keep them in a convenient location in the event that they are needed, but they should be kept out of direct light and extreme heat. 15

Latex condoms are best for STI protection in comparison with natural materials (such as lamb cecum) and should be recommended for all penetrative sexual activity (i.e. vaginal, anal, oral) in addition to any other forms of contraception that are used; dental dams should be advised for STI protection in female receptive oral intercourse. 6 For individuals who are allergic to latex, polyurethane condoms are now available, and while they are stronger and thinner than their latex counterparts and safe to use with oil-based lubricants, they are unfortunately considerably more expensive. 5,14 Polyurethane condoms may be associated with improved sensation for the male partner as well. 14

Female vaginal barriers are also described in ancient texts, when various caustic materials were placed in the vagina to prevent conception. 14 Currently available female barrier methods include the diaphragm, diverse cervical caps and shields, the sponge, and the female condom. 14 In general, adolescents are uncomfortable with the idea of placing barrier methods in the vagina and these methods are therefore unpopular in this age group. Typically, adolescents are inconsistent users of female barrier methods and discontinuation rates average 55 % over 1 year. 6 The highly motivated adolescent, however, may find significant success with these methods. 13 Individuals choosing a female barrier method are more likely to be in monogamous relationships and have to be motivated to use a method that must be contemplated with each act of intercourse. 16,17 There have been associations of barrier methods with toxic shock syndrome with prolonged placement and patients should be counseled with regards to symptoms. Barrier methods are also associated with higher rates of urinary tract

era; male condoms and coverings of the penis are depicted in Ancient Egyptian art, for example. With the advent of newer forms of contraception, their use as a primary method of birth control has declined. 14 As a group, their use poses a challenge in that they are all coitus dependent; however, they can be used selectively and have minimal or no side effects in comparison with other forms of contraception. 14

The word condom is thought to originate from the Latin word condus , meaning receptacle. Condoms were originally made of animal skins but have been manufactured from rubber since the late 1800s. 14 They have become a vitally important tool in public health, in the fight against the spread of human immunodeficiency virus (HIV). 14 Condom use has therefore increased since the advent of the HIV epidemic in the 1980s and the related public health campaigns; data indicate an overall increase in condom use in the US from 12 % in 1982 to 20 % in 1995, with the largest increases in singles and African-American adolescents. 6

Male condoms are the second most popular form of contraception (next to the oral contraceptive pill, (OCP)) and the one most commonly used at first intercourse, likely due to the lack of need for a visit to a health-care provider. 2 School condom distribution programs have been associated with equal rates of sexual activity and small but significantly increased rates in condom use. In general, adolescents are about as consistent with condom use as their older counterparts, in the range of 65 % . 2 Perfect condom use is associated with an efficacy rate of approximately 97 % , although typical use is associated with an 86 % efficacy rate over 1 year of use. 13,14 Spermicide is recommended in addition to any barrier method to improve contraceptive efficacy. 5

Condoms require compliance on the part of the male partner and must be used with each and every act of intercourse. Correct use includes leaving a reservoir in the tip of the condom during application, holding the condom during withdrawal of the penis and removing the condom from the erect penis, as well as avoiding the use of an expired condom. 6,14,15 Importantly, condoms are inexpensive

cervical cap was approved for use in the USA but it was removed from the market in 2005. It comes in four different sizes and can also be fitted for size. The cervical cap, like the diaphragm, should also be used in conjunction with spermicide and can stay in situ for up to 48 hours. 14 Efficacy rates are again variable and similar to those found with use of the diaphragm, but are noted in particular to be decreased in parous women. For reasons that are unclear, there has been an association with the cervical cap and new Pap smear abnormalities; patients are therefore advised to have a Pap smear at the time of cervical cap initiation and again 3 months later. 13

Lea ’ s Shield® (Yama, Inc., Union, NJ, USA), approved for use in 2002, is a silicone vaginal barrier contraceptive that comes in one size and therefore does not need to be fitted by a health-care professional. It has a reservoir for spermicide, a central valve that relieves positive pressure and allows for drainage of cervical secretions, and a loop to aid in removal. 17 Being silicone, it is a suitable barrier method for individuals who are allergic to latex. Efficacy rates are similar to those seen with the diaphragm and may also be lower in parous women. 14,17 The FemCap® (Femcap Del Mar, CA, USA) is also a silicone barrier method; shaped like a sailor ’ s cap with a strap for removal and such that spermicide can be put on the anticervical side. It comes in three sizes, fitted on the basis of the patient ’ s obstetrical history. It can be left in place for up to 48 hours and is associated with less UTIs. It was found to be more problematic in regards to dislodgement, insertion, and removal in trials than were other barrier methods. Based on one trial, its efficacy seemed significantly less than that of the diaphragm. 14,17

The Today® (Allendale Pharmaceuticals, New York, NY, USA) sponge is a disposable, single-use polyurethane sponge 3 inches in diameter and 1.5 inches thick, which contains 1 g of nonoxynol-9 and is inserted vaginally and does not need to be fitted. 13,17 It is moistened before insertion to activate the spermicide (125-150 mg is released over 24 hours) and has a dimple on one side which sits against the cervix and a strap on the other side for

infections (UTIs), possibly related to higher rates of E. coli colonization and pressure on the urethra preventing complete bladder emptying. 14 They can, however, be complicated to use and are less effective than hormonal contraceptives, and these reasons are felt to be associated with their decreased rates of use. 17

The diaphragm was the first widely available barrier method. In 1918, Margaret Sanger was arrested for distributing them. At one time it was used by one-third of women seeking contraception but its popularity has declined since the advent of hormonal contraception in the 1960s. 14 The diaphragm, which has an efficacy of 60-88 % , is a rubber cup with a flat or coil spring rim or wide seal and is designed to fit in the vagina and cover the cervix. It must be fitted by a health-care provider, who measures the distance between the posterior vaginal fornix and the pubic symphysis. It is used in conjunction with spermicide, which should be placed in the cup of the diaphragm before intercourse; additional spermicide should be placed in the vagina with each additional act of intercourse. A 60-80 mm diaphragm will suit most adolescent women well. The diaphragm should be refitted after any pregnancy or pregnancy termination, if the user was virginal at first fitting, after a 10 lb or more weight change, if vaginismus is experienced, and on an annual basis. The diaphragm can be placed up to 6 hours before intercourse and must remain in place for up to 6 hours after intercourse but should not remain in the vagina for over 24 hours in total. 14,17 Efficacy is decreased with frequent coitus, numerous partners, younger age, use of oil-based lubricants, poor instructions for use, prior failure of contraceptive, and ambivalence about pregnancy. 13 Some studies have indicated that diaphragms are associated with a decreased risk of STIs. However, this may not be due to the method itself, but may be more related to the facts that it is often used in association with spermicide and that many diaphragm users are older, well educated, and in monogamous relationships. 14

The cervical cap dates back to the late 1800s. It is smaller than a diaphragm and fits over the cervix, staying in place by suction. The Prentif brand

era. These agents, manufactured commercially since the 1930s, consist of a spermicidal agent (most commonly nonoxynol-9) with a carrier method such as a cream, foam, tablet, jelly or film and can be purchased without a prescription. Patients should be advised to allow the film or tablet to dissolve before intercourse and should also be reminded to use a fresh dose of spermicide before each act of intercourse. These vaginal suppositories can be used alone, with failure rates of 5-50 % in the first year of use. 6,14 They are more often used in conjunction with other male and female barrier methods. In vivo and in vitro efficacy against STIs has been demonstrated. Vaginal spermicides used alone do not decrease rates of HIV transmission. Vaginal odor, irritation, yeast infections, UTIs, and allergic reactions are the primary side effects. In addition, the spermicide may leak out of the vagina after intercourse, which may be distasteful. 6,13,14 Nonoxynol-9 has also been associated with increased rates of HIV transmission in Kenyan sex trade workers, indicating that it is not necessarily effective as a microbicide but rather can increase irritation and abrasion to the vagina. 14

COMBINED ORAL CONTRACEPTIVE PILL

The first oral contraceptive pill (OCP), Enovid-10, debuted in the 1960s. It was developed with money raised by Margaret Sanger and was designed for continuous use. It contained 9.85 mg of norprogestin and 150 µ g of mestranol, an approximately 10-fold increase in the amount of progestin and 4-fold increase in the amount of estrogen compared with modern OCPs. 18 Over the more than four decades that OCPs have been in use, the hormonal doses have decreased and newer, less androgenic progestins have been developed. OCPs contain a combination of ethinyl estradiol and progestin and are packaged to be taken daily for 21 days followed by either 7 days of no pills (21-day packs) or placebo pills (28-day packs), during which time a withdrawal bleed occurs. OCPs can be classified as either

removal. The sponge acts as a physical barrier, releases spermicide, and absorbs sperm; all of these methods decrease the exposure of sperm to the cervix. It can be placed up to 24 hours before intercourse, can be used for multiple acts of intercourse, and should stay in situ for 6 hours after intercourse, for a total of 30 hours in situ . To decrease rates of toxic shock syndrome, it is also recommended that the sponge is not used during menstruation, postpartum or after an abortion. 17 It has similar efficacy to the diaphragm although, like the cervical cap, decreased efficacy is noted in parous women. After being taken off the market in 1995, it has now been available again since 2005. 13,14,17

The female condom was approved for use in the USA in 1993, and is marketed under the name FC Female condom® (formerly the Reality condom®) (The Female Health Company, Chicago, IL, USA). It is a female-initiated method of both contraception and STI prevention. The female condom is a single-use polyurethane sheath, 78 mm wide and 170 mm long, with a ring at either end. It is prelubricated on the inside with a spermicidal lubricant and one ring is placed in the vagina before intercourse and the other open ring sits outside the vagina to allow for intercourse. It can be placed in the vagina up to 8 hours before intercourse. 14 It has been shown to reduce rates of STI transmission in women whose partners refuse to use a male condom. 13 Importantly, however, it should not be used in conjunction with a male condom as the two can adhere to each other and become displaced. 14 While clinical evidence is limited, the polyurethane sheath as well as the small amount of protection provided over the perineum should provide STI protection similar to those observed with the male condom. Efficacy rates are also estimated to be similar to those observed with the male condom. Slippage is a problem noted specifically with the female condom and cost can be prohibitive to use. 14

Descriptions of vaginal spermicidal concoctions date back to Greek writings of the early common

risk with third-generation progestins. The risk of mortality from arterial or venous events attributable to the OCP, for women aged 20-24, is 1 in 370 000 users. 20 There is no significant concern for increase in myocardial infarction (MI) or stroke in nonsmokers under age 35 using the OCP. 21 There are a few drug interactions that may alter the efficacy of the OCP, specifically those that induce the hepatic cytochrome P450 enzyme system; examples include phenytoin, phenobarbital, and primidone. Rifampin and griseofulvin decrease the effectiveness of the OCP. Numerous other antiepileptic medications are associated with increased breakthrough bleeding but do not decrease OCP efficacy. 9

In addition, there are many non-contraceptive benefits to use of the OCP. These include predictable menses, lighter menses, decreased rates of dysmenorrhea, decreased formation of ovarian cysts, decreased rates of pelvic inflammatory disease (PID), decreased ectopic pregnancy rate, a protective effect for endometriosis, improved acne, and reduction in lifetime rates of fibrocystic breast disease. 5,13,21

Newer information on these non-contraceptive benefits of the pill may allow the practitioner to target certain populations with certain formulations. Newer indications such as premenstrual dysphoric disorder (PMDD) with a low-dose (20 µ g ethinyl estradiol) formulation containing drospirenone (3 mg), which has both antiandrogenic and antimineralocorticoid properties, in a 24/4 regimen (24 days active/4 days placebo), has proven to be efficacious in reducing symptoms of PMDD. 22 By the same token this formulation has proven to be efficacious in the treatment of acne. 23 Information on the efficacy of some other formulations in reducing acne that include cyproterone, levonorgestrel or desogestrel may also favor the use of some combinations and allow the patient to obtain multiple benefits with one drug. 24 With respect to malignancy, OCP users have significantly decreased rates of endometrial and ovarian cancers, a possibly reduced risk of colorectal cancer, and increased rates of hepatobiliary and cervical cancer. 21 While there may be a small increased risk of breast cancer

OCPs work in a variety of ways to prevent conception. They exert a negative feedback on gonadotropin-releasing hormone (GnRH), thus preventing ovulation via inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). In addition, cervical mucus is thickened, the endometrium is thinned, and tubal transport is delayed, all of which further decrease the probability of conception. 5,13

Adolescents with medical conditions need to be assessed as to whether there are increased risks to their medical health from the combined OCP. Absolute contraindications would include a personal history of thromboembolic disease, known hypercoagulability, pregnancy, severe hypertension, active breast cancer, migraine with focal neurological symptomatology, active liver disease, cerebrovascular disease, diabetes with end-organ damage, congenital heart disease complicated by structural lesions with turbulent flow or cardiac stents, and cerebrovascular disease. The World Health Organization (WHO) has developed four categories of safety for use of combined OCPs ( Table 15.1 ). 5

Serious adverse reactions to the combined OCP are rare and are fewer in the adolescent population than in older adults. 5 Common adverse reactions include nausea, which typically subsides within the first one or two cycles. Candida vaginitis is also more common in users of the OCP; it can be treated without discontinuing the OCPs. Despite the concerns of adolescents, the current formulations of the OCP are not associated with inherent weight gain but patients must be advised to monitor their food consumption and exercise regimes. 13,19 The risk of a venous thromboembolic (VTE) event has decreased with the development of lower dose OCPs. It is still increased in users of the OCP compared with the general population, with a relative risk of between 3 and 6 according to a 1998 WHO study, with the highest risk in the first year of use. 20 The absolute risk in the healthy adolescent population is still extremely low, in the range of 1.6-5.0 events per 10 000 women, with a slightly increased

Low-dose combined oral contraceptives (COCs) < 35 µg of ethinylestradiol

COCs do not protect against STI/HIV. If there is risk of STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Male latex condoms are proven to protect against STI/HIV

Condition Category I = Initiation C = Continuation

Clarifications/evidence

PERSONAL CHARACTERISTICS AND REPRODUCTIVE HISTORY

Pregnancy NA Clarification : Use of COCs is not required. There is no known harm to the woman, the course of her pregnancy, or the fetus if COCs are accidentally used during pregnancy

Age

a) Menarche to < 40 years 1

b) > 40 years 2

Parity

a) Nulliparous 1

b) Parous 1

Breastfeeding

a) < 6 weeks postpartum 4

b) > 6 weeks to < 6 months postpartum (primarily breastfeeding)

c) > 6 months postpartum 2

Postpartum (in non-breastfeeding women)

a) < 21 days 3

b) > 21 days 1

Post-abortion

a) First trimester 1 Clarification : COCs may be started immediately post-abortion

b) Second trimester 1

c) Immediate post-septic abortion

Past ectopic pregnancy 1

History of pelvic surgery 1

Smoking

a) Age < 35 years 2 Evidence : COC users who smoked were at increased risk of cardiovascular diseases, especially myocardial infarction, compared with those who did not smoke. Studies also showed an increased risk of myocardial infarction with increasing number of cigarettes smoked per day

b) Age > 35 years

(i) < 15 cigarettes/day 3

(ii) > 15 cigarettes/day 4

Obesity > 30 kg/m 2 body mass index (BMI)

2 Evidence : Obese women who used COCs were at increased risk of VTE compared with non-users. The absolute risk of VTE remained small. Data are limited regarding the impact of obesity on COC effectiveness

(Continued )

Blood pressure measurement unavailable

NA Clarification : It is desirable to have blood pressure measurements taken before initiation of COC use. However, in some settings blood pressure measurements are unavailable. In many of these settings pregnancy morbidity and mortality risks are high, and COCs are one of the few methods widely available. In such settings, women should not be denied use of COCs simply because their blood pressure cannot be measured

CARDIOVASCULAR DISEASE

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

3/4 Clarification : When a woman has multiple major risk factors, any of which alone would substantially increase the risk of cardiovascular disease, use of COCs may increase her risk to an unacceptable level. However, a simple addition of categories for multiple risk factors is not intended; for example, a combination of two risk factors assigned a category 2 may not necessarily warrant a higher category

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, 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)

3 Clarification : Evaluation of cause and level of hypertension is recommended, as soon as feasible Evidence : Women who did not have a blood pressure check before COC use had an increased risk of acute myocardial infarction and stroke

b) Adequately controlled hypertension, where blood pressure CAN be evaluated

3 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, COC users with adequately controlled and monitored hypertension should be at reduced risk of acute myocardial infarction and stroke compared with untreated hypertensive COC users

c) Elevated blood pressure levels (properly taken measurements)

(i) systolic 140-159 or diastolic 90-99

3 Evidence : Among women with hypertension, COC users were at increased risk of stroke, acute myocardial infarction, and peripheral arterial disease compared with non-users

(ii) systolic > 160 or diastolic > 100

d) Vascular disease 4

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

2 Evidence : Women who had a history of high blood pressure in pregnancy, who also used COCs, had an increased risk of myocardial infarction and venous thromboembolism, compared with COC users who did not have a history of high blood pressure during pregnancy. The absolute risks of acute myocardial infarction and venous thromboembolism in this population remained small

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

a) History of DVT/PE 4

b) Current DVT/PE 4

c) Family history of DVT/PE (first-degree relatives)

d) Major surgery

(i) with prolonged immobilization

(ii) without prolonged immobilization

(Continued )

e) Minor surgery without immobilization

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

4 Clarification : Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening Evidence : Among women with thrombogenic mutations, COC users had a 2-20-fold higher risk of thrombosis than non-users

Superficial venous thrombosis

a) Varicose veins 1

b) Superficial thrombophlebitis 2

Current and history of ischemic heart disease

Stroke (history of cerebrovascular accident)

Known hyperlipidemias 2/3 Clarification : Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening. While some types of hyperlipidemias are risk factors for vascular disease, the category should be assessed according to the type, its severity, and the presence of other cardiovascular risk factors

Valvular heart disease

a) Uncomplicated 2

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

NEUROLOGIC CONDITIONS

Headaches I C

a) Non-migrainous (mild or severe)

1 2 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 Evidence : Among women with migraine, women who also had aura had a higher risk of stroke than those without aura. Among women with migraine, those who used COCs had a two to four-fold increased risk of stroke compared with women who did not use COCs

(i) without aura

Age < 35 2 3

Age > 35 3 4

(ii) with aura, at any age 4 4

Epilepsy 1 Clarification : If a woman is taking anticonvulsants, refer to the section on drug interactions. Certain anticonvulsants lower COC effectiveness

DEPRESSIVE DISORDERS

Depressive disorders 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 : COC use did not increase depressive symptoms in women with depression compared to baseline or to non-users with depression

(Continued )

REPRODUCTIVE TRACT INFECTIONS AND DISORDERS

Vaginal bleeding patterns

a) Irregular pattern without heavy bleeding

b) Heavy or prolonged bleeding (includes regular and irregular patterns)

1 Clarification : Unusually heavy bleeding should raise the suspicion of a serious underlying condition

Unexplained vaginal bleeding (suspicious for serious condition)

Before evaluation 2 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

Benign ovarian tumors (including cysts)

Severe dysmenorrhea 1 Evidence : There was no increased risk of side effects with COC use among women with dysmenorrhea compared to women not using COCs. Some COC users had a reduction in pain and bleeding

Trophoblast disease 1

a) Benign gestational trophoblastic disease

1 Evidence : Among women with benign or malignant gestational trophoblastic disease, there was no difference in mean times to hCG normalization or incidence of postmolar trophoblastic disease for COC users compared to non-hormonal users b) Malignant gestational

trophoblastic disease 1

Cervical ectropion 1

Cervical intra-epithelial neoplasia (CIN)

2 Evidence : Among women with persistent HPV infection, long-term COC use (≥ 5 years) may increase the risk of carcinoma in situ and invasive carcinoma

Cervical cancer (awaiting treatment)

Breast disease

a) Undiagnosed mass 2 Clarification : Evaluation should be pursued as early as possible

b) Benign breast disease 1

c) Family history of cancer 1 Evidence : Among COC users with a family history of breast cancer, there was no increased risk of breast cancer compared with non-COC users with a family history of breast cancer. Among women with BRCA1 mutations, COC users may have a small increased risk of breast cancer compared with non-users

d) Breast cancer

(i) current 4

(ii) past and no evidence of current disease for 5 years

Endometrial cancer 1

Ovarian cancer 1

Uterine fibroids

a) Without distortion of the uterine cavity

b) With distortion of the uterine cavity

(Continued )

Pelvic inflammatory disease (PID)

a) Past PID (assuming no current risk factors for STIs)

(i) with subsequent pregnancy

(ii) without subsequent pregnancy

b) PID – current 1

STIs

a) Current purulent cervicitis or chlamydial infection or gonorrhea

b) Other STIs (excluding HIV and hepatitis)

c) Vaginitis (including Trichomonas vaginalis and bacterial vaginosis)

d) Increased risk of STIs 1 Evidence : Evidence suggests that there may be an increased risk of chlamydial cervicitis among COC users at high risk of STIs. For other STIs, there is either evidence of no association between COC use and STI acquisition or limited evidence to draw any conclusions

HIV/AIDS

High risk of HIV 1 Evidence : Overall, evidence is inconsistent regarding whether there is any increased risk of HIV acquisition among COC users compared with non-users

HIV-infected 1 Evidence : Limited evidence suggests no association between COC use and changes in RNA levels or CD4 counts among HIV-infected women. There is also limited evidence showing no association between COC use and female to male HIV transmission, and mixed results regarding increased risk of HIV and herpes simplex virus (HSV) shedding among HIV-infected women using hormonal contraception

AIDS On ARV therapy

1 2 Clarification : If a woman is taking antiretroviral (ARV) therapy, refer to the section on

drug interactions. Because there may be drug interactions between hormonal contraceptives and ARVs, AIDS with ARV therapy is classified as Category 2

OTHER INFECTIONS

Schistosomiasis

a) Uncomplicated 1

b) Fibrosis of liver (if severe, see cirrhosis)

Tuberculosis 1

a) Non-pelvic 1 Clarification : If a woman is taking rifampicin, refer to the section on drug interactions. Rifampicin is likely to decrease COC effectiveness

b) Known pelvic 1

Malaria 1

(Continued)

ENDOCRINE CONDITIONS

Diabetes

a) History of gestational disease 1

b) Non-vascular disease

(i) non-insulin-dependent 2

(ii) insulin-dependent 2

c) Nephropathy/retinopathy/ neuropathy

3/4 Clarification : The category should be assessed according to the severity of the condition

d) Other vascular disease or diabetes of > 20 years ’ duration

3/4 Clarification : The category should be assessed according to the severity of the condition

Thyroid disorders

a) Simple goiter 1

b) Hyperthyroid 1

c) Hypothyroid 1

GASTROINTESTINAL CONDITIONS

Gall-bladder disease

a) Symptomatic

(i) treated by cholecystectomy

(ii) medically treated 3

(iii) current 3

b) Asymptomatic 2

Viral hepatitis

a) Active 4

b) Carrier 1

Cirrhosis

a) Mild (compensated) 3

b) Severe (decompensated) 4

ANEMIAS

Thalassemia 1

Sickle cell disease 2

Iron-deficiency anemia 1

DRUG INTERACTIONS

Drugs which affect liver enzymes

a) Rifampicin 3 Clarification : Although the interaction of rifampicin or certain anticonvulsants with COCs is not harmful to women, it is likely to reduce the effectiveness of COCs. Use of other contraceptives should be encouraged for women who are long-term users of any of these drugs. Whether increasing the hormone dose of COCs is of benefit remains unclear

(Continued )

b) Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine)

3 Evidence : Use of rifampicin and certain anticonvulsants decreased the contraceptive effectiveness of COCs

Antibiotics (excluding rifampicin)

a) Griseofulvin 2

b) Other antibiotics 3 Evidence : The contraceptive effectiveness of COCs was not affected by coadministration of most broad-spectrum antibiotics

Antiretroviral therapy 2 Clarification : It is important to note that antiretroviral drugs (ARVs) have the potential to either decrease or increase the bioavailability of steroid hormones in hormonal contraceptives. The limited data available suggest that potential drug interactions between many ARVs (particularly some non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)) and hormonal contraceptives may alter safety and effectiveness of both the hormonal contraceptives and the ARVs. It is not known whether the contraceptive effectiveness of progestogen-only injectable contraceptives (such as depot medroxyprogesterone acetate and norethisterone enantate) would be compromised, as these methods provide higher blood hormone levels than other progestogen-only hormonal contraceptives, as well as than combined oral contraceptives. Studies are under way to evaluate potential interactions between depot medroxyprogesterone acetate and selected PI and NNRTI drugs. Thus, if a woman on ARV treatment decides to initiate or continue hormonal contraceptive use, the consistent use of condoms is recommended for preventing HIV transmission and may also compensate for any possible reduction in the effectiveness of the hormonal contraceptive

From Medical Eligibility Criteria for Contraceptive Use 3rd edn, 2004 with permission. 1. A condition for which there is no restriction for the use of the contraceptive method. 2. A condition where the advantages of using the method generally outweigh the theoretical or proven risks. 3. A condition where the theoretical or proven risks usually outweigh the advantages of using the method. 4. A condition which represents an unacceptable health risk if the contraceptive method is used. Also: 1 Use method in any circumstances; 2 Generally use the method; 3 Use of method not usually recommended unless other more appropriate methods are not available or not acceptable; 4 Method not to be used.