Contraceptive options

Hormonal contraceptive methods

Although combined oral contraceptives (COCs) are a popular method of contraception, the effectiveness is dependent on com­pliance and correct use (11).

Synthetic progestogens are used in hormonal contraceptive methods because potent progestins can be used in very low doses and can be delivered through long-acting delivery systems. They are structurally related to testosterone (19-nortestosterone deriva­tives, including the estranes and gonanes) and progesterone (17-OH progesterone derivatives or pregnanes, and 19-norprogesterone derivatives or norpregnanes) (13, 14). The main mechanism of ac­tion is inhibiting ovulation but these preparations also thicken the cervical mucus rendering it impermeable to sperm penetration. Progestogens are usually combined with oestrogen for better cycle control or used alone as a progestogen-only contraceptive (15).

Recently developed progestogens aim to mimic the benefits of pro­gesterone offering more potent progestational and antioestrogenic actions on the endometrium and with a strong antigonadotropic effect but without any androgenic, oestrogenic, or glucocorticoid receptor interaction to prevent unwanted side effects (13, 14).

Minor side effects reported by users include irregular, unpredict­able bleeding and weight gain. Menstrual abnormalities differ with different COC formulations and regimens and in general occur soon after pill initiation, decreasing from 10-30% in the first month to around 10% by the third (17). Weight gain is often perceived as a side effect of using COCs but evidence shows that weight change is the same for COC and placebo users for low-dose products (18).

Serious adverse events, including venous thromboembolism (VTE), are rare among healthy COC users. The risks and benefits of a contraceptive agent against the consequences of unintended pregnancy should be key in the choice of a method. There is an as­sociation with the use of the combined contraceptive pill with an increase in the prevalence of venous thrombosis, pulmonary em­bolism, and myocardial infarction. The prevalence of VTE (8­10:10,000 women-years exposure) and arterial thrombotic events, including myocardial infarction and stroke (1-4:10,000 woman- years exposure), is very rare among healthy, reproductive-age users of modern COCs (19).

There are considerable non-contraceptive benefits associated with COC use. These include improved cycle control and relief from menstrual symptoms, preventing and reducing acne and hirsutism, improved bone health, and prevention of ovarian and endometrial cancer (19).

Several guidelines and ways to maximize the safety of hormonal contraceptive methods have been developed (11, 20). Countries also adapt these guidelines according to their local needs and produce local tools or guidelines. Box 53.2 shows an adaptation for South Africa for absolute contraindications (21).

When initiating a contraceptive method, guidance, such as the WHO MEC evidence-based recommendations, to help the healthcare provider should be accessed. In addition, a WHO-developed effect­iveness chart helps as a counselling tool to advise on the different tiers of contraceptive effectiveness (24) (Table 53.3). This table provides a

Box 53.2 Absolute contraindications to combined hormonal contraception use (pill, patch ring)∕WHO MEC 4: method not to be used

• Smoker (≥15 cigarettes/day), age 35 years or older

• Migraine with aura, any age

• Cardiovascular conditions:

— Elevated blood pressure levels (systolic >160 mmHg or diastolic >100 mmHg)

— Current/history of thromboembolic disorders (deep venous thrombosis or pulmonary emboli) or stroke

— Known thrombogenic mutation

— Current/history of ischaemic heart disease

— Current/history of complicated valvular heart disease (pulmonary hypertension, risk of atrial fibrillation, history of subacute bacterial endocarditis)

• Chronic disease/other conditions:

— Malignant and benign liver tumours (except focal nodular hyperplasia)

— Active viral hepatitis or severe cirrhosis

— Diabetes with vascular complication (nephropathy, neuropathy, retinopathy) or more than 20 years' duration

— Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies

— Acute porphyria with history of crisis

— Major surgery with prolonged immobilization

Source data from National Department of Health, Republic of South Africa.

visual aid indicating contraceptive effectiveness per method, enabling better comparison and assists with the subsequent choice.

Transdermal combined contraceptive system

A continuous daily serum level of 20 mcg ethinyl oestradiol and 150 mcg norelgestromin (the primary active metabolite of norgestimate)

Table 53.3 Comparing effectiveness of family planning methods

Source data from World Health Organization (WHO). Comparing Typical Effectiveness of Contraceptive Methods. Geneva: World Health Organization; 2006. Available at: http:// www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf.

is delivered transdermally through a 20 cm² adhesive patch. The patch is used once a week for 3 consecutive weeks followed by 1 week of non-use which results in a withdrawal bleed. A benefit is that the compliance and continuation rates are better if compared to the COC pill while the efficacy and side effects are comparable with COC pills.

Combined hormonal vaginal ring

This flexible transparent ring measures 4 mm in cross section and 54 mm in diameter and is administered vaginally releasing 15 mcg ethinyl oestradiol and 120 mcg etonogestrel per day. The contra­indications are the same as for the COC pills. The ring is inserted in the vagina and left there for 3 weeks, after which it is removed for a week during which a withdrawal bleed usually occurs. The ef­fectiveness, continuation, and compliance rates are similar to that of COC pill.

Monthly combined injectables

Several injectable preparations that combine a depo progestogen with an oestrogen are available. There are fewer progestogen-related side effects and menstruation still occurs in more than two-thirds of patients. Failure rates are 0.2-0.4% during the first year of use.

Progestogen-only pill

This method exerts its action mainly through thickening the cer­vical mucus and in most clients ovulation is not suppressed. The pill should be taken every day at the same time as the effect on the cer­vical mucus lasts for 22 hours. Progestogen-only pills are usually re­commended to lactating patients, in women after the age of 40 years, or when oestrogens are contraindicated.

Progestogen injections

Depot medroxyprogesterone acetate (DMPA) (12-weekly) and norethisterone enanthate (8-weekly) are used in these preparations. DMPA is used widely in several settings. In addition to the main mechanism of action of suppression of ovulation, the cervical mucus is also altered to prevent sperm penetration. Although the theoret­ical failure rate of this method is very low, continuation rates are poor, mainly due to changes in bleeding patterns.

Adverse effects include irregular bleeding, frequently experienced after the first administration, and amenorrhoea. Weight gain is re­ported due to an increased appetite. Complaints of headache, loss of libido, and depression are sometimes expressed. There is some concern over the loss of bone density in long-term users which ap­pears to be temporary and the bone mass returns to normal after dis­continuation.

Subdermal implants

Several subdermal implants, containing either levonorgestrel (LNG) or etonogestrel are available. These offer a long-acting, reversible contraceptive method (LARC) with the main adverse effects of ir­regular and prolonged bleeding. The main mechanism of action is preventing ovulation but these preparations also thicken the cer­vical mucous. Implants are a very effective contraception option compared with combined hormonal contraception and injectables which rely more on consistent and perfect use. Continuation rates are high and the most common reason for removal of the implant is due to abnormal bleeding patterns.

Emergency contraception

Of the 43.8 million induced abortions in women aged 15-44 in 2005, 49% were judged to be unsafe (25). The aim within clinical service provision is to avoid unsafe abortions through appropriate advice and education. While no emergency contraceptive method offers a 100% guarantee of avoiding pregnancy, emergency contraceptive re­mains very important as backup for many methods of contraception and for women who have had non-consensual coitus (25). There are many misconceptions about the emergency contraceptive and often inadequate information is provided to both service providers and consumers.

Originally Yuzpe introduced the concept of utilizing ethinyl oes­tradiol 100 mcg in combination with dl-norgestrel 1 mg within 72 hours of unprotected coitus and repeated after 12 hours (26). This dosage was available through combined contraceptive preparations and there was a rapid acceptance worldwide of this regimen. The success of treatment was dependent on the time of administration after coitus, and probably the stage of the cycle when this was ac­cessed. The main side effects were nausea and vomiting.

Subsequently, the LNG-only pill was investigated for provision of emergency contraception. The original regimen was 0.75 mg admin­istered twice at 12-hourly intervals. The first dose was ideally admin­istered within 24 hours of unprotected coitus. Subsequent research suggested that a single dose was equally effective and had a lower failure rate than the Yuzpe regimen. Currently, a single dose of 1.5 mg LNG is recommended to avoid non-compliance (27).

The copper intrauterine contraceptive device is a very effective method of emergency contraception and has the advantage of of­fering women efficacy for up to 5 day days after exposure, although earlier use is recommended. In addition it may be utilized as on­going contraception (28).

Mifepristone is a progesterone receptor modulator and is an ef­fective form of emergency contraception (29). The latest review from the WHO suggested that a dose of 50 mg should be utilized for emergency contraception. The initial study used a much higher dose of mifepristone (600 mg) but it is recognized that lower doses are very effective, although many countries only have access to the 200 mg formulation (30).

Ulipristal acetate, a newer progesterone receptor modulator, has been successfully utilized for emergency contraception with good efficacy. It is proven to be less effective in women with multiple ex­posures to pregnancy but has a very acceptable side effect profile and is certainly comparable or superior to levonorgestrel. It must be noted that progestogen-only contraception cannot be initiated straight after the use of mifepristone or ulipristal. At present, we could recommend the use of LNG in lower-resource settings and mifepristone or ulipristal acetate in an environment where this is available (31) (Table 53.4).

The effectiveness of emergency contraception is dependent on the time of the cycle when it is utilized and this is often not recorded (32). It is regularly debated whether many of the women who receive emergency contraception are actually not at risk of pregnancy which obviously impacts the results of any study and makes assessment of success rates more difficult.

Table 53.4 Methods of emergency contraception

Male contraception

The current available male methods of contraception are the condom, withdrawal, and vasectomy, which is regarded as irrevers­ible. Worldwide, male methods are utilized for 10% of contraception use and this rises to 25% in developed countries. The majority of couples utilizing male methods will use condoms which have a high failure rate of 18% in the first year of use (33). There is an unmet need for the development of reversible contraceptive options for men and international surveys have confirmed that many men and women would be willing to utilize new male methods of contracep­tion (34-36).

Considerable research has been undertaken for the development of hormonal male contraception. The use of testosterone to suppress the pulsatile release of gonadotropin-releasing hormone, luteinizing hormone, and follicle-stimulating hormone and thus suppressing endogenous testosterone production and spermatogenesis has in­formed a number of the early clinical trials. The aim of testosterone administration was to provide suppression of spermatogenesis but maintain secondary sexual characteristics and non-gonadal an­drogen effects. For contraceptive efficacy, it is necessary to achieve azoospermia or severe oligospermia, (sperm concentration of sterilization, with fewer complications and the failure rate in the first year is 0.15%. Once postvasectomy azoospermia has been con­firmed, the failure rate is 1 in 2000. It is essential that couples are counselled about the need for backup contraception after the pro­cedure as this becomes effective after about 3 months when azoo­spermia has been achieved or there are less than 100,000 non-motile sperm in an ejaculate.

The postoperative complication rate for all forms of sterilization is low at 1-2%. Sometimes couples present requesting reversal of sterilization and it is essential that counselling includes the fact that sterilization is regarded as a permanent form of contraception, that reversal may not be feasible, and it has to be recognized that in many healthcare settings this will not be available (50).

Only those clients who have the capacity to give fully informed consent can agree to permanent contraception. Offering sterilization to intellectually challenged individuals is largely discouraged. With the availability of the very effective LARC methods, it is possible that sterilization may well become a less popular contraceptive option in the future.

Barrier contraception

These contraceptive methods provide a mechanical or chemical barrier to prevent sperm from passing into the uterus and fallopian tubes to fertilize the ovum. It is essential that they are utilized cor­rectly and consistently and couples need to be very aware of the limi­tations of these contraceptive options. The barrier methods available to our clients include the male and female condoms, spermicides, the cervical cap or vaginal diaphragm, and vaginal sponges (47).

Male condoms are very widely used and are promoted as protec­tion against transmission of HIV and STIs. They provide a physical barrier to prevent sperm from entering the vagina and while their contraceptive efficacy may be limited, their role in transmission of infections is very important. All couples accessing contracep­tion should be counselled on the need and importance of barrier contraception.

Latex condoms provide protection against many STIs but are less effective in preventing infections transmitted by skin-to-skin con­tact such as herpesvirus and human papillomavirus. Polyurethane condoms have a greater incidence of breakage or slippage during coitus and are definitely inferior in terms of infection protection (51). Lambskin condoms are not recommended for STI prevention as most of the viruses which we wish to avoid such as hepatitis B, herpes simplex virus, and HIV pass through the small pores. In gen­eral, latex condoms are considered superior to any of the other avail­able options. Condom use is effective in terms of fertility regulation and perfect use results in a 2% failure rate but typical use has an 18% failure rate.

The female condom is fairly widely available in many low- resource settings. It has a failure rate of 21% with typical use compared with the 5% failure rate with perfect use. Failures occur because of breakage, slippage, misdirection of the condom, and invagination of the condom.

The diaphragm and cervical cap are still used in many countries but are often not available in low-resource settings. The diaphragm provides an intravaginal barrier method which is improved with the use of spermicides. There are several types of diaphragms and the typical success rate of this contraceptive option is 12%. The cervical cap is available in some countries and contributes to the methods of barrier contraception.

There are no non-contraceptive benefits of utilizing barrier contraception and it is advisable that every woman who elects to use this form of contraception is also counselled about emergency contraception and given access to this intervention.

It is recommended that spermicides should be utilized with bar­rier contraception but there is a concern that the most common preparation (nonoxynol-9 gel) results in lesions in the vagina and possibly increased transmission of the HIV virus (52). The use of vaginal microbicides for reducing HIV infection in women has been extensively reviewed (53). The situation where contraception can be combined with both HIV and STI protection is obviously ideal. An acceptable combination of contraception and spermicides has not yet been developed. This is an area for future research and clinical trials.

At present, we would recommend that any woman who may be exposed to HIV infection or STIs should utilize a modern form of contraception plus barrier contraception. Spermicides are not avail­able in many developing countries where HIV prevalence is high and the concern about HIV transmission militates against their use (54).

Natural contraception

Despite the availability of modern contraceptive methods, natural family planning is still practised by a significant number of couples of reproductive age in most countries. These methods include the fertility awareness-based methods and withdrawal. Pregnancy rates of fertility awareness-based methods with perfect use have ranged between 0.3 and 5.0 per 100 users per year. Unfortunately, with typ­ical use, rates of pregnancy rise considerably and therefore this is not a very effective form of contraception (55).

The methods used include the Billings method which assesses cervical mucus, and the symptothermal method which utilizes temperature changes, cycle length, and also cervical mucus. In addition, the standard days method or the calendar days method which inform a woman of the number of days in which she should avoid coitus based on the length of her cycle have also been util­ized. The change of basal body temperature may indicate ovulation has taken place and some couples utilize this. The 2-day method which pays attention only to cervical secretions has also been practised (56).

The lactational amenorrhoea method (LAM) is an important contributor to contraception and is used worldwide. The LAM is only effective when the women is less than 6 months postpartum, is exclusively or nearly exclusively breastfeeding, and is still amenorrhoeic. LAM is 98% effective if used correctly. There are some problems and some contraindications to LAM. Women who are HIV positive have to be very carefully counselled about how they utilize this method. In addition, women with medical con­ditions utilizing certain medications including cytotoxic therapy and high doses of steroids may not be suitable for this form of contraception (47).

The use of withdrawal is often underestimated by clinicians pro­viding contraceptive advice. It has been estimated that over 10% of Canadian women have utilized this as a contraceptive method and an even higher percentage from the United States have reported using coitus interruptus (47). The effectiveness depends on the will­ingness of the couple to be consistent in the use of withdrawal with every act of coitus. With typical use the failure rate may be as high as 22%. Abstinence is also being offered as an option for natural family planning but it is limited by the personal circumstances of the couple.

While many clinicians aim to persuade patients to utilize more reliable forms of contraception other than natural contraception, it is important to recognize that for some couples religious or philo­sophical considerations mean that they do not wish to use modern contraception. In addition, often communities which are perceived as not having access to contraception are in fact utilizing ‘natural’ or ‘traditional’ contraceptive methods (57). This to a certain ex­tent reflects the failure of service provision but indicates their need for contraceptive advice. Where possible, couples should be coun­selled that natural contraception offers no protection against STIs or HIV infection and if barrier methods are acceptable, they should be encouraged to use this together with their traditional or natural contraceptive methods (58).

An overview of long-acting reversible contraception

LARC is a method that requires administration less than once per cycle or month. These methods combine reversibility with high effectiveness because they depend less on compliance or correct use than the short-acting methods such as the COC pills (59, 60). LARC methods include copper IUDs, the LNG-IUS, progestogen- only injectable contraceptives, and progestogen-only subdermal implants.

Benefits of LARC methods include that they are more cost-effective than the COC pill even if only used for 1 year. Studies have reported high satisfaction and continuation rates compared to other contraceptives. These do not include the progestogen-only in­jectable contraceptives which have a poor continuation rate. The use of LARC methods offers the client an effective, long-acting method which requires limited input from the user.