Individual Indications for Birth Control
Contraception is practiced by most couples for personal reasons.
Many couples use contraception to space their children or to limit the size of their family.
Others desire to avoid childbearing because of the effects of preexisting illness on the pregnancy, such as severe diabetes, or heart disease, such as severe aortic stenosis.
As a matter of public policy some countries, especially those that are less developed, promote contraception in an effort to curb undesired population growth.

Methods of contraception

− The available methods of contraception may be classified in many ways.
− For the sake of this discussion, traditional or folk methods are coitus interruptus, postcoital douche, lactational amenorrhea, and periodic abstinence (rhythm or natural family planning).
− Barrier methods include condoms (male and female), diaphragm, cervical cap, vaginal sponge, and spermicides
− Hormonal methods encompass oral contraceptives and injectable or implantable long-acting progestins.
− In addition, the intrauterine contraceptive device (IUD) and sterilization (tubal ligation or vasectomy) contraceptive armamentarium.

A. PERIODIC ABSTINENCE

1. Coitus Interruptus
   Definition

Coitus interruptus involves withdrawal of the entire penis from the vagina before ejaculation.
Fertilization is prevented by lack of contact between spermatozoa and the ovum.
Efficacy
Effectiveness depends largely on the man’s capability to withdraw prior to ejaculation.
The failure rate is estimated to be approximately 4% in the first year of perfect use.
In typical use, the rate is approximately 19% during the first year of use.
Advantages
− Advantages include immediate availability, no devices, no cost, no chemical involvement, and a theoretical reduced risk of transmission of sexually transmitted diseases (STDs).
Disadvantages
− The probability of pregnancy is high with incorrect or inconsistent use.
− Failure may result from escape of semen before orgasm or the deposition of semen on the external female genitalia near the vagina.

2. Lactational Amenorrhea
   Definition:
   − Elevated prolactin levels and a reduction of gonadotropin- releasing hormone from the hypothalamus during lactation suppress ovulation.
   − This leads to a reduction in luteinizing hormone (LH) release and inhibition of follicular maturation.

− The duration of this suppression varies and is influenced by the frequency and duration of breastfeeding and the length of time since birth.
− Mothers only need to use breastfeeding to be successful; however, as soon as the first menses occurs, she must begin to use another method of birth control to avoid pregnancy.
Efficacy
− The perfect-use failure rate within the first 6 months is 0.5%.
− The typical-use failure rate within the first 6 months is 2%. Advantages
− Involution of the uterus occurs more rapidly.
− Menses are suppressed.
− This method can be used immediately after childbirth.
− This method facilitates postpartum weight loss.
Disadvantages
− Return to fertility is uncertain.
− Frequent breastfeeding may be inconvenient.
− This method should not be used if the mother has human
immunodeficiency virus (HIV) infection.

3. Natural Family Planning
   Definition
   − This method involves periodic abstinence, with couples attempting to avoid intercourse during a woman’s fertile period, which is around the time of ovulation.
   − Techniques to determine the fertile period include the calendar method, cervical mucus method, or the symptothermal method.

− The calendar method is based on 3 assumptions as follows: (1) A human ovum is capable of fertilization only for approximately 24 hours after ovulation, (2) spermatozoa can retain their fertilizing ability for only 48 hours after coitus, and (3) ovulation usually occurs 12-16 days before the onset of the subsequent menses.
− The menses is recorded for 6 cycles to approximate the fertile period.
− The earliest day of the fertile period is determined by the number of days in the shortest menstrual cycle subtracted by 18.
− The latest day of the fertile period is calculated by the number of days in the longest cycle subtracted by 11.
− With the cervical mucus method, the woman attempts to predict her fertile period by quantifying the cervical mucus with her fingers.
− Under the influence of estrogen, the mucus increases in quantity and becomes progressively more elastic and copious until a peak day is reached.
− This is followed by scant and dry mucus, secondary to the influence of progesterone, which remains until the onset of the next menses.
− Intercourse is allowed 4 days after the maximal cervical mucus until menstruation.
− The symptothermal method predicts the first day of abstinence by using either the calendar method or the first day mucus is detected, whichever is noted first.
− The end of the fertile period is predicted by measuring basal body temperature.
− The basal body temperature of a woman is relatively low during the follicular phase and rises in the luteal phase of the menstrual cycle in response to the thermogenic effect of progesterone.
− The rise in temperature can vary from 0.2-0.5°C.
− The elevated temperatures begin 1-2 days after ovulation
and correspond to the rising level of progesterone.
− Intercourse can resume 3 days after the temperature rise.

Efficacy
− The failure rate in typical use is estimated to be approximately 25%.
Advantages
− No adverse effects from hormones occur.
− This may be the only method acceptable to couples for
cultural or religious reasons.
− Immediate return of fertility occurs with cessation of use.
Disadvantages
− This is most suitable for women with regular and predictable cycles.
− Complete abstinence is necessary during the fertile period unless backup contraception is used.
− This method requires discipline.
− The method is not effective with improper use.
− The failure rate is relatively high.
− This method does not protect against STDs.
− Epidemiologic studies of women using the rhythm method
have suggested an increased incidence of congenital anomalies such as anencephaly and Down’s syndrome among children resulting from unplanned pregnancies.
− Delayed fertilization has been shown in animal experiments to result in an increased incidence of aneuploidy and polyploidy in offspring, thus suggesting a possible explanation for similar human fetal anomalies.

B. MECHANICAL BARRIERS

1. Male Condom
   Definition

− The condom consists of a thin sheath placed over the glans and the shaft of the penis that is applied before any vaginal insertion.
− Among all of the barrier methods, the condom provides the most effective protection of the genital tract from STDs.
− It prevents pregnancy by acting as a barrier to the passage of semen into the vagina.
Efficacy
− The failure rate of condoms in couples that use them consistently and correctly during the first year of use is estimated to be approximately 3%.
− However, the true failure rate is estimated to be approximately 14% during the first year of typical use.
− This marked difference of failure rates reflects errors in usage.
− Common errors with condoms usage include failure to use condoms with every act of intercourse and throughout intercourse, improper lubricant use with latex condoms (e.g. oil-based lubricants), incorrect placement of the condom on the penis, and poor withdrawal technique.
Advantages
− Condoms are readily available and are usually inexpensive.
− This method involves the male partner in the contraceptive choice.
− Condoms are effective against both pregnancy and STDs. Disadvantages
− Condoms possibly decrease enjoyment of sex.
− Some users may have a latex allergy.
− Condom breakage and slippage decrease effectiveness.
− Oil-based lubricants may damage the condom.

2. Female Condom
   Definition
   − The Reality female condom is a polyurethane sheath intended for one-time use, similar to the male condom.
   − It contains 2 flexible rings and measures 7.8 cm in diameter and 17 cm long.
   − The ring at the closed end of the sheath serves as an insertion mechanism and internal anchor that is placed inside the vaginal canal.
   − The other ring forms the external patent edge of the device and remains outside of the canal after insertion.
   − The female condom prevents pregnancy by acting as a
   barrier to the passage of semen into the vagina.
   − Simultaneous use of both the female and male condom is
   not recommended because they may adhere to each other, leading to slippage or displacement of either device.
   Efficacy
   − Efficacy trials are limited.
   − Initial trials have demonstrated a pregnancy rate of 15%
   in 6 months.
   Advantages
   − The female condom provides some protection to the labia and the base of the penis during intercourse.
   − The sheath is coated on the inside with a silicone-based lubricant.
   − It does not deteriorate with oil-based lubricants.
   − It can be inserted as long as 8 hours before intercourse.
   Disadvantages

− The lubricant does not contain spermicide.
− The device is difficult to place in the vagina.
− The inner ring may cause discomfort.
− Some users consider the female condom cumbersome.
− The female condom may cause a urinary tract infection if
left in vagina for a prolonged period.
− Significant disadvantages may be their cost and overall
bulkiness.

3. Diaphragm
   Definition
   − The diaphragm is a shallow latex cup with a spring mechanism in its rim to hold it in place in the vagina.
   − Diaphragms are manufactured in various diameters.
   − A pelvic examination and measurement of the diagonal
   length of the vaginal canal determines the correct
   diaphragm size.
   − It is inserted before intercourse so that the posterior rim
   fits into the posterior fornix and the anterior rim is placed
   behind the pubic bone.
   − Spermicidal cream or jelly is applied to the inside of the
   dome, which then covers the cervix.
   − It prevents pregnancy by acting as a barrier to the
   passage of semen into the cervix.
   − Once in position, the diaphragm provides effective
   contraception for 6 hours.
   − If a longer interval has elapsed without removal of the
   diaphragm, fresh spermicide is added with an applicator.
   − After intercourse, the diaphragm must be left in place for
   at least 6 hours.
   Efficacy

− Effectiveness of the diaphragm depends on the age of the user, experience with its use, continuity of use, and the use of spermicide.
− The typical-use failure rate within the first year is estimated to be 20%.
Advantages
− The diaphragm does not entail hormonal usage.
− Contraception is controlled by the woman.
− The diaphragm may be placed by the woman in
anticipation of intercourse.
Disadvantages
− Prolonged use during multiple acts of intercourse may increase the risk of urinary tract infections.
− Usage for longer than 24 hours is not recommended due to the possible risk of toxic shock syndrome (TSS).
− The diaphragm requires professional fitting.
− Poorly fitted diaphragms may cause vaginal erosions.
− Diaphragms have a high failure rate. Use of a diaphragm
requires brief, formal training. The diaphragm may develop an odor if not properly cleansed.

4. Cervical Cap
   Definition
   − The cervical cap is a cup-shaped latex device that fits over the base of the cervix.
   − A groove along the inner circumference of the rim improves the seal between the inner rim of the cap and the base of the cervix.
   − The cap must be filled one third full with spermicide prior to insertion.
   − It is inserted as long as 8 hours before coitus and can be left in place for as long as 48 hours.

− A cervical cap acts as both a mechanical barrier to sperm migration into the cervical canal and as a chemical agent with the use of spermicide.
Efficacy
− Effectiveness depends on the parity of women due to the shape of the cervical os.
− With perfect use in the first year, the failure rate for nulliparous women is 9%, as opposed to 20% in parous women.
− With typical use within the first year, the failure rate is 20% in nulliparous women and 40% in parous women.
Advantages

It provides continuous contraceptive protection for its duration of use regardless of the number of intercourse acts.
Unlike with the diaphragm, additional spermicide is not necessary for repeated intercourse.
The cervical cap does not involve ongoing use of hormones.
Disadvantages
− Cervical erosion may lead to vaginal spotting.
− The cervical cap is associated with a theoretical risk of
TSS if it is left in place longer than the prescribed period.
− The cervical cap requires professional fitting and training
for use.
− Severe obesity may make placement difficult.
− It has a relatively high failure rate.
− Candidates must have history of normal results on
Papanicolaou (Pap) tests.

5. Spermicidal Agents

Definition
− Vaginal spermicides consist of a base combined with either nonoxynol-9 or octoxynol.
− The actual spermicidal agent consists of a surfactant that destroys the sperm cell membrane.
− Bases include vaginal foams, suppositories, jellies, films, foaming tablets, and creams.
− These must be inserted into the vagina prior to each coital act.
− Use of spermicidal agents also reduces the risk of infection by both viral and bacterial organisms that cause STDs; however, clinical data on their efficacy for preventing the transmission of HIV are limited.
− Nonoxynol-9 is toxic to the lactobacilli that are part of the normal vaginal flora.
− Adverse effects include increased vaginal colonization with the bacteria Escherichia coli, which may predispose to bacteriuria after intercourse.
− Spermicides prevent sperm from entering the cervical os by attacking the sperm’s flagella and body, reducing their mobility, and disrupting their fructolytic activity, thereby inhibiting their nourishment.
Efficacy
− The perfect-use failure rate within the first year is 6%.
− The typical-use failure rate within the first year is 26%.
Advantages
− The lubrication provided by spermicides may heighten satisfaction in both partners.
− Another advantage is the ease of application.
− Either partner can purchase and apply spermicide
because it is easily accessible, available over the counter,
and inexpensive.
− Applying spermicide requires minimal patient education.

− It augments contraceptive efficacy of the cervical cap and diaphragm.
− Spermicides produce no adverse systemic effects. Disadvantages
− Spermicides provide minimal protection from STDs.
− Insertion may be uncomfortable for some couples.
− Vaginal irritation is possible, and spermicides may cause
an allergic reaction.

C. HORMONAL CONTRACEPTIVES

1. Implants
   Definition
   − The levonorgestrel implants (Norplant) consists of 6 silicone rubber rods, each measuring 34 mm long and 2.4 mm in diameter and each containing 36 mg of levonorgestrel.
   − The implant releases approximately 80 mcg of levonorgestrel per 24 hours during the first year of use, achieving effective serum concentrations of 0.4-0.5 ng/mL within the first 24 hours.
   − The rate of release decreases to an average of 30 mcg/d in the latter years of use.
   − Release of the progestational agent by diffusion provides effective contraception for 5 years.
   − Contraceptive protection begins within 24 hours of insertion if inserted during the first week of the menstrual cycle.
   − The rods are inserted subcutaneously, usually in the woman’s upper arm, where they are visible under the skin and can be easily palpated.
   Mechanism of action

− The mechanism of action is a combination of suppression of the LH surge, suppression of ovulation, development of viscous and scant cervical mucus to deter sperm penetration, and prevention of endometrial growth and development.
Efficacy
− The contraceptive efficacy of the method is equivalent to that of surgical sterilization.
− Overall, pregnancy rates increase from 0.2% in the first year to 1.1% by the fifth year.
Advantages
− The longevity of its effectiveness is an advantage.
− Its effectiveness is not related to its use in regards to
coitus.
− Exogenous estrogen is absent.
− Prompt return to the previous state of fertility occurs upon
removal.
− No adverse effect on breast milk production occurs.
Disadvantages
− A minor surgical procedure is necessary for incision.
− Difficulty in removal is a disadvantage.
− Menstrual irregularities are common along with other
adverse effects, including headaches, mood changes,
hirsutism, galactorrhea, and acne.
− Absolute contraindications include active thrombophlebitis
or thromboembolic disease, undiagnosed genital bleeding, acute liver disease, benign or malignant liver tumors, known or suspected breast cancer, and a history of idiopathic intracranial hypertension.
− Relative contraindications include heavy cigarette smoking, a history of ectopic pregnancy, diabetes mellitus, hypercholesterolemia, severe acne,

hypertension, and a history of cardiovascular disease, severe vascular or migraine headaches, and severe depression.
− Appropriate candidates are women who are postpartum or breastfeeding, women who have difficulty with contraceptive compliance, women in whom pregnancy is contraindicated due to a medical condition, and patients with contraindications to the use of estrogen.
− Adverse effects they may experience, including nausea, headaches, irregular menstrual bleeding, ovarian cysts, weight gain, removal problems, and depression.
− Norplant II (Jadelle) is approved for 3 years of use but has been shown to be effective for as long as 5 years.
− Implanon is a single-rod implant that is 4 cm long and 2 mm in diameter.
− It consists of 68 mg of etonogestrel in an ethylene vinyl acetate copolymer core.
− Etonogestrel is a biologically active metabolite of desogestrel.
− Desogestrel is significantly more potent than levonorgestrel; a serum concentration of 0.09 ng/mL can inhibit ovulation in most women.
− Serum concentrations are adequate for contraception coverage for approximately 3 years.
− Compared with the Norplant system, Implanon is associated with a higher frequency of amenorrhea and oligomenorrhea, a decrease in the prevalence of frequent and prolonged bleeding, and a decrease in the frequency of adverse effects such as weight gain, headache, and acne.
− When the rod is removed, the return to fertility is rapid, with the return of ovulation within 3 weeks.
− Implanon is not associated with loss of bone mineral density (BMD).

2. Injectable Depomedroxyprogesterone Acetate (Depo-Provera)

Definition
− Depo Provera is a synthetic derivative of progesterone administered as an acetate salt (medroxyprogesterone acetate)
− DMPA is a suspension of microcrystals of a synthetic progestin that is injected intramuscularly.
− A progestogen-only hormonal contraceptive birth control drug injected every 3 months
− Very similar to progesterone, a hormone normally produced by the ovaries every month
− Pharmacologically active levels are achieved within 24 hours after injection, and serum concentrations of 1 ng/mL are maintained for 3 months.
− During the fifth or sixth month after injection, the levels decrease to 0.2 ng/mL, and they become undetectable by 7-9 months after injection.
Mechanism
− DMPA acts by the inhibition of ovulation with the suppression of follicle-stimulating hormone (FSH) and LH levels and eliminates the LH surge.
− Similar to oral contraceptives in that it inhibits ovulation
− Synthetic progesterone also causes thickening of cervical
mucous, effectively impeding progress of sperm through
cervical canal
− This results in a relative hypoestrogenic state.
− Single doses of 150 mg suppress ovulation in most women
for as long as 14 weeks.
− The contraceptive regimen consists of 1 dose every 3
months.
− During Pregnancy, Progesterone levels remain high in
order to prevent release of further eggs, as well as
priming the lining of the uterus.
− When not pregnant, Progesterone levels fall and luteolysis
occurs

− Depo Provera mimics the effects of Progesterone, thus, pregnancy.
Efficacy
− DMPA is an extremely effective contraceptive option.
− Neither varying weight nor use of concurrent medications
has been noted to alter efficacy.
− Within the first year of use, the failure rate is 0.3%.
Advantages
− DMPA does not produce the serious adverse effects of estrogen, such as thromboembolism.
− Diminished anemia occurs.
− Dysmenorrhea is decreased.
− The risks of endometrial and ovarian cancer are
decreased.
− It contains no estrogen, thus making it suitable for women
who cannot or will not take estrogen products.
− It also is safe for breastfeeding mothers.
Disadvantages
− Disruption of the menstrual cycle to eventual amenorrhea occurs in 50% of women within the first year.
− Persistent irregular bleeding can be treated by administering the subsequent dose earlier or by prescribing temporary low-dose estrogen therapy.
− Because DMPA persists in the body for several months in women who have used it on a long-term basis, it can delay the return to fertility.
− Approximately 70% of former users desiring pregnancy conceive within 12 months, and 90% of former users conceive within 24 months.
− Similar to the delay in fertility after discontinuation of DMPA, other adverse effects, such as weight gain, depression, and menstrual irregularities, may continue for
as long as 1 year after the last injection.
− The main limitation, from the patient’s point of view, has
been the intramuscular (IM) route of injection, which requires an office visit every 12-14 weeks for administration.
− A subcutaneous version of the drug is now available (depo-subQ provera 104) that delivers a lower dose of medroxyprogesterone acetate (MPA) than does the intramuscular formulation (104 mg vs 150 mg).
− The subcutaneous route opens the possibility for home self-injections, and the lower dose could decrease suppression of pituitary function and ovarian estradiol production.
− Decreases in bone mineral density
− Long-term use has shown to cause bone loss which may
be irreversible
− Affects menstrual bleeding
− After 1 year of use 55% of women encounter amenorrhea
− Delayed return of fertility
− Infants exposed to Depo-provera during pregnancy may
have an increased risk of low birth weight and chance of
death
− Once use is terminated continuous bleeding is possible

3. Progestin-Only Oral Contraceptives
   Definition
   − Progestin-only oral contraceptives, also known as minipills
   − Candidates for use include women who are breastfeeding
   and women with contraindications to estrogen use.
   − Two formulations are available, both of which have lower
   doses of progestin than combined oral contraceptives.
   − One formulation contains 75 mcg of norgestrel.
   − The other has 350 mcg of norethindrone.

Mechanism
− Prevention of contraception involves a combination of mechanisms similar to, but not as efficacious as, combination oral contraceptives.
− Mechanisms of action include (1) suppression of ovulation (not uniformly in all cycles); (2) a variable dampening effect on the midcycle peaks of LH and FSH; (3) an increase in cervical mucus viscosity by a reduction in its volume and an alteration of its structure; (4) a reduction in the number and size of endometrial glands, leading to an atrophic endometrium not suitable for ovum implantation; and (5) a reduction in cilia motility in the fallopian tube, thus slowing the rate of ovum transport.
Efficacy
− Serum progestin levels peak approximately 2 hours after administration.
− Within 24 hours, rapid distribution and elimination returns the level to baseline.
− Greater efficacy is achieved with consistent administration.
− Failure rates with typical use are estimated to be 7% in the first year of use.
− However, any variation can increase the failure rate.
Advantages
− Due to the lack of estrogen, evidence of serious complications to which estrogen can contribute (i.e. thromboembolism) is minimal.
− Noncontraceptive benefits include decreased dysmenorrhea, decreased menstrual blood loss, and decreased premenstrual syndrome symptoms.
− Unlike DMPA, fertility is immediately reestablished after the cessation of progestin-only oral contraceptives.

Disadvantages
− The most significant disadvantage is the continuous need for compliance with usage.
− Users need to be counseled on the need for a backup method of contraception if a pill is missed or taken late.
− A pill is considered late if ingestion occurs 3 hours after the established time of administration.
− If a pill is missed, it should be taken as soon as possible; the next pill should be taken at the scheduled time.
− Backup contraception should be used for the next 48 hours. Unscheduled bleeding and spotting are common even with correct use.
− Other adverse effects include nausea, breast tenderness, headache, and amenorrhea.

4. Combination Oral Contraceptives
   Definition
   − Prior to 1992, the estrogenic component of oral contraceptives consisted of either ethinyl estradiol or mestranol.
   − Today, ethinyl estradiol is used in all preparations containing 35 mcg or less of estrogen in the United States.
   − The progestin component consists of norethindrone, levonorgestrel, norgestrel, norethindrone acetate, ethynodiol diacetate, norgestimate, and desogestrel.
   − The most recent addition to the progestin group is the addition of drospirenone, found in Yasmin birth control pills.
   − The other major new development is the reduction in the dosage of ethinyl estradiol to 20 mcg.
   − The major impetus for this change is to improve the safety and reduce adverse effects.
   − These lower doses are associated with a decrease in the incidence of estrogen-related adverse effects, such as weight gain, breast tenderness, and nausea.

− Monophasic oral contraceptives have a constant dose of both estrogen and progestin in each of the hormonally active pills.
− Phasic combinations can alter either or both hormonal components.
− Use should be initiated either on the first day of the menses or the first Sunday after menses has begun.
− Most of the formulations have 21 hormonally active pills followed by 7 placebo pills.
− This facilitates consistent daily pill intake.
− If a woman misses 1 or 2 pills, she should take 1 tablet as
soon as she remembers.
− She then takes 1 tablet twice daily until coverage of the
missed pills is achieved.
− Women who have missed more than 2 consecutive pills
should be advised to use a backup method of contraception simultaneous to finishing up the packet of pills until their next menses.

Mechanism of action
− Prevention of ovulation is considered the dominant mechanism of action.
− Either estrogen or progesterone alone is capable of inhibiting both FSH and LH sufficiently to prevent ovulation.
− The combination of the 2 steroids creates a synergistic effect that greatly increases their antigonadotropic and ovulation-inhibitory effects.
− They also alter the consistency of cervical mucus, affect the endometrial lining, and alter tubal transport.
Efficacy
− Failure rates are correlated to individual compliance.
− Rates range from 0.1% with perfect use to 5% with typical
use.

Advantages
− Oral contraceptives are used as treatment for menstrual irregularity because menses is more regular and predictable.
− In the prevention of ovulation, oral contraceptives can reduce and sometimes eliminate mittelschmerz.
− Women with anemia secondary to menorrhagia increase their iron stores.
− Women can manipulate the cycle to avoid menses during certain events, such as vacations or weekends, by extending the number intake days of hormonally active pills or by skipping the placebo pill week.
− Oral contraceptives prevent benign conditions, such as benign breast disease, pelvic inflammatory disease (PID), and functional cysts.
− Functional cysts are reduced by the suppression of stimulation of the ovaries by FSH and LH.
− Ectopic pregnancies are prevented by the cessation of ovulation.
− Oral contraceptives are noted to prevent epithelial ovarian and endometrial carcinoma.
− Studies have noted an approximate 40% reduced risk of malignant and borderline ovarian epithelial cancer.
− This protection appears to last for at least 15 years
following discontinuation of use and increases with
duration of use.
− Use of oral contraceptives is associated with a 50%
reduction of risk of endometrial adenocarcinoma.
− Protection appears to persist for at least 15 years
following discontinuation of use.
Disadvantages
− Adverse effects include nausea, breast tenderness, breakthrough bleeding, amenorrhea, and headaches.
− Oral contraceptives do not provide protection from STDs.

− Daily administration is necessary, and inconsistent use may increase the failure rate.
− A few months of delay of normal ovulatory cycles may occur after discontinuation of oral contraceptives.
Metabolic effects and safety
− Venous thrombosis: The estrogen component of oral contraceptives has the capability of activating the blood clotting mechanism.
− Hypertension: Oral contraceptives have a dose-related effect on blood pressure.
− This elevation is believed to be secondary to an estrogen- induced increase in renin substrate in susceptible individuals.
− Atherogenesis and stroke: Although androgens and a few of the progestins actually may increase low-density lipoproteins and decrease high-density lipoproteins, past use of oral contraceptives does not increase the risk of cardiovascular disease.
− The patient who is sedentary, is overweight, smokes heavily, is hypertensive, is diabetic, or has hypercholesterolemia is clearly at risk.
− Hepatocellular adenoma: These benign liver tumors have been associated with the use of oral contraceptives.
− Cancer: The association of oral contraceptive use and breast cancer in young women is controversial.
− The results demonstrated that current oral contraceptive users, and those who had used oral contraceptives within the past 1-4 years, had a slightly increased risk of breast cancer.
− Thus, although the consensus states that oral contraceptives can lead to breast cancer, the risk is small and the resulting tumors spread less aggressively than usual.
− Current thought is that oral contraceptive use may be a cofactor that can interact with another primary cause to stimulate breast cancer.

− The relationship between oral contraceptive use and cervical cancer is also quite controversial.
− A weak association may exist between oral contraceptive use and squamous cell cancer of the cervix.
Contraindications
− Contraindications to use include cerebrovascular disease or coronary artery disease; a history of deep vein thrombosis, pulmonary embolism, or congestive heart failure; untreated hypertension; diabetes with vascular complications; estrogen-dependent neoplasia; breast cancer; undiagnosed abnormal vaginal bleeding; known or suspected pregnancy; active liver disease; and age older than 35 years and cigarette smoking.
− Lastly, drospirenone has antimineralocorticoid properties.
− It is contraindicated in patients with kidney or adrenal
gland insufficiency or liver problems.

5. Ninety-One–Day Combination Oral Contraceptives
   − Currently on the market, 91-day combination oral contraceptives have touted a reduction in menstrual cycles per year.
   − Seasonale is a 91-day oral contraceptive regimen in which tablets containing the active hormones are taken for 12 weeks (84 d), followed by 1 week (7 d) of placebo tablets.
   − Conventional oral contraceptive use is based on a 28-day regimen (21 d of active tablets followed by 7 d of placebo tablets).
   − Seasonale contains a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), which are active ingredients in already approved oral contraceptives.
   − With the Seasonale dosing regimen, the expected menstrual periods that a woman usually experiences are reduced from once a month to approximately once every 3 months.

− As with the conventional 28-day regimen, women experience menses while taking placebo tablets.
− Although Seasonale users have fewer scheduled menstrual cycles, the data from clinical trials show that many women, especially in the first few cycles of use, had more unplanned bleeding and spotting between the expected menstrual periods than women taking a conventional 28-day cycle of oral contraceptive.
− To counteract the unplanned bleeding, a newer version of Seasonale (Seasonique) was developed.
− This new brand completely eliminates the hormone-free interval. Seasonique also has 84 active pills (30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel) but is followed by 7 more active pills (10 mcg ethinyl estradiol) instead of the traditional placebo.
− Therefore, no hormone-free weeks occur.
− The 2 main advantages to replacing the placebo week
with a week of low-dose estrogen are a diminished amount of unplanned bleeding and spotting and fewer or no symptoms (e.g., cramping, bloating, headaches) for women who are sensitive to the placebo-week hormone fluctuations (in particular, low estrogen).
− The risks of using Seasonale are similar to the risks of other conventional combination oral contraceptives and include an increased risk of blood clots, heart attack, and stroke.

6. Combination Patch Contraceptive
   − Available in the United States since 2001, the contraceptive transdermal patch releases estrogen and progesterone directly into the skin (Ortho Evra, Ortho- McNeil Pharmaceutical; Raritan, NJ).
   − Each patch contains a 1-week supply of hormones of both norelgestromin and ethinyl estradiol.
   − It releases a sustained low daily dose of steroids equivalent to the lowest-dose oral contraceptive.

− Advantages include greater compliance and decreased adverse effects, such as nausea and vomiting, due to the avoidance of the first-pass effect.
− However, the patch may cause skin irritation, and, if it is removed unnoticed, such as from showering, this may compromise efficacy.
− Disadvantages and contraindications are similar to those of combination oral contraceptives.
− It may be less effective for women who weigh more than 198 pounds.

7. Contraceptive Vaginal Ring
   − The vaginal rings can deliver progesterone or progesterone-estrogen combinations.
   − The outer diameter of the ring is 54 mm and the cross- sectional diameter is 4 mm.
   − The ring contains 11.7 mg of etonogestrel and 2.7 mg of ethinyl estradiol.
   − It releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol each day.
   − The hormones are released slowly and are absorbed directly by the reproductive organs.
   − The ring is used in the same schedule as oral contraceptives, with 3 weeks of ring usage (ring is left in place for 3 wk) and 1 week without to produce a withdrawal bleed.
   − The ring can be inserted any time during the first 5 days of the menstrual cycle.
   − The ring should be placed in the vagina even if the woman has not finished bleeding, and she should use a backup contraceptive method for 7 days.
   − A new ring should be inserted each month. If the ring comes out during the first 3 weeks of use, it should be washed with lukewarm water and replaced.
   − If the ring-free interval is more than 3 hours, a backup contraceptive method should be used for 7 days.

− The ring should never be left in the vagina for more than 4 weeks.
− If left in for more than 4 weeks, pregnancy should be excluded before inserting a new ring and a backup contraceptive method should be used for 7 days after inserting a new ring.
Advantages
− NuvaRing is highly effective because it results in complete suppression of ovulation.
− The steady release of hormone provides exceptional cycle control.
− The ring is a very effective reversible method of birth control.
− Because daily intake is not a component of NuvaRing contraception, because it is easily inserted and removed by the woman herself, and because return of fertility is rapid upon discontinuation, NuvaRing is a highly acceptable method for women and their partners.
− Because the hormones are absorbed directly into the blood through the vaginal mucosa, the hepatic first-pass metabolism of progestin is prevented.
− The ring delivers the lowest dose of ethinyl estradiol compared with other combined hormonal contraceptives.
− Unlike combined oral contraceptives, the adverse effects of nausea and vomiting are avoided with ring use.
Disadvantages
− Adverse effects include headaches and vaginal irritation or discharge.
− The ring may accidentally slip out during intercourse and either the user or the partner may feel the ring during sexual intercourse.
− Contraindications are similar to those of combined oral contraceptives.

D. INTRAUTERINE DEVICES

− Until as recently as 2000, the only 2 IUDs available in the United States were the Copper T380 (Pregna International; Mumbai, India) and the progesterone-releasing form, Progestasert (Alza; Mountain View, Calif).
− In December 2000, the FDA approved another form of IUD, the levonorgestrel intrauterine system termed Mirena (Berlex Laboratories; Montville, NJ).
− More than 2 million women in Europe have used this form of contraception in the past decade with great success.
Description
− The T-shaped progesterone-releasing IUD Progestasert, which is placed into the uterine cavity, is made of ethylene vinyl acetate copolymer.
− It contains 38 mg of progesterone and minimal amounts of barium sulfate for greater visibility on x-ray films.
− The vertical limbs are 36 mm long, and the horizontal arms are 32 mm wide.
− It has a pair of dark-blue double-strings that hang from the lower limb.
− Approximately 65 mcg/d of progesterone is released from the progesterone form from a reservoir in its stem.
− This is a sufficient amount of hormone to last for 400 days; therefore, this IUD must be replaced yearly.
− The Copper T380 was introduced in 1988.
− The T-shaped IUD is made of polyethylene with fine
copper wire wrapped around the vertical stem.
− The string is clear or white and hangs from the lower limb
of the IUD.
− This device consists of 308 mg of copper covering portions
of its stem and arms.
− Contraceptive effectiveness continues for 10 years, after
which time it must be replaced.

− Mirena is similar in shape to the Copper T380 in that it also consists of a small T-shaped frame with a reservoir that contains levonorgestrel, a progesterone.
− This intrauterine system releases 20 mcg of levonorgestrel per day into the uterine cavity for as long as 5 years.
− An IUD causes cervical mucus to be thicker in consistency, thereby altering sperm migration.
− Uterotubal fluid and motility changes inhibit sperm migration.
− IUDs also result in endometrial suppression.
Efficacy
− The failure rate is 2% with Progestasert (the progesterone form), 0.6% with the Copper T380, and of 0.1 % with Mirena.
Advantages
− IUDs produce no adverse systemic effects.
− Ectopic pregnancies are reduced overall; however, the
ratio of extrauterine to intrauterine pregnancy is
increased if conception does occur.
− Menstrual blood loss and dysmenorrhea are decreased
with Progestasert.
− Twenty percent of women experience amenorrhea with
Mirena.
Disadvantages
− IUDs are associated with a risk of uterine perforation at the time of insertion.
− Increased dysmenorrhea occurs with the Copper T380.
− Increased menstrual blood loss occurs in the first few
cycles with use of the Copper T380 and Mirena IUDs.
− Whether IUDs increase the risk of PID is controversial.

− IUDs have none of the potential noncontraceptive benefits of hormonal contraceptives.
− IUDs may be expelled unnoticed, and they do not protect against STDs.
− Ectopic pregnancies are half as likely in IUD users as they are in women using no birth control.
− Ectopic pregnancies are more likely in women who use Progestasert than the Copper T380; however, the overall risk still remains less than for women who do not use birth control.
− Of those using Progestasert who become pregnant, approximately half of the pregnancies are ectopic.
− However, to reiterate, the risk of ectopic pregnancy is much less than it is in women who do not use any contraception.
− Contraindications include a history of previous PID in the past year or active PID, an abnormal or distorted uterine cavity, undiagnosed genital bleeding, uterine or cervical malignancy, a history of ectopic pregnancy, increased susceptibility to infection (eg, those with leukemia, diabetes, valvular heart disease, or AIDS), Wilson disease, known or suspected pregnancy, a history of genital actinomyces, and active cervical or endometrial infections.

E. STERILIZATION

− Sterilization is considered an elective permanent method of contraception.
− In regard to reversal of sterilization, success is noted to be greater with tubal reanastomosis than with reanastomosis of the vas deferens.

1. Female Sterilization
   − Female sterilization prevents fertilization by interrupting the fallopian tubes.

− Sterilization can be performed surgically in the postpartum period with a small transverse infraumbilical incision or during the interval period.
− Sterilization during the interval period can be performed with laparoscopy, laparotomy, or colpotomy.
− The methods of fallopian tube sterilization include occlusion with Falope rings, clips, or bands; segmental destruction with electrocoagulation; or suture ligation with partial salpingectomy.
− The latest form of female permanent sterilization is the Essure system.
− This form of sterilization prevents fertilization by interrupting the fallopian tubes; however, the Essure system does not require surgical incisions and can be performed with the patient under local anesthesia.
− It is performed hysteroscopically, and a microinsert is placed directly into the fallopian tubes. During the first 3 months after the procedure, the fallopian tube and the microinsert create a tissue barrier that prevents sperm from reaching the egg.
− After the 3-month period, patients must undergo a hysterosalpingogram to ensure placement.
Efficacy
− Rates vary according to the procedure performed.
− The cumulative 10-year failure rate with each method of
tubal ligation is as follows: spring clip method, 3.7%; bipolar coagulation, 2.5%; interval partial salpingectomy, 2%; silicone rubber bands, 2%; and postpartum salpingectomy, 0.8%.
Advantages
− Female sterilization does not involve hormones.
− It is a permanent form of contraception.
− No data indicate that change in libido, menstrual cycle, or
lactation occurs.

− Female sterilization is usually a same-day procedure.
Disadvantages
− Female sterilization is a procedure that involves general or regional anesthesia.
− Patients who undergo the Essure system procedure require a backup method of contraception for the first 3 months.
− It is permanent contraception, and patients may regret the decision later, especially women younger than 30 years.
− If the Essure microinserts must be removed for any reason, major surgery is necessary, requiring an abdominal incision and, most likely, general anesthesia.
− Sterilization does not protect the patient from STDs.
− Sterilization causes short-term discomfort, and it involves
all the risks of surgery.

2. Vasectomy
   − Vasectomy involves incision of the scrotal sac, transection of the vas deferens, and occlusion of both severed ends by suture ligation or fulguration.
   − The procedure is usually performed with the patient under local anesthesia in an outpatient setting.
   − Complications include hematoma formation and sperm granulomas.
   − Spontaneous resolution is rare.
   − After sterilization, remnant sperm remains in the
   ejaculatory ducts.
   − The man is not considered sterile until he has produced
   sperm-free ejaculates as documented by semen analysis.
   − This usually requires 15-20 ejaculations.
   − Vasectomy prevents the passage of sperm into seminal
   fluid by blocking the vas deferens.

Efficacy
− The failure rate is approximately 0.1%.
Advantages
− Vasectomy involves no hormones, is permanent, is an outpatient procedure, is quick, and carries minimal risk with regard to the procedure.
Disadvantages
− Patients may regret their decision after the procedure.
− Alternative contraception is required until the ejaculate is
deemed free of sperm.
− Vasectomy does not prevent STDs.
− Short-term discomfort occurs.

F. EMERGENCY POSTCOITAL CONTRACEPTIVES

− Emergency postcoital contraception is defined as the use of a drug or device to prevent pregnancy after unprotected sexual intercourse.
− A variety of different methods of emergency contraception have been described.
− Emergency contraceptives available in the United States include the emergency contraceptive pills (ECP), the Copper T380 IUD, and the minipill emergency contraception method (MECM).
− Both the Preven kit and the Plan B kit are marketed as emergency contraceptives.
− Candidates for emergency contraception include reproductive-aged women who have had unprotected sexual intercourse within 72 hours of presentation independent of the menstrual cycle.
− No known absolute contraindications to any of these methods have been described because exposure to the high dose of hormones is short lived.

− However, cases of deep vein thrombosis have been documented in women using the ECP method.

1. Emergency Contraceptive Pills and the Minipill Emergency Contraception Method
   − The ECP mode is marketed as Preven.
   − It consists of 2 pills, which each contain 0.5 mg of
   levonorgestrel and 100 mcg of ethinyl estradiol, ingested
   12 hours apart for a total of 4 pills.
   − The first dose should be taken within the first 72 hours
   after unprotected intercourse; however, studies demonstrate effectiveness if the pills are taken after that period.
   − Only the progestin levonorgestrel has been studied for the use in MECM.
   − It is marketed as Plan B.
   − Its treatment schedule comprises 1 dose of 750 mcg
   levonorgestrel taken as soon as possible and no later than 48 hours after unprotected intercourse and a second dose taken 12 hours later.
   − The mechanism action of either the ECP or MECM is not clearly established.
   − If administered before ovulation, both methods may inhibit follicular development and maturation, resulting in anovulation and deficient luteal function.
   − Treatment following ovulation may affect the endometrium, thus inhibiting implantation.
   − They also may affect tubal transport of the sperm or ova.
   − However, menses and fertility return with the next cycle.
   Efficacy
   − Most studies cite an effectiveness rate of 55-94%, with the true effectiveness rate likely to be approximately 75%.
   − Based on one randomized trial comparing the ECP protocol with the MECM, the MECM seems to be just as effective with far less nausea and emesis.

− Patients must understand that the effective rate of 75% does not translate to a 25% failure rate.
− Instead, when considering 100 women who have had unprotected sexual intercourse during the middle 2 weeks of their cycle, approximately 8 will become pregnant.
− Of those 8 who have used ECPs, only 2 will then become pregnant.
− Despite this significant reduction in the rate of pregnancy, patients must understand that this method of contraception should be used only in emergencies and that they should be encouraged to use other more consistent forms of contraception.
− Several factors complicate the calculation of a failure rate.
− Factors include dependence on the patient’s history of
their last menstrual period and day of exposure, effect of regular and irregular menstrual cycles on the calculation of the estimated time of ovulation, the possibility of the patient being pregnant, and the possibility that more than one unprotected coitus has occurred during that period.
Disadvantages
− Adverse effects include nausea and emesis, minor changes in menses, breast tenderness, fatigue, headache, abdominal pain, and dizziness.
− Ectopic pregnancy is possible if treatment fails.

2. Copper T380 Intrauterine Device
   − The Copper T380 IUD can be inserted as many as 7 days after unprotected sexual intercourse to prevent pregnancy.
   − Insertion of the IUD is significantly more effective than either the ECP or MECP regimen, reducing the risk of pregnancy following unprotected intercourse by more than 99%.