Guidelines 2016 – Hormonal Contraception
Guidelines for Nurse Practitioners in Gynecologic Settings 2016
I. TYPES OF HORMONAL CONTRACEPTION
a. oCs
1. definition
oCs (also known as birth control pills) are pills that when taken by mouth produce systemic changes that prevent conception.
a. types of pills
i. a combination of synthetic estrogen and synthetic progestin
ii. progestin only (also known as minipills)
iii. formulations with additives such as folic acid and iron
iv. Most formulations are to be swallowed whole; one combi- nation of synthetic estrogen and progestin is available in chewable form.
v. oC formulations and regimens vary across products (e.g., type of synthetic progestin and estrogen; combina- tion pills, followed by estrogen-only pills; pills with active ingredients, followed by pills with inactive or other ingre- dients; monophasic, biphasic, triphasic, extended use, and continuous use patterns; short hormone-free interval, estro- gen added during placebo week)
2. directions for use
a. the society of family planning concluded that overweight and obese oC users appear to be at a similar or slightly higher risk of pregnancy compared with women with a normal body mass index (BMi).
b. the combination pill is typically taken for 21 to 24 days and a placebo pill; some with another ingredient (or no pill) are taken for 4 to 7 days, during which time withdrawal bleeding should occur; some packets have 21 oC pills only, so the woman then takes no pills for 7 days.
c. Consecutive use, 12 weeks or more, of a monophasic pill (e.g., seasonale, an 84-combination pill regime) may be
considered in certain situations, or ee and levonorgestrel (e.g., lybrel) taken continuously, including
i. headaches regularly occurring during withdrawal weeks
ii. heavy withdrawal bleeding
iii. endometriosis after workup
iv. patient’s preference
3. directions for use (progestin only): progestin-only pills are taken continuously.
a. indications for using a progestin-only pill
i. a good choice if estrogen is contraindicated
a) smokers
b) lactation
c) history of or current deep vein thrombosis/pulmonary embolism
d) surgery with immobilization
e) Valvular heart disease
f) severe headaches, including migraine without focal neu- rologic symptoms
g) gallbladder disease
h) seizure disorders
i) history of sickle cell disease
ii. elevated blood pressure (Bp) of 140/90 mmhg or greater
b. other considerations for progestin-only methods (benefits may outweigh risks)
i. high risk for breast cancer
ii. gallbladder disease while on combination method
iii. diabetes without vascular involvement (type 1 or 2)
iv. diabetes with nephropathy, retinopathy, and/or neuropathy
v. history of current ischemic heart disease
vi. peripartum cardiomyopathy more or less than 6 months
vii. Moderately or severely impaired cardiac function
viii. rheumatoid arthritis—with or without immunosuppres- sive therapy
ix. history of bariatric surgery
x. endometrial hyperplasia
xi. inflammatory bowel disease
xii. solid organ transplantation—complicated or uncomplicated
xiii. history of cerebrovascular accident
xiv. severe headaches, including migraines, with focal neuro- logic symptoms
xv. Mild cirrhosis (uncompensated)
xvi. diagnosed/treated hypertension
xvii. hiV-positive women (iUd, iUCd)
c. Women who fit the previous criteria after appropriate screen- ing and physical exam may be candidates for progestin only, bearing in mind that irregular bleeding may present a major
clinical problem. Because the number of pills varies with the manufacturer, carefully review instructions on use and pill pack.
4. procedure for pill-related bleeding problems (e.g., amenorrhea, scant menses, breakthrough bleeding)
a. rule out the following
i. faulty oC taking (review packet)
ii. pregnancy
iii. Uterine or cervical pathology—leiomyomata, polyp, cancer
iv. pelvic or vaginal infection
v. drug interference
vi. gastrointestinal problems
vii. endometriosis
viii. thyroid disorder
b. Based on the information gained, treatment is as follows:
i. amenorrhea or scant menses
a) reassure the woman
b) Consider method change
ii. Breakthrough bleeding
a) during the first 3 months of hormone use, reassure only
b) Consider method change
c) Consider sti testing
d) if treatment for a) or b) is unsuccessful and symptoms persist, consult with gynecologist or other collaborating physician.
iii. for hormonal amenorrhea
a) pregnancy test
b) if amenorrhea continues after 6 months and pill has not been changed, change pill; if no withdrawal bleeding, dis- continue pill and consider progestin challenge; if still with no withdrawal bleeding, refer to amenorrhea protocol for workup
iv. if a woman is on any medication that decreases contracep- tive effect, she should be offered the option of backup con- traception, such as condoms and/or spermicidal protection. decisions about hormonal contraceptive use with medica- tions should be individualized. if there is any question about drug interaction and interference of method with other drugs, consult with a gynecologist, other collaborating physicians, or pharmacist.
5. explanation of methods in which oCs are taken2
a. start oC on day 1 (first day of menses), start taking first pill on the first sunday after the menstrual period begins, or quick start by taking the first pill at the time of the office or clinic visit regard- less of the cycle day (with the caveat that if this is after the seventh cycle day, the patient could be pregnant at that time or become pregnant if a backup method is not used for the first 7 days).
b. oC ideally should be taken at the same time of day each day (within an hour either way).
c. Backup contraception is necessary for 7 days (first cycle only) if oCs started later than the fifth cycle day
d. in case of missed pills
i. one pill missed: woman to take pill when she remembers and then take scheduled pill at regular time
ii. two pills missed in first 2 weeks: take two pills at regular time for 2 days. Use backup contraception for the remainder of the cycle.
iii. two or more pills missed in third week: take two oCs daily until all oCs are taken; restart oC cycle with one pill daily within 7 days; use backup contraception until oCs are restarted with a new packet and for the first 7 days of that packet.
iv. three or more pills missed any time in cycle: restart oCs within 7 days with one pill daily. Use a backup method for 7 days of that cycle.
v. if one or more pills are missed and no backup contra- ception was used, the woman could be offered eC (use guidelines for eC). if no withdrawal bleeding occurs, the woman should be instructed to call to discuss a possible pregnancy test.
B. transdermal contraceptive: contraceptive patch ortho evra3
1. definition
the contraceptive patch is a three-layer transdermal polyethylene/ polyester device about the size of a matchbook, with an adhesive on one side. it is impregnated with norelgestromin (ngMn), a syn- thetic progestin, and ee, a synthetic estrogen, and releases 150 mcg of ngMn and 20 mcg of ee every 24 hours.
2. directions for use
a. Women weighing more than 198 pounds (> 90 kg) are at an increased risk for pregnancy. an alternative method is recommended.
b. patch is changed weekly for 3 weeks, then off for 1 week.
3. explanation of method
a. Ways in which the patch is used
i. apply the patch on the first day of menses or on the first sunday after bleeding begins; postpartum non-nursing women, apply at 4 weeks or with resumption of menses.
ii. apply to clean, dry, healthy skin on buttocks, abdomen, upper outer arm, or upper torso. patch should not be applied to the breasts. if applied to the pubic area, it may result in genital swelling.
iii. instruct the woman not to use lotions, cosmetics, creams, powders, or other topical products in area of the patch or area where the patch will be applied.
iv. instruct the woman to press down firmly on the patch for at least 10 seconds and then check if the edges adhere.
v. instruct the woman to check the patch daily.
vi. if the patch detaches, instruct the woman to immediately apply a new patch. supplemental tapes or adhesives should not be used.
vii. apply a new patch the same day of the week 7 days after first patch. repeat this in Week 3.
viii. no patch is applied in Week 4.
ix. Begin a new cycle on the same day of the week as for Week 1 and repeat cycle of 3 weeks on and 1 week off.
x. Withdrawal bleeding will occur during the fourth week.
xi. if the woman forgets to apply a new patch and fewer than 48 hours have passed, she should apply a new patch as soon as she remembers and then apply the next patch on the usual renewal day.
xii. if more than 48 hours have elapsed, the woman should stop the current cycle and immediately begin a new 4-week cycle by applying a new patch. the day for patch renewal will now change. instruct her to use backup contraception for 1 week.
xiii. if the missed change day occurs at the end of the 4-week cycle, instruct the woman to remove the patch and apply a new patch on the usual change day to begin a new cycle.
C. intravaginal contraceptive: contraceptive vaginal ring (nuvaring)
1. definition
the contraceptive vaginal ring is flexible, transparent, colorless, and about 2 in. (5.08 cm) in diameter. it is impregnated with etono- gestrel, a synthetic progestin, and ee, a synthetic estrogen, and releases 120 mcg of progestin and 15 mcg of ee every 24 hours over a period of 3 weeks. note: a new 1-year vaginal ring with nestorone and ee is pending fda approval.
2. explanation of method and ways in which the ring is used
a. insert ring into vagina between days 1 and 5 of the menstrual cycle.
b. Keep ring in place for 3 weeks in a row.
c. remove ring for 1 week for withdrawal bleeding.
d. if the ring is removed and is out of the vagina for more than 3 hours, backup contraception is required for the next 7 days, except for the hormone-free week.
e. offers symptom relief from menorrhagia, dysmenorrhea, poly- cystic ovary syndrome (pCos)
d. intramuscular contraceptive: injectable contraceptive (depo-provera)4
1. definition
the synthetic hormonal substance in depo-provera (depot medroxy- progesterone acetate or dMpa) acts by blocking gonadotropin, thus preventing ovulation from occurring. this injectable decreases
sperm penetration through cervical mucus and causes endometrial atrophy, preventing implantation. it is injected intramuscularly every 12 weeks into the muscle of the upper arm or buttocks.
2. explanation of use
a. depo-provera is injected intramuscularly (in gluteal or deltoid muscle) or subcutaneously in the first 5 days of the menstrual cycle (after onset of menses), within 5 days postpartum, or if breastfeeding, at 4 to 6 weeks postpartum. for women with additional risk factors for loss of bone mineral density (BMd)— cigarette smokers, chronic corticosteroid users—consider sup- plemental use of menopausal doses of estrogen (or another method if risk factors for estrogen use exist).
b. the injection consists of one 150-mg dose administered intra- muscularly or one subcutaneous injection of 104 mg dMpa every 12 weeks for as long as contraceptive effect is desired. if time between injections is greater than 13 weeks, do pregnancy test before administration. inject intramuscularly with a 1.5-inch needle or up to a 3-inch needle (depends on the size of the woman because it needs to be administered deep intramuscularly), or subcutaneously with a 1-inch needle; do not rub the site because rubbing breaks up the microcrystals and increases absorption.
c. depo-provera is available in 150-mg/ml and 104-mg/0.65-ml prefilled syringes, as well as in single- and multiple-dose vials. Visit every 12 weeks for injection. Counsel the woman about age-appropriate calcium and vitamin d intake.
d. note the black box warning about the effects on BMd; the society for adolescent Medicine noted benefits outweigh risks; loss of BMd is reversible.
e. Contraceptive implant: nexplanon
1. definition
a single-rod, implantable polymer contraceptive device impreg- nated with 68 mg of etonogestrel; effective for up to 3 years
2. explanation of use
a. inserted subdermally on the inner side of the woman’s upper arm; releases a low, steady dose of the synthetic progestin etonogestrel
b. nexplanon is radiopaque; may use x-ray, Ct scan, ultrasound, or Mri to locate once implanted
II. PHYSICAL CHANGES OCCURRING WITH HORMONAL CONTRACEPTION
a. ovulation is suppressed.
B. the endometrium becomes deciduous, making it unreceptive to implantation.
C. the cervical mucus is altered, so it is hostile to sperm.
d. transport of the ovum may be altered.
e. possible luteolysis
f. possible inhibition of capacitation of sperm
III. EFFECTIVENESS
a. 99.6% effectiveness rate for combination pill
B. 97% effectiveness rate for progestin-only pill
C. 98% to 99% effectiveness rate for vaginal contraceptive ring
d. 99% effectiveness for contraceptive patch
e. +99% effectiveness for contraceptive injectable
f. +99% effectiveness for contraceptive implant
IV. CONTRAINDICATIONS
a. absolute contraindications to hormonal contraception (may vary with method)5.
1. thromboembolic disorder (or history thereof), including deep vein thrombosis, pulmonary embolism, or thromboembolism; stroke
2. thrombotic cerebrovascular accident (or history thereof)
3. Coronary artery disease (or history thereof) or multiple risk fac- tors for arterial cardiovascular disease; current angina pectoris; structural heart disease complicated by pulmonary hypertension; atrial fibrillation; valvular heart disease with complication
4. Known or suspected carcinoma of the breast
5. Major surgery with prolonged immobility or any surgery on the legs
6. Known impaired liver function at present time, liver problems, hepatic adenoma, liver cancer or history of active viral hepatitis, severe cirrhosis, benign or malignant liver tumor with prior oC use or other estrogen product
7. Known or suspected estrogen-dependent neoplasm (or history thereof), including endometrial carcinoma
8. older than 35 years of age and currently a smoker
9. triglyceride level greater than 350 mg/dl; hypercholesterolemia (type 2 hyperlipidemia)
10. Known or suspected pregnancy
11. Chronic hypertension and smoking or uncontrolled hypertension; vascular disease
12. Undiagnosed abnormal vaginal/uterine bleeding
13. history of hormonal contraception-related cholestasis or choles- tatic jaundice of pregnancy
14. leiden factor V mutation
15. allergic reaction to any components of the ring, patch, or depo- provera or any of its ingredients (check allergic reaction to local anesthetics for dental or other procedures—the carrier substance is the same for local anesthetics and depo-provera)
16. Migraines with aura at any age
17. diabetics with nephropathy/retinopathy/neuropathy or diabetes of longer than 20 years duration
18. Breastfeeding less than 6 weeks postpartum
B. relative contraindications
1. severe headaches or common migraines, which start or worsen with initiation of hormonal contraception use, especially in women 35 years or older
2. hypertension with resting diastolic Bp of 90 or more, resting systolic Bp of 140 or more on three or more separate visits, or an accurate measurement of 110 diastolic Bp or more on a single visit
3. impaired liver function (i.e., acute phase mononucleosis, medica- tion-induced changes)
4. hypertriglyceridemia; worrisome ratio of low-density lipoprotein (ldl) to high-density lipoprotein (hdl)
5. gallbladder disease: medically treated, current biliary tract disease
C. other considerations (advantages of hormone contraception generally outweigh disadvantages)
1. diabetes: without vascular disease
2. Congenital hyperbilirubinemia (gilbert’s disease)
3. failure to have established regular menstrual cycle (without prior workup; see amenorrhea guideline in Chapter 16)
4. Conditions likely to make it difficult for the woman to use the method correctly and consistently (learning disability, major psychiatric problems, alcoholism or other drug abuse, history of repeatedly taking oCs or other medications incorrectly)
5. Major surgery with no prolonged immobilization
6. Undiagnosed breast mass
7. Cervical cancer awaiting treatment; cervical intraepithelial neoplasia (Cin)
8. Use of drugs affecting liver enzymes (altering absorption of the medication): phenytoin, carbamazepine, barbiturates, topiramate, primidone, rifampin, rifabutin, griseofulvin
9. younger than 35 years of age and heavy smoker (more than 15 cigarettes per day)
10. Use in breastfeeding may decrease milk supply.
11. skin disorder that may predispose to application site reactions
12. risk factors for low BMd (cigarette smoking, corticosteroid use)
13. Weight of more than 198 pounds (more than 90 kg; BMi greater than 30); weight may decrease efficacy with some pills
V. ADVERSE DRUG INTERACTIONS
a. all women prior to starting hormonal contraception, and on a yearly follow-up basis, should review and re-sign the informed consent for method of choice—emphasizing drug interaction and knowledge of danger signs.
B. if a woman is on any medications that decrease contraceptive effect, she should be offered the option of a backup contraception method, such as condoms and/or spermicidal protection. decisions about hor- monal contraceptive use with medications should be individualized.
if there is any question regarding drug interaction and interference of the method with other drugs, consult with a gynecologist or pharmacist.
C. drug interactions with oral contraception: some drugs can decrease the effectiveness of oCs by decreasing the available level of hor- mones. this can result in pregnancy. drugs that may decrease the effectiveness of oCs include but are not limited to
1. antibiotics
a. Cephalosporins
b. Chloramphenicol
c. Macrolides
d. penicillins
e. tetracyclines
f. sulfas
2. hiV protease inhibitors
a. amprenavir
b. nelfinavir mesylate
c. ritonavir
d. Modafinil
3. rifamycins
a. rifampin
4. antiseizure medications
a. Barbiturates
b. Carbamazepine
c. phenytoin
d. primidone
e. topiramate
5. st. John’s wort
VI. LABORATORY EXAMINATION
a. lipid screen
1. lipid screen prior to using hormonal contraception; significant immediate family history
a. younger than 50 years of age—stroke, coronary, or sudden death
b. do a lipid screen. if levels are abnormal, consult with a physi- cian before starting hormonal contraception. if levels are nor- mal, start hormonal contraception and repeat test in 2 years.
c. lipid screen is strongly advised if parents or siblings have hypertension, vascular disease, myocardial infarction, arterio- sclerotic heart disease, and/or hyperlipidemia before the age of 50 or are on medication for hypertension.
B. Monitor carefully any prediabetic and diabetic women using hor- monal contraception. Consider screening with fasting blood sugar and/or 2-hour postprandial blood sugar if parents or siblings are dia- betic or if the woman is otherwise at an increased risk of developing diabetes.
C. liver profile if the woman has had mononucleosis or mono-like ill- ness within the past year or if the patient has a history of hepatitis or other liver disease or drug or alcohol history
d. in combination hormonal methods, leiden factor V for women with a personal or family history of venous thromboembolism
VII. FOLLOW-UP
a. for all methods of hormonal contraception
1. Bp check as needed
2. smoking cessation counseling
3. review of side effects and danger signs
B. for injectables
1. depo-provera
a. revisit every 12 weeks
b. if more than 13 weeks have passed since the last injection, use a very sensitive pregnancy test prior to injection.
See Appendix A for consent form and informational handout on OCs for patients.
See other appendices for informational handouts on other hormonal methods.
See Bibliographies.
Website: www.implanon-usa.com