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Update on Contraception 2014 Catherine Waits, MSN, APRN KCNPNM Conference April 2014.

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1 Update on Contraception 2014 Catherine Waits, MSN, APRN KCNPNM Conference April 2014

2 OBJECTIVES: 1.Recognize that unintended pregnancy is a primary health concern 2.List varieties of contraceptive methods. 3.Identify risks, benefits and side effects of the various contraceptive methods. 4.Identify contraceptive methods that are safe to use with certain medical conditions. 5.Review principals of emergency contraception 1.Recognize that unintended pregnancy is a primary health concern 2.List varieties of contraceptive methods. 3.Identify risks, benefits and side effects of the various contraceptive methods. 4.Identify contraceptive methods that are safe to use with certain medical conditions. 5.Review principals of emergency contraception

3 Why do we care? “No woman is completely free unless she is wholly capable of controlling her fertility and… no baby receives its full birthright unless it is born gleefully wanted by its parents.” – Alan F. Guttmacher

4 Percentage of Women Experiencing Unintended Pregnancy in First Year of Using Contraceptive Hatcher RA. Contraceptive Tech. 19th ed * Standard Days Method: 5%, Two Day Method: 4%

5 FP-1 Increase the proportion of pregnancies that are intended FP-1 Increase the proportion of pregnancies that are intended Intended pregnancy (females 15 – 44 years) 2002 Baseline: 51.0 % 2020 Target: 56.0% Graph: Center on Children and Families at Brookings Report, Policy for Preventing Unplanned Pregnancy March 2012

6 Counseling Considerations Future pregnancy plans ▫“When do you plan to get pregnant?” Patient’s health history ▫Consider special needs ▫U.S. Medical Eligibility Criteria for Contraceptive Use 2010 (US MEC) Efficacy of contraceptive ▫Review the typical failure rate of the methods Patient Preference ▫Reduce barriers to contraception ▫U.S. Selected Practice Recommendations for Contraceptive Use (US SPR)

7 Menstrual Cycle

8 The Menstrual Cycle Chart copied from http.//gettingpregnant.com/menstrual-cycle Hatcher RA & Namnoum AB (2004)

9 Contraceptive Hormonal Effects ESTROGEN ↓ follicle-stimulating hormone release Suppresses LH surge Blocks ovulation Endometrial effects ↑ HDL cholesterol ↓ LDL cholesterol Triglycerides levels are slightly ↑ ↑ liver production of serum globulins involved in coagulationPROGESTIN ↓ luteinizing hormone secretion Blocks ovulation Thickens cervical mucus Slows tubal motility Induces endometrial atrophy ↑ LDL ↓ HDL & Triglycerides No effect on coagulation factors

10 Contraceptive Mechanism of Action Suppress ovulation Change endometrium making implantation less likely Thicken cervical mucus (preventing sperm penetration) Reduce sperm transport in upper genital tract (fallopian tubes) Hatcher & Namnoum (2004

11 Contraceptive Options: Natural Hormonal Contraceptives Barrier Methods

12 CONTRACEPTIVE OPTIONS: HORMONAL ORAL CONTRACEPTIVES VAGINAL RING TRANSDERMAL IMPLANT INTRAUTERINE INJECTION NON-HORMONAL CONDOMS (male and female) DIAPHRAM CERVICAL CAP SPONGE FOAM NATURAL FAMILY PLANNING CERVICAL MUCUS OVULATION DETECTION METHOD LACTATIONAL AMENORRHEA METHOD WITHDRAWAL INTRAUTERINE COPPER IUD STERILIZATION

13 Combined Hormonal Contraceptive Methods “CHC” Ethinyl Estradiol + one of 7 different Progestins Efficacy Rate: Perfect Use=0.1 pregnancies / 100 women Typical Use=3 pregnancies / 100 women “Low Dose” is 35 mcg or less Monophasic or Multiphasic Pills Extended Dose 24 day/ 91 day Vaginal Ring (NuvaRing) Transdermal Patch (Ortho-Evra) Convenient, easy to use, user control Does not interfere with intercourse 54 mm 4 mm Dickey RP (2010) Zieman M (

14 Combined Hormonal Contraceptives  Improvement of cycle-related conditions: Acne Irregular menstrual cycles Dysmenorrhea Menorrhagia Anemia Functional ovarian cysts  Reduction in cancer of certain organs: Ovary Endometrium Colon and rectum  Early side effects Nausea Breast tenderness Headache Oily skin (acne may worsen or improve)  Mood changes  Weight gain  Breakthrough bleeding  Other side effects Thromboembolic effects (rare) Benefits Side Effects

15 CONTRAINDICATIONS : COMBINED HORMONAL CONTRACEPTIVES  THROMBOEMBOLIC DISORDERS  Deep Vein Thrombosis; Pulmonary Embolism  Blood Clotting Disorders i.e. Factor V Leiden  Family History of thrombophilias  CARDIOVASCULAR DISEASE  MIGRAINE WITH AURA  UNCONTROLLED HYPERTENSION >140/90  MAJOR SURGERY WITH PROLONGED IMMOBOLIZATION  CIGARETTE SMOKING IN WOMEN GREATER THAN 35 YEARS  BREAST CANCER: CURRENT OR PAST Reproductive Health Access Project (2012 )

16 Combined Hormonal Contraceptive Key Points CHC contain ESTRIDIOL and one of seven available PROGESTINS ▫Low Dose Estrogen is safe, effective, convenient, rapidly reversible Extended-cycle regimens decrease menstrual bleeding and symptoms associated with the traditional hormone-free interval CHC benefits: ▫Cycle control: less bleeding, less cramping, suppression of endometriosis ▫Fewer ovarian cysts ▫Decreased fibrocystic breast changes ▫Favorable impact on lipids: increased HDL and reduces LDL ▫Decreased risk of ovarian and endometrial cancers

17 OCP FORMULATIONS

18 Norethindrone (Junel 1/20) Medroxyprogesterone acetate (Depo Provera) 1 st Generation Levonorgestrel (Lo Seasonique) Norgestrel (Cryselle) 2 nd Generation Desogestrel (Apri, Desogen) Etonogesterol (Nuva ring, Nexplanon) 3 rd Generation Drospirenone (Yaz) Dienogest (Natazia) Nomegestrol Acetate (Patch) 4 th Generation Progestins in Combination Contraceptives Davtyan (2012)

19 Oral Contraceptive Products NameEthinyl EstradiolProgestinCharacteristics LoSeasonique Loestrin 1/20 20 mcg Levonorgestrel 0.1 mg Norethindrone acetate 1 mg Regular or light menses 2-4 d Mild or no cramps Mircette Ortho Tricyclen Lo 20 mcg 25 mcg Desogestrel 0.15 mg Norgestimate 0.180/ 0.215/0.250 Regular or mod. menses 4-6 d Moderate cramps Ovral (Norinyl 1/35) 50 mcg 35 mcg Norgestrel 0.5 mg Norethindrone 1.0 mg Regular Heavy menses 6+ d Severe cramps Alesse Yaz 20 mg Levonorgestrel 0.1 mg Drospirenone 3.0 mg Irregular menses. Acne, oily skin, hirsutism LoSeasonique Ortho-Micronor 20 mcg Levonorgestrel 0.1 mg Norethindrone 0.35 mg H/O excessive nausea & edema during pregnancy H/O fibroids; fibrocystic breasts Alesse Ortho Tricyclen Lo 20 mcg 25 mcg Levonorgestrel 0.1 mg Norgestimate 0.180/ 0.215/0.250 H/O excessive pregnancy weight gain & varicose veins Depression; Premenstrual edema Ortho Tricyclen Lo Ortho Novum mcg 35 mcg Norgestimate Norethindrone Weight less than 110 pounds Ovral (Ortho Novum 777) 50 mcg 35 mg Norgestrel 0.5 mg Weight more than 160 # Dickey RP (2010) pg

20 Transdermal Contraceptive Patch

21 Transdermal Contraceptive Patch: Application Size: 4.5 cm square patch Ethinol Estridiol 20 mcg plus Norelgestromin 150 mcg Efficacy may be diminished with women over 198# Apply weekly for 3 weeks then 1 week off for withdrawal bleeding  Apply to buttocks upper outer arm lower abdomen upper torso (excluding the breast)

22 Transdermal Contraceptive Patch AdvantagesDisadvantages  Weekly application encourages compliance  Easy verification of presence reassures user of continued protection  Does not require vaginal insertion  Contraceptive effects are rapidly reversible  Excellent cycle control after 3 months  Application site reactions  Not as effective in women weighing >198 pounds  Side effects are similar to oral contraceptives except for:  Higher rates of breast pain during first 2 months  Higher rates of dysmenorrhea  May be difficult to conceal  No protection against HIV or other sexually transmitted infections

23 Vaginal Contraceptive Ring

24 Vaginal Contraceptive Ring: Provides continuous delivery of:  Ethinyl estradiol 15 mcg —  lower dose of estrogen than used in OCP’s  Etonogestrel 120 mcg—the active metabolite of desogestrel The vaginal ring is flexible, easy to insert and remove. The ring is worn for three weeks then discarded. A new ring is inserted one week later for a 28- day cycle. Initiate with “quick start” if reasonably certain pt is not pregnant

25 There is no wrong way to insert the ring. If it lies comfortably in the vagina, it has been placed correctly. Vaginal Contraceptive Ring: Insertion

26 Vaginal Ring AdvantagesDisadvantages  Self-administered  Patient does not have to take daily  Low dose estrogen  Less side estrogenic side effects generally no nausea, or breast tenderness  Does not affect lipoproteins  Effective for all body types  Steady-state hormone levels  Shorter, lighter periods  Some breast tenderness  Weight neutral  Increase in vaginal discharge  Headache  Vaginitis  Must digitally self insert

27 Drug Interactions Interactions between CHC and other medications may occur. Interactions resulting in reduced contraceptive efficacy are of most concern. Spotting or breakthrough bleeding may occur. Advise to use back-up method if using antibiotic

28 Side Effect Management Break Through Bleeding ▫Any woman beginning a new form of hormonal contraception  For adolescents, breakthrough bleeding may discourage continued use Women who inconsistently use oral contraceptives or miss doses Skipping even one pill can result in BTB CHC users who have chlamydial cervicitis and/or endometritis Consider infection if BTB occurs after several cycle uses ▫Smokers have a 30% increase in BTB due to anti-estrogenic effects Burkman RT (2007) Lohr PA & Creinin MD (2007) Barr NG (2010)

29 Side Effect Management Nausea ▫Take pill at bedtime, or at a meal ▫Use low estrogenic activity pill Fluid Retention ▫Change to low estrogenic activity pill Increased Appetite/Weight Gain ▫Change to Low Estrogen Activity and Low Androgenic Activity Pill ▫Low Estrogenic Pills:  Any 20 mcg EE pill ▫Low Progestin Pills :  Alesse,  TriNorinyl, OrthoTriCyclen Lo Menstrual Migraine Headaches ▫Change to OCP with Low Estrogenic Activity ▫Progesterone Only OCP ▫Continuous cycle Major Depression ▫Use OCP with Low Progestin Activity ▫Low Adrogenic Pills:  Orthotricyclen Lo  Ortho Cyclen  Mircette,  Natazia,  Yaz Dickey 2010 (14th Ed)

30 Oral Contraceptives and the Risk of Cardiovascular Event: Stroke, MI, VTE Helping Your Patients Decide: Making Informed Health Choices About Hormonal Contraception (June 2006) Association of Reproductive Health Professionals

31 Side Effect Management Hypertension ▫If previous HTN during pregnancy, use with caution and monitor ▫B/P relatively well-controlled==use CHC with caution ▫Consider Progestin-Only or Non-Hormonal Method Reproductive Health Access Project (2013)

32

33 Oral Contraceptives and the Risk of Breast Cancer “Our analyses suggest that associations between ever use of OCs and ovarian and breast cancer among women who are BRCA1 or BRCA2 mutation carriers are similar to those reported for the general population” Moorman PG, et al. (2013) “No significant increase in breast cancer risk associated with COC use has been found in case-control studies in BRCA1 (OR: 1:08; p= ), in BRCA2 (OR: 0.80; p=0.147).” Cibula D, Sikan M, Dusek L, Majek O. (2011). “ In a majority of studies there is no increase in the risk of breast cancer reported in OC users. ” Cibula D, et al. (2010) “ In our study oral contraception was not associated with a significantly increased risk of any cancer. ” Hannaford, PC et al (2007)

34 Progestin-Only Contraceptives

35 Progestin Effects of Contraceptive Hormones Decreases luteinizing hormone secretion Blocks ovulation Thickens cervical mucus Slows tubal motility Induces endometrial atrophy Increases LDL Decreases HDL & Triglycerides No effect on coagulation factors

36 Candidates for Progestin-Only Contraceptives Women with contraindications for combination hormonal contraceptives, including a history of: ▫Venous thrombosis ▫Vascular disease ▫Hypertension ▫Heavy smoking (>35 years) Lactating women

37 Progestin-Only Oral Contraceptives “Mini-Pill” or “POP” Two formulations: Norethindrone & Norgestrel Efficacy Rate: ▫Perfect Use= 0.5 pregnancies / 100 women ▫Typical Use= 3 pregnancies / 100 women Consistently timed ingestion is required ▫Plasma levels fall to baseline after 24 hours ▫If ingestion occurs more than 3 hours after a required dose, back-up contraception should be used for 48 hours Dickey RP (2010) Zieman M, et al. ( )

38 Progestin Only Methods Advantages Disadvantages  Estrogen-free  Safe in breast-feeding  Can be used in sickle-cell disease, HTN, Lupus, stroke, migraine, smokers >35 years  Self-administered for POP  Long Acting Reversible Contraception (Injection, Implant and Intrauterine)  NO change in ovulation and menses after stopping Implant or IUS  Oral must be taken every day at the same time  Every pill is an active pill,  Irregular bleeding (70% in first year)  Increased risk of developing ovarian cysts  Increased risk of developing DM with past history of Gestational DM  Delay in ovulation and menses after stopping injections  Decreases HDL cholesterol  Weight gain  Depression  Drug interactions: Dilantin, Tegretol Carbatrol, Rifampicin, St. John’s Wort

39 Progestin-Only Injection

40 Depo Provera Medroxyprogesterone 150 mg IM every weeks Efficacy Rate:  Perfect Use=0.3 pregnancies / 100 women  Typical Use=<1 pregnancies / 100 women Mechanism:  Thickens cervical mucus  Blocks the LH/FSH surge  Slows tubal motility  Thins endometrial lining Initiate method:  First week of menses or  Quick Start if reasonably certain not pregnant Dickey RP (2010) Zieman M et.al. (

41 Contraceptive Injection  Decreased menstrual bleeding/ cramping  Improvement with endometriosis  Reduces risk of endometrial cancer  Reduces risk of ovarian cancer  Safe to use with blood clotting disorders  Good with seizure disorder  Effective for physically challenged  Decreases ectopic pregnancies  Breast feeding is not compromised  Private Irregular bleeding Amenorrhea Hypoestrogenism ▫Vaginal dryness ▫Acne ▫Hirsutism Return to fertility may be delayed No protection from STI Weight gain ▫Average of 5.4# in first year Bone mineral density effect ▫Calcium either diet or supplement ▫Weight bearing exercise ▫Avoid Cigarette use DisadvantagesAdvantages Zieman M, et al (2010)

42 Depo-Provera (medroxyprogesterone acetate injectable suspension Audience: Reproductive and other healthcare professionals FDA and Pfizer notified healthcare professionals of the addition of a BOXED WARNING along with revisions to the WARNINGS, INDICATIONS AND USAGE, PRECAUTIONS and POSTMARKETING EXPERIENCE sections of the prescribing information to include information on the loss of significant bone mineral density. Depo-Provera Contraceptive Injection is indicated only for the prevention of pregnancy in women of child-bearing potential. Bone loss is greater with increasing duration of use and may not be completely reversible. Depo-Provera Contraceptive should be used as a long-term birth control method (eg, longer than 2 years) only if other birth control methods are inadequate. [November 18, Dear Healthcare Professional Letter1 - Pfizer] [November 18, Dear Healthcare Organization Leader Letter2 - Pfizer] [November, Label3 - Pfizer]Dear Healthcare Professional LetterDear Healthcare Organization Leader LetterLabel

43 ACOG Committee Opinion Number 415, September 2008 Committee on Adolescent Health Care Committee on Gynecologic Practice “Conclusion Depot medroxyprogesterone acetate is a safe and effective means of long-term contraception, which has likely contributed to a decrease in adolescent pregnancy rates over the past decade. Concerns regarding the effect of DMPA on BMD should neither prevent practitioners from prescribing DMPA nor limit its use to 2 consecutive years. Appropriate counseling with a discussion of current medical evidence should occur before the initiation of this medication and during prolonged use. Practitioners should not perform BMD monitoring solely in response to DMPA use because any observed short-term loss in BMD associated with DMPA use may be recovered and is unlikely to place a woman at risk of fracture during use or in later years. Effective long-term contraceptive methods that have no effect on BMD and have high continuation rates, such as contraceptive implants and intrauterine devices, should also be considered as first-line methods for adolescents.”

44 Key Points: Injection First of the Long Acting Reversible Contraceptives Irregular bleeding is common side effect – counsel patients to expect Safe immediately postpartum Bone density reverts to normal after discontinuation of use ▫May safely use for longer than 2 years ▫Unnecessary to give supplemental estrogen ▫Bone Density Testing is not recommended Weight gain is a common side effect ▫Encourage daily exercise, calcium and vitamin D intake

45 Contraceptive Implant

46 NEXPLANON™ Single-rod implant (4 cm in length and 2 mm in diameter) made of ethylene vinyl acetate and contains 68 mg of etonogestrel ▫Initially progestin is released at rate of 60 mcg per day ▫Decreases to mcg/ day by end of first year  Efficacy Rate: ▫Perfect Use=0.3 pregnancies/ 100 women ▫Typical Use=0.3 pregnancies / 100 women Mechanism of Action: ▫Thickens cervical mucus ▫Inhibits ovulation ▫Atrophy of endometrium  Initiation of method:  Withinn 7 days of last menstrual period; no back up method needed  May insert anytime in the cycle, use backup for 7 days  MUST BE A CERTIFIED PROVIDER TO INTALL DEVISE  “Clinical Training Program for NEXPLANON” ideveloped by Merck Dickey RP (2010) Zieman M et.al. (

47 Contraceptive Implant Advantages Disadvantages  Active for three years  Estrogen-free  Safe in breast-feeding  Can be used in sickle-cell disease and seizure disorder  Patient does not have to take daily  Can be removed at any time  Rapid return of fertility  Inconspicuous  Serum levels of etonogestrel are detectable within hours of insertion  Irregular bleeding  No periods at all  Requires clinician visit for insertion and removal  Does not protect against sexually transmitted infections

48 Key Points: Implant Easy and quick to insert and remove Efficacy equivalent to sterilization Safe and rapidly reversible Irregular bleeding patterns may be a problem for some patients Majority of reproductive-age women are candidates, including adolescents Appropriate option for those preferring a long-term progestin-only method and do not want injections or an intrauterine device

49 Summary Progestin-only-contraceptives are safe and effective methods of contraception ▫Long –Acting-Reversible Contraception (LARC) ▫Orals require consistently timed ingestion of dose for maximum efficacy ▫Most common side effects are bleeding irregularities and weight gain ▫Very few contraindications for use—almost always a MEC 1 or 2 Progestin-only emergency contraception (Plan B One Step) is approved for over-the-counter sales to women over 15 years of age

50 Intrauterine Contraceptives

51 Mirena ® Levonorgestrel-Releasing Intrauterine System (LNG-IUS) Levonorgestrel 20 mcg releases every 24 hrs Efficacy Rate: ▫Perfect Use=0.3 pregnancies/ 100 women ▫Typical Use=0.3 pregnancies/ 100 women Mechanism of Action: ▫Thickens cervical mucus ▫Tubal fluid changes impair sperm & ovum migration ▫Suppresses endometrium ▫Inhibits ovulation Initiate method: ▫Insert within 7 days of LMP; no backup needed ▫Insert anytime in cycle and use backup method for 7 days Indicated for dysmenorrhea and heavy bleeding Endometrial protection during hormone or tamoxifen therapy Long-Acting Reversible Contraception Duration of use: 5 years

52 ParaGard® T380A Copper-Releasing Intrauterine Contraceptive Polyethylene device with 380 mm 3 of exposed copper Efficacy Rate: Perfect Use=0.8 pregnancies per 100 women Typical Use=3 pregnancies per 100 women Mechanism of Action: ▫Spermicide  Copper ions inhibit motility and viability of sperm  Inflammatory reaction of endometrium ▫Inhibition of implantation is a secondary mechanism Initiate Method: ▫Anytime in cycle; NO backup needed ▫May remove & insert in same visit ▫STI screening on day or insertion is acceptable Duration of use: 10 years Indicated for emergency contraception

53 Intrauterine Contraception Counseling Topics Effectiveness of intrauterine contraception Mechanism of action No protection against HIV or other sexually transmitted infections Noncontraceptive benefits Side effects ▫At insertion—variable pain, cramping, vasovagal reaction ▫First few days—light bleeding, mild cramping ▫First few months—intermenstrual bleeding, cramping  Copper IUD: Heavier or prolonged menses  LNG-IUS: Gradual decrease in menstrual flow Instructions on how to check the IUD string Return for follow-up appointment 4-6 weeks after placement

54 Intrauterine Contraception Advantages Disadvantages Highly effective birth control Long lasting No daily, weekly, monthly responsibility With Mirena, bleeding changes Weight neutral Cost effective May be used with nulliparous Painful to insert Possibility of perforation Possibility of expulsion Professional assistance to insert and remove Amenorrhea or Dysmenorrhea Ovarian cysts No protection against STI

55 Male and Female Barrier Contraceptives

56 Efficacy of Contraceptives Barrier Contraceptives Efficacy Male Condom 82% effective with typical use Female Condom During first year of use, 21% of women experience an unintended pregnancy Diaphram In 28-week multicenter randomized, parallel group study of unadjusted typical use, probability of pregnancy is 7.9% Spermicide Six- month probability of an unintended pregnancy is 10-22%, depending on dose and formulation Use of spermicidal in combination with another barrier method improves efficacy to using either alone Sponge 12- mo. cumulative life table pregnancy rate = 17.4% Parity affects failure rate: Nulliparous: 9% to 10% Parous: 19%- 21%

57 Male Condom Latex condom Polyurethane condom  Advantages  Highly effective against most STI’s  More resistant to breakage than polyurethane condoms  Disadvantages  Cannot be used if have latex allergy  Do not use with oil-based lubricants  Degraded by heat, light, and oxidation  Advantages  Safe to use with latex allergy  Thinner material than latex  Odorless/colorless  May  sensation of body heat during intercourse  Can be used with all lubricants  Disadvantages  Not as effective in protecting against STI’s as the latex condom  Expensive

58 Female Condom AdvantagesDisadvantages  Some protection against STI’s  No Rx required  Can be inserted up to 8 hrs before intercourse* should be removed shortly after  Made of polyurethane oMay not be as effective against pregnancy as the male condom oMust be inserted and removed by woman oAvailable in only one size oSingle use only oMay be noisy oOuter ring may be visually unappealing and uncomfortable *Division of Reproductive Health, National Center for Chronic Disease and Prevention and Health Promotion, 2013

59 Sponge AdvantagesDisadvantages  Made of latex-free material (polyurethane)  One size fits all  Does not require a prescription  Preloaded with nonoxynol-9 spermicide  Can be inserted up to 24 hours before intercourse  Can be left in place for up to 30 hours  Vaginal insertion and removal  Should remain in place for six hours after last intercourse  May increase risk of urinary tract infections and toxic shock syndrome  Not recommended for use more than once per day  Reduced efficacy among parous women

60 Spermicide AdvantagesDisadvantages  No prescription required  Increased lubrication during intercourse  VCF Film convenient and discreet  Some spermicides must be applied 10 to 15 minutes before initiation of intercourse  Must be reapplied every 1 to 2 hours  Do not protect against sexually transmitted infections  Increases risk for urinary tract infections  May cause irritation  May be messy or leak Effective Available as creams, gels, film, foam, and suppositories containing nonoxynol-9 Used alone or with a barrier method Available as creams, gels, film, foam, and suppositories containing nonoxynol-9 Used alone or with a barrier method

61 Diaphragm Advantages Disadvantages Can be inserted hours before intercourse Does not require removal between acts of intercourse Low Cost Some are made of rubber, a potential allergen Must be prescribed and fitted by a clinician Requires vaginal insertion and removal Spermicide must be reapplied before each act of intercourse Must be worn for at least 6 hours after last intercourse, but not more than 24 hours May increase risk of urinary tract infections and toxic shock syndrome Used with a spermicide

62 Key Points: Barrier Methods A number of prescription-only and over-the-counter barrier methods are available Some methods provide protection against sexually-transmitted infections Barrier methods are less effective than hormonal methods Devices must be placed before coitus, reducing spontaneity May require cooperation of partner Nonoxynol-9 does not prevent sexually transmitted infections but does kill sperm

63 Natural Contraceptive Methods

64 Efficacy of Contraceptives Natural Contraceptives Efficacy Abstinence Perfect Use: 1-9/ 100; Typical Use= 20 pregnancies/ 100 women Breastfeeding/ LAM (Lactational Amenorrhea Method) Perfect use: 2/100 Typical use: 5/100 women will get pregnant Effectiveness rates only apply to women who are exclusively breastfeeding for the first 6 months postpartum. Fertility Awareness Perfect Use = 1-9/ 100 Typical Use=12-25/100 women Best if combine Basal Body Temperature/ Calendar/ Cervical Mucus Methods Coitus Interruptus “Withdrawal” Perfect Use=4/100; Typical Use=27/pregnancies / 100 women ZiemznM, et al (2010) Samra-Laff OM & Wood E (2009) Stacy,D (2012)

65 Lactational Amenorrhea Method (LAM) Mechanisms of Action Irregular secretion of GnRH interferes with release of follicle stimulating hormone (FSH) and luteinizing hormone (LH) Frequent intense suckling disrupts secretion of gonadotrophin releasing hormone (GnRH) Decreased FSH and LH disrupts follicular development in the ovary to suppress ovulation

66 LAM: Benefits vs. Limitations BenefitsLimitations Effective (1-2 pregnancies per 100 women during first 6 months of use) Effective immediately Does not interfere with sexual intercourse No systemic side effects No medical supervision necessary No supplies required No cost involved User-dependent (requires following instructions regarding breastfeeding practices) May be difficult to practice due to social circumstances Highly effective only until menses return or up to 6 months Does not protect against STDs (e.g., HBV, HIV/AIDS)

67 Methods of Fertility Awareness/NFP Calendar/Standard Days Basal Body Temperature (BBT) Cervical Mucus (Billings) Symptothermal (BBT + cervical mucus)

68 Natural Family Planning (NFP) Mechanism of Action Conditions Requiring Precaution For contraception: ▫Avoid intercourse during the fertile phase of the menstrual cycle when conception is most likely. For conception: ▫Plan intercourse near mid-cycle (usually days 10-15) when conception is most likely. Irregular menses Persistent vaginal discharge Breastfeeding

69 Natural Family Planning (NFP BenefitsLimitations Can be used to prevent or achieve pregnancy No method-related health risks No systemic side effects Inexpensive Requires daily record keeping Vaginal infections make cervical mucus difficult to interpret Basal thermometer needed for some methods Does not protect against STDs (e.g., HBV, HIV/AIDS)

70 Withdrawal BenefitsLimitations Effective immediately Does not affect breastfeeding Can be used as backup to other methods No method-related health risks Always available No cost involved Effectiveness depends on willingness of couple to use method with every act of intercourse Effectiveness may be further decreased by sperm from a recent (< 24 hours) ejaculation remaining in the penis (urethra) May diminish sexual pleasure Does not protect against STDs (e.g., HBV, HIV/AIDS) A traditional method of family planning in which the man completely removes his penis from the woman’s vagina before he ejaculates Sperm do not enter the vagina and fertilization is preve nted

71 Abstinence Mechanism ▫excludes sperm from female reproductive tract Effectiveness ▫0% failure rate Complications ▫recent data have shown an increase in teen sexual activity and pregnancy if no education is given on contraception Ideal for adolescents at high risk for pregnancy and STD’s including HIV Ideal for adolescents at high risk for pregnancy and STD’s including HIV

72 Sterilization Methods

73 Female Sterilization: Mechanism of Action By blocking the fallopian tubes (tying and cutting, rings, clips or electrocautery), sperm are prevented from reaching ova and causing fertilization.

74 Non-Surgical Tubal Occlusion  Brand name: Essure® Tubal sterilization through hysteroscopic placement of micro-coil in fallopian tubes

75 Sterilization AdvantagesDisadvantages Ideal for those desiring no more children Quick recovery Lack of significant long-term effects Cost-effective No need to remember to use contraception before intercourse No need for partner compliance High degree of safety; low mortality rates Permanence ▫Reversal is expensive, requires major surgery, and is not guaranteed Regret for the decision Expense at time of procedure Procedure requires aseptic conditions, surgical equipment, trained clinicians, and anesthesia Does not protect against HIV or other sexually transmitted infections

76 Mechanism of Action: ▫Blocks vas deferens (ejaculatory duct) ▫Sperm are not present in the ejaculate Types ▫No-scalpel technique (preferred) ▫Incisional Male Sterilization: Vasectomy

77 Sterilization: Counseling Guidelines Discuss other contraceptive options, that in addition to sterilization, provide effective long-term protection from pregnancy ▫Side effects, risks ▫Suitability for the patient ▫Failure rates, stressing that no contraceptive method is 100% effective ▫Recovery ▫Permanence and potential for reversibility Allow sufficient time between patient counseling, decision making, and the sterilization procedure to ensure a thoughtful and informed decision (especially for patients considering a postpartum or postabortion sterilization ) 30 days is required by law for patients with Federally subsided insurance.

78 Sterilization: Legal and Ethical Issues Informed consent Spousal/partner consent is not required For federally funded sterilizations, the patient must: ▫be at least 21 years of age ▫be mentally competent ▫wait 30 days after signing an informed consent form before undergoing the sterilization procedure

79 What If…? …the condom broke or slipped off... …you forgot your regular birth control... …you were forced to have sex...

80 Emergency Contraception Levonorgestrel products inhibit ovulation Ulipristal inhibits follicular rupture Paragard used as EC inhibits implantation Best if used within 72 hours of unprotected intercourse  Plan B- One Step (Levonorgestrel 1.5 mg) ▫One time dose ▫Over-the-Counter  Ella (Ulipristal Acetate 30 mg) ▫One time dose ▫Prescription only  Paragard (Cu T380) ▫Inserted up to 5 days after unprotected intercourse ▫Is most effective EC but least used ▫Trussell J; Raymond EG; Cleland K (2014)

81 Choosing Contraceptives

82 Patient Needs & Concerns: “ How important is it to avoid pregnancy right now?” “Do you want your use of contraception to be private?” “Do you have concerns about a particular contraceptive?” “What side effects are you willing to accept?” “What methods have you used in the past?” “Do you have new health issues?”

83 Hormonal Contraceptives: Coexisting Medical Conditions

84 CDC United States Medical Eligibility Criteria for Contraceptive Use (US MEC) MEC 1: Can use. No restriction. MEC 2: Can use with closer medical supervision MEC 3: Should not use.  Method of last choice with regular monitoring. MEC 4: Should not use.  Unacceptable health risk.

85 US MEC with Certain Medical Conditions Medical Conditions TCu-380A CHC POC Hypertension (controlled=140/90) 132 History of DVT or pulmonary embolism 142 Varicose veins 121 Stroke 142 Severe valvular heart disease (complicated)242 HIV infection 211 AIDS (clinically well on antiretroviral therapy) 2 Check drug interactions 2 Headaches-migraine with aura 142 Postpartum not breast feeding < 21 days 13/42 Smoker > 35 y/o 141 US Medical Eligibility Criteria for Contraceptive Use. 2010

86 Cardiovascular Disease: Conditions that increase risk of CVD Diabetes HTN Thrombophilias Obesity Migraine headaches Immbolization Valvular Disease

87 Diabetes YESDO NOT LIMIT USE OF CHC CHCs do not significantly affect glycemic control CHCs do not accelerate diabetic vascular disease CHCs do not precipitate the risk of developing DM  Non-SMOKERS  Otherwise healthy:  ø HTN  ø nephropathy  ø neuropathy  ø vascular disease Are combination hormonal contraceptives (CHC) safe for women with diabetes?

88 Headache Migraine w/ AuraMigraine Visual disturbance in both eyes Unilateral numbness Flashing or moving scotoma "Pins & needles" in extremities Unilateral weakness Aphasia or other speech difficulties Nausea/ Vomiting Photophobia Watery Eyes Taste or smell sensations What kind of HEADACHE is it?

89 What to prescribe with Headaches? Condition COC + Patch & Ring Depo-Provera Mirena Implanon Progestin-only pills Non-migraine headaches 1/211 Migraine w/o aura, age <35 2/321/2 Migraine w/o aura, age >35 3/421/2 Migraine with aura, any age 42/3 U.S Medical Eligibility Criteria for Contraception. 2010

90 Postpartum and Breastfeeding CHC Progestin Implant DMPACu-IUD LNG- IUS Breastfeeding < 6 weeks PP 433**  6 weeks to 6 months PP Postpartum < 21 days wks11133 > 4 wks11111 * See below.

91 Seizure Disorders Anticonvulsants that decrease serum steroid levels ▫ Barbiturates (including Phenobarbital and primidone [Mysoline] ▫ Carbamazepine (Tegretol) and oxcarbazepine (Trileptal) ▫ Felbamate (Felbatol) ▫ Phenytoin (Dilantin) ▫ Topiramate (Topamax Anticonvulsants that do not decrease serum steroid levels Gabapentin (Neurontin) Lamotrigine (Lamictal) Levetiracetam (Keppra) Tiagabine (Gabitril) Valproic acid (Depakene) Zonisamide (Zonegran) Interactions Between Anticonvulsants and Combination Contraceptives

92 Contraceptive Compliance Improving Contraceptive Compliance

93 Contraceptive Counseling Start visit with discussion of future fertility plans ▫What are your childbearing plans? Discuss the patient’s preferences ▫What has worked for you before? ▫What is your partner’s preference? Consider patient’s medical history ▫Choose contraceptive for both safety and efficacy

94 Quick Start Method

95

96 Patient Follow-up Schedule a recheck visit Ask:  Are you satisfied with your contraceptive method?  Is there anything you would change?  Are you having bleeding problems or other side effects?

97 Missed Pills (combined OCs) Action Advised <12 hrs (late for dose) hrs (missed 1 pill) >24 hrs (missed 2 pills) >48 hrs (>2 pills missed) Take Missed dose ASAP Yes 1,2 Yes Take “make-up” dose NA 1,2 Yes 1,2 Yes 1 No 2 No Use backup contraception No 1,2 No 1 Yes – 7 days 2 Yes – 7 days 1,2 Begin next cycleNo change In wk 3 -- begin day 22

98 “A-C-H-E-S” A bdominal pain (severe) C hest pain (severe, cough, SOB, sharp pain on inhaling H eadache (severe) or if accompanied by dizziness, weakness, or numbness, especially if one-sided E ye problems (vision loss or blurring) or speech problems S evere leg pain (in calf or thigh)

99 Drug Interactions and OC AgentMechanism Action Recommended Antibiotics (broad spectrum) penicillins, teracyclines. Griseofulvin Alteration of the steroid gut metabolism due to changes in the intestinal flora Use of an alternative or back- up method during antibiotic therapy is recommended. Acitretin (soratane)Mechanism unknown. Reduces the efficacy of progestin only pills. Unknown if interaction is seen with COC. Use alternative or additional form of contraception.

100 Drug Interactions and OC (cont) AgentMechanism Action Recommended Anticonvulsants (phenytion, carbamazepine, phenobarbital, primidone) Cytochrome P450 interaction (CYP3A4 induction) Use higher estrogen formulations or an alternative method or a secondary method Rifamycins (rifabutin, rifampin, rifapentine) Cytochrome P450 interaction (CYP3A4 induction) Non-hormonal contraception during therapy and for one cycle after treatment ends. Using a higher dose estrogen formulation is possible but less desirable.

101 Drug Interactions and OC (cont) AgentMechanism Action Recommended Antiviral protease inhibitors Cytochrome P450 interaction (CYP3A4 induction) Use higher estrogen formulations or an alternative/secondary method BenzodiazepinesMetabolism of agents that undergo oxidation may be decreased resulting in increased benzodiazepam effects. May need to lower doses of benzodiazepines if CNS symptoms occur.

102 Drug Interactions and OC (cont) AgentMechanism Action Recommended Specific hypoglycemicsDecreased contraceptive effect Use an alternative method or as a secondary method. Ascorbic acid (Vitamin C doses of 1 gm or more daily) Increased concentration of estrogen with possible increase in side effect. Avoid high doses of Vitamin C. Use low doses of estrogen.

103 “ For most women, including women who want to have children, contraception is not an option; it is a basic health care necessity. ” For most women, including women who want to have children, contraception is not an option; it is a basic health care necessity. Representative Louise Slaughter, US Congresswoman, New YorkLouise Slaughter


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