Evidence Based Contraception

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1 Evidence Based Contraception Susan Hellier PhD, DNP, FNP-BC, CNE Since I ve Got the Pill You wined me and dined me When I was your girl Promised if I'd be your wife You'd show me the world But all I've seen of this old world Is a bed and a doctor bill I'm tearin' down your brooder house 'Cause now I've got the pill Learning Objectives 1. Be able to utilize the US MEC to help make evidence based contraceptive decisions for patients with complicating medical conditions 2. Understand current screening guidelines 3. Learn some contraceptive history which may be useful if you are a contestant on Jeopardy and the category is Contraception through the Ages

2 Do You Use the US MEC in Your Practice? A. Every day (or more often) B. Occasionally (a few times a week) C. Rarely (a few times a month) D. Never they don t apply to my practice E. I ve never heard of them! WHO Medical Eligibility Criteria for Contraceptive Use 4th edition contraception/who_chart.htm Purpose: who can safely use contraceptive methods

3 Obstet Gynecol September 2011; 118:754 ACOG endorses the USMEC and encourages its use these recommendations are meant to be a source of clinical guidance; providers should always consider the individual clinical circumstances of each person seeking family planning services WHO/US Medical Eligibility Criteria Categ Definition 1 No restriction in contraceptive use Recommendation Use the method

4 WHO/US Medical Eligibility Criteria Categ Definition 1 No restriction in contraceptive use 2 Advantages generally outweigh theoretical or proven risks Recommendation Use the method More than usual follow up needed WHO/US Medical Eligibility Criteria Categ Definition 1 No restriction in contraceptive use 2 Advantages generally outweigh theoretical or proven risks 3 Theoretical or proven risks outweigh advantages Recommendation Use the method More than usual follow up needed Clinical judgment that the patient can use safely WHO/US Medical Eligibility Criteria Categ Definition 1 No restriction in contraceptive use 2 Advantages generally outweigh theoretical or proven risks 3 Theoretical or proven risks outweigh advantages 4 Unacceptable health risk if the method is used Recommendation Use the method More than usual follow up needed Clinical judgment that the patient can use safely Do not use the method

5 What does the CHC and Susan Hellier have in common? We both have less estrogen then we used to have. Case Study: Headaches Ms. K is a married 22 year old G 2 P 0 TAB 2 woman who requests a prescription for OCs Her first two pregnancies were at 17 and 19 years old and occurred while using condoms She stated that she has occasional sick headaches Recently, 2 episodes were so severe that she left work

6 Tension Headache Most common headache: 59% of reproductive aged women Diagnosis Lasts for 30 minutes 7 days At least two of Bilateral location Pressing/tightening in neck, scalp; non pulsating Mild moderate intensity Not made worse by physical activity Both of No nausea/vomiting No more than 1 of photophobia, phonophobia International Headache Society (IHS) Tension Headache Improved with sleep, analgesics, relaxation Not associated with increased stroke risk No effects of menstrual cycles or exogenous hormones on frequency or severity of headaches International Headache Society (IHS) Migraine Headache Without Aura aka: common or simple migraine Attacks last 4 72 hours (untreated or unsuccessful) At least 2 of the following Unilateral or bilateral temporal pain Pulsating (throbbing) quality Moderate or severe pain intensity Aggravated by routine physical activity At least 1 of the following during the attack Nausea, vomiting Phonophobia (sound) and photophobia (light) Not attributed to another disorder International Headache Society (IHS)

7 Migraine Headache With Aura aka: complex or classic migraine A. Meets criteria for migraine, and >2 attacks with B D B. Aura, with at least one fully reversible finding Visual flickering lights, spots, lines or loss of vision Flashing zig zag line from center of visual field to periphery Sensory: pins and needles and/or numbness Dysphasic speech disturbance International Headache Society (IHS) Migraine Headache With Aura (continued) C. At least 2 other characteristics Visual symptoms or unilateral sensory sxs At least 1 aura symptom develops over >5 mins Each symptom lasts >5 mins and < 60 minutes D. Headache develops during the aura or follows <60 min Aura without headache = opthalmic migraine E. Not attributed to another disorder International Headache Society (IHS) Migraine Headache: Complications Migraine is an independent risk factor for stroke An increased relative risk A low absolute risk, incidence rate of 5 11 strokes per 100,000 women per year Condition Odds ratio No migraine or COCs or smoking 1.0 Migraine without aura 1.8 Migraine with aura 2 4 Migraine + COCs 6 14 Migraine with smoking 7 10 Migraine + smoking + OC 34.4 Edlow AG, Bartz D. Rev in Obstet Gynecol, 2010; 3(2): 55-65

8 US MEC 2010: Headaches Non Migrainous OC/P/R POP DMPA Impl LNG I C Cu Migraine I C I C I C Without aura Age < Age > I: Initiate C: Continue OC/P/R POP DMPA Impl LNG Cu Nonmigrainous US MEC 2010: Headaches Migraine I C I C I C Without aura Age < Age > I: Initiate C: Continue Nonmigrainous US MEC 2010: Headaches OC/P/R POP DMPA Impl LNG I C Cu Migraine I C I C I C Without aura Age < Age > With aura Any age I: Initiate C: Continue

9 Headaches and Contraception: Management Migraine, esp migraine with aura is associated with an increased risk in ischemic stroke Differentiate migraine from non migraine headaches If unclear, seek neurologist consultation CHC in women with migraines without aura Use low estrogen dose product Recommend frequent follow up visits initially If HA worsening frequency or severity, or new neurological symptoms, discontinue OC/patch/ring Progestin only methods, s are safe and effective Menstrual Migraine A subset of migraine Menstrual headaches: extended regimen OCs or NuvaRing NSAIDS, triptans more effective than placebo Estrogen Withdraw Headache Reduce the hormone free interval or eliminate

10 Case Study: Type 2 Diabetes 33 year old G 3 P 3 woman with gestational diabetes diagnosed in 2nd pregnancy No insulin between 2nd 3rd pregnancies, required insulin during 3 rd pregnancy ended 2 years ago Now on metformin for type 2 diabetes; considering switch to insulin due to poor control Would like to use a hormonal method of contraception, if possible Diabetes and Contraception Progestins may increase insulin resistance, but not to the point of clinically significant blood glucose Estrogen increases risk of thrombosis in vessels damaged by diabetic vascular disease CHC may be used in diabetics in the absence of clinicallymanifest vascular disease, including Retinopathy, nephropathy Peripheral vascular disease, heart disease

11 US MEC 2010: Diabetes History of gestational diabetes OC/P/R POP DMPA Impl LNG Cu US MEC 2010: Diabetes OC/P/R POP DMPA Impl LNG Cu History of gestational diabetes DM: Nonvascular disease i. Noninsulin dependent ii. Insulin dependent US MEC 2010: Diabetes OC/P/R POP DMPA Impl LNG Cu History of gestational diabetes DM: Nonvascular disease i. Noninsulin dependent ii. Insulin dependent Nephropathy/retinopathy/ neuropathy 3/

12 US MEC 2010: Diabetes OC/P/R POP DMPA Impl LNG Cu History of gestational diabetes DM: Nonvascular disease i. Noninsulin dependent ii. Insulin dependent Nephropathy/retinopathy/ 3/ neuropathy Other vascular disease or diabetes of >20 yrs duration 3/ Diabetes and Contraception: Management Adjust insulin or oral hypoglycemic as necessary Combined hormonal contraceptives Evaluate CV risk profile: age, smoking, HTN, lipids Use low E (thrombosis) + low P (glucose control) Progestin only methods May cause insulin resistance and blood glucose, but usually clinically insignificant Do not increase risk of arterial thrombosis s are a safe and effective choice Discuss preconception care with all diabetic women The condom Dr Condom (or Conton) personal physician to King Charles II Violet Crumble wrapper misuse

13 Case Study: Breast Lump in OC User 41 year old G 2 P 2 lawyer using OC's for 9 years Regular withdrawal bleeds; wants to continue Past history is unremarkable Breasts nodular; 3 x 3 cm "prominence" R UOQ No fixation; no nipple discharge At breast clinic, told that biopsy not needed Plan to "observe" over the next 3 months "Up to the her provider" to decide whether to continue on OC's Breast Disease: US MEC 2010 Undiagnosed breast mass OC/ POP DMPA Impplant LNG Cu P/R IUS Breast Disease: US MEC 2010 Undiagnosed breast mass Family history of breast cancer OC/ P/R POP DMPA Impplant LNG IUS Cu

14 Breast Disease: US MEC 2010 OC/ P/R POP DMPA Impplant LNG IUS Cu Undiagnosed breast mass Family history of breast cancer Benign breast disease Breast Disease: US MEC 2010 OC/ P/R POP DMPA Impplant LNG IUS Cu Undiagnosed breast mass Family history of breast cancer Benign breast disease Breast cancer; current Breast Disease: US MEC 2010 OC/ P/R POP DMPA Impplant LNG IUS Cu Undiagnosed breast mass Family history of breast cancer Benign breast disease Breast cancer; current Past breast cancer (no evidence of current disease for 5 years)

15 Contraception in a Woman with a Breast Mass Women with (biopsy proven) fibroadenoma may use hormonal contraceptive methods CHC users with abnormal breast findings Guidelines recommend continuation of CHC until diagnosis is made; inform client of risks/ benefits Contraception in a Woman with a Breast Mass Based on US MEC criteria (category 2), continue OCs during observation period Given age & findings, order diagnostic mammogram Management plan explained to the patient she was willing to follow this plan Reference algorithms for breast abnormalities ml#booklet

16 Case Study: Obese Adolescent 19 year old G 0 woman is seen for a periodic health screening visit (aka, a Well Woman visit) In monogamous relationship for the past year Feeling well; no complaint of vaginal discharge, abnormal bleeding, dyspareunia Weight: 210 lbs; BMI: 32 kg/m 2 Using contraceptive patch; asks about use of DMPA Questions Which methods are best relative to her BMI and age? What needs to be done at her check up visit? Do you require a pelvic exam for CHCs? A. Always B. Sometimes C. Usually D. Never Henderson JT et al Obstet Gynecol 2010;116:1257 6

17 Check Up Visit: 19 Year Old Female Clinical breast exam Pap smear Bimanual pelvic exam Chlamydia NAAT Gonorrhea NAAT HIV 1 serology HSV 2 serology Syphilis (VDRL or RPR) Hepatitis B serology HPV test (Hybrid Capture) Check Up Visit: 19 Year Old Female Clinical breast exam Pap smear Bimanual pelvic exam Chlamydia NAAT Gonorrhea NAAT HIV 1 serology HSV 2 serology Syphilis (VDRL or RPR) Hepatitis B serology HPV test (Hybrid Capture) Routine Pelvic Examination and Cervical Cytology Screening ACOG Comm on Gyn Practice, #431. OG 2009; 113:1190 The annual pelvic exam Is not a routine part of annual assessment for women yo, unless medically indicated Is a routine part of preventive care for women 21 yo or older, even if cytology is not needed No justification or evidence offered

18 Is A Screening Pelvic Exam Necessary in Adolescents? In sexually active asymptomatic women under 21, physical assessment at screening visits should consist of Blood pressure check, BMI, and PNP PNP= Pee, not Pap, self collected vaginal swabs STD Chlamydia NAAT, GC NAAT Pelvic exam: not until 21 years old Pap: not until 21 years old With or without a contraceptive prescription Body Weight and Contraception Four issues about body weight relate to each method Will the method cause excess weight gain? Is the failure rate higher in obese women? Are there medical risks attributable to the method in obese women (compared average weight)? What is the US MEC category and why? Pregnancy and childbirth among obese women are far more dangerous than are either contraception or sterilization Body Weight and Contraception OC Patch DMPA Implant Tubal Weight gain No No Yes* No No No * Mainly in obese adolescents and those who experience a >5% body weight increase within 6 months of DMPA initiation

19 Body Weight and Contraception OC Patch DMPA Implant Tubal Weight gain No No Yes* No No No failure rate in obese No Yes # No No No No # If weight > 90 kg, increase of 2 4 failures/ 100 couples/year OC Patch DMPA Implant Tubal Weight gain No No Yes* No No No failure rate in obese Medical risk in obese women Body Weight and Contraception No Yes # No No No No DVT risk DVT risk None None Difficult insertion Surgical complications OC Patch DMPA Implant Tubal Weight gain No No Yes* No No No failure rate in obese Medical risk in obese women Body Weight and Contraception No Yes # No No No No DVT risk DVT risk None None Difficult insertion Surgical complications US-MEC 2 2 1/2 ** 1 1 Not rated ** < 18 yrs of age and 30 kg/m 2 BMI

20 Obese Adolescent and Contraception: Management DMPA is not an ideal choice for her because of the potential for additional weight gain If DMPA chosen, obtain a baseline weight and recheck in 6 months All methods work as well in obese women as with average weight women, except the contraceptive patch The efficacy of emergency contraceptive pills is poor in obese women s and implants are an excellent choice for adolescents, obese women, and obese adolescents Why LARC* Methods? *Long Acting Reversible Contraception s and Implants are forgettable Single motivational act for insertion Do not require episodic, daily, weekly, monthly, or every 12 week user initiative No need to take time to refill prescriptions or risk that prescriptions will not be refilled on time Give continuous 24/7/365 contraceptive protection Provide long term protection 3 10 years

21 Why LARC* Methods? *Long Acting Reversible Contraception Are the most effective reversible methods available Are among the safest contraceptive methods very few US MEC category 3 or 4 grades Have superior continuation rates and highest patient satisfaction among methods Are an alternative to surgical sterilization Are the most cost effective and cost saving methods US MEC: Age and Parity OC/ P/R POP DMPA Implant LNG IUS Cu <40 yo 1 <40 yo 1 <18 yo 2 <18 yo 1 <20 yo 2 <20 yo 2 >40 yo: 2 >40 yo: yo yo 1 >20 yo 1 >20 yo 1 >45 yo 2 >45 yo 1 Nullip Parous

22 Early Contraception Alligator/elephant Dung 3,000 yrs ago Centuries ago women drank lead/mercury Hippocrates Queen Anne s lace seeds Barbasco Root Russell Marker Anticonvulsant Therapy: US MEC 2010 OC/ P/R POP DM PA Impplant LNG IUS Cu Epilepsy (no treatment) Anticonvulsant therapy a. Certain anticonvulsants (phenytoin dilantin, carbamazepinetegretol, barbituates, primidone, topiramate topamax, oxcarbazepine) b. lamotrigine Lamictal*,# 3/ * The #3 with Lamictal applies only when used as monotherapy, If combined with a nonenzeme- inducing antiepileptic drug--- becomes a #1. # use of Lamictal levels decrease significantly Contraceptive Management with Pts on anti convulsant medications Evidence: Use of certain anticonvulsants might decrease the effectiveness of COCs, but still better than barrier methods Use of other contraceptives should be encouraged for women who are long term users of any of these drugs. When a COC is chosen, a preparation containing a minimum of 30 µg EE should be used.

23 First sperm Seen 1677 Anthony van Leeuwenhoek CHC and Antibiotics Evidence Based Rifampin is the only antibiotic proven to decrease serum ethinyl estradiol and progestin levels in women History of bariatric surgery Restrictive procedures Malabsorptive procedures COC P/R POP DMPA Implant LNG Cu-

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