Choosing a Birth Control Method SNAP, 2014

Learning Objectives At the conclusion of this program, participants will be able to: Describe contraceptives currently available in the U.S. Discuss pros, cons, and efficacy of appropriate methods with patients Provide evidence-based contraceptive care Practice effective strategies to achieve patients’ contraceptive success Develop individualized strategies for provision of contraception to patients

Unintended Pregnancy in the US Finer LB. Contraception. 2011; Finer LB. Fertil Steril. 2012; Finer LB. Perspect Sex Reprod Health. 2006; Henshaw SK. Fam Plann Perspect Unintended 49% Unintended births Elective abortions Fetal losses Intended: 51% 51% 23% 21% 5% 6.7 MILLION PREGNANCIES over one year

Goals to Address Unintended Pregnancy Healthy People 2020 ▪ Increase proportion of pregnancies that are intended ▫51%  56% ▪ Reduce proportion of females experiencing pregnancy despite reversible contraception use ▫12.4%  9.9% CDC Winnable Battles ▪ Public health priorities with large-scale impact on health and with known, effective strategies to intervene ▪ To identify optimal strategies and to rally resources and partnerships to accelerate a measurable impact on health ▪ Prevention of teen pregnancy is one of the 6 winnable battles

Contraception Use Mosher, W et al

Improving Contraception Access Improve access to and use of the most effective contraceptives Address barriers to use of Long Acting Reversible Contraceptives (LARC) Educate Providers ▪ Ensure dissemination of US MEC ▪ Recommend that young women and nulliparous may be eligible to use LARC methods Increase interest and acceptance through education and social marketing Address cost barriers to ensure publically funded services include LARC

US Medical Eligibility Criteria for Contraceptive Use

Current Contraceptive Options Extremely effective Effective >99% of the time Male/Female Sterilization IUD/IUS Implants Very effective Effective >92% of the time Pills Injectables Patch Ring Moderately effective Effective ~80% of the time Male/Female Condom Withdrawal Sponge Diaphragm Effective Effective up to 75% of the time Fertility Awareness Cervical cap Spermicide

Polling Question Which contraceptive method do you most often recommend to your patients?

Typical Effectiveness of Contraception Adapted from: WHO. Family Planning: A Global Handbook Long acting reversible contraceptives (LARCs) Tier 1 Tier 2 Tier 4 Tier 3

Case Study: Gwen Age: 43 Uses OCs Has two children Does not desire more children What would you recommend?

Standard of care = no-scalpel vasectomy (NSV) ▪ Small (few mms) opening is made in the scrotal sac skin to deliver vas deferens ▪ Ligate/cauterize ▪ No scalpel ▪ No sutures Extremely Effective Male Sterilization Hillis SD. Obstet Gynecol The New York Times Nirapathpongporn A. The Lancet Peterson H. U.S. Collaborative Review of Sterilization Pollack AE. Contraceptive Technology Trussel J. Contraceptive Technology

Ligating Blocking (clips or rings) Cauterizing Peterson H. U.S. Collaborative Review of Sterilization Hillis SD. Obstet Gynecol Pollack AE. Contraceptive Technology Ogburn T. Obstet Gynecol Clin North Am et al. Female Sterilization: Surgical Tubal Occlusion Sterilization Regret Extremely Effective

Brand name: Essure ® Micro-inserts placed into proximal fallopian tubes 99.83% effective Choosing Essure Pollack AE. Contraceptive Technology Ogburn T. Obstet Gynecol Clin North Am et al. Female Sterilization: Nonsurgical Tubal Occlusion Extremely Effective

Levonorgestrel Intrauterine System (LNG 52 IUS) Brand name: Mirena ® 20 mcg levonorgestrel/day Approved for 5 years of use Amenorrhea in ~20% of users by 1 year Mirena Prescribing Information : Trussel J. Contraceptive Technology. 2011; Hidalgo M. Contraception Extremely Effective

Levonorgestrel Intrauterine System (LNG 13.5 IUS) Brand name: Skyla ® 14 mcg levonorgestrel/day Approved for 3 years of use Amenorrhea in ~6% of users by 1 year Skyla Prescribing Information Trussel J. Contraceptive Technology Extremely Effective

Brand name: ParaGard ® Copper ions Approved for 10 years of use Can be used as emergency contraceptive Thonneau, PF. Am J Obstet Gynecol Forrtney JA. J Reprod Med Trussel J. Contraceptive Technology Copper-T IUD Extremely Effective

Characteristics of Intrauterine Contraception Very high patient satisfaction Rapid return of fertility Safe Long-term protection Highly effective May be inserted after delivery or abortion Belhadj H, et al. Contraception ; Skjeldestad F, et al. Advances in Contraception ; Arumugam K, et al. Med Sci Res ; Tadesse E. Easr Afr Med J Extremely Effective

Choosing Appropriate Intrauterine Contraception Extremely Effective LNG 13.5, LNG 52 IUS Amenorrhea acceptable Irregular bleeding tolerable History of dysmenorrhea (LNG 52 IUS) History of menorrhagia (LNG 52 IUS) Copper-T IUD Wants regular menses Does not want hormones No history of dysmenorrhea No history of menorrhagia

Can be used: in women with multiple partners in women with history of STDs or PID in nulliparous women in teens immediately postpartum immediately post-abortion in women with past ectopic pregnancy Extremely Effective Dispelling Myths about Intrauterine Contraception MacIsaac L. Obstet Gynecol Clin N Am Toma A. Pediatr Adolesc Gynecol Otero-Flores JB. Contraception Suhonen S. Contraception WHO

Intrauterine Contraception and Fertility Hubacher D, et al. NEJM Extremely Effective IUD use not associated with infertility (OR=0.9) Chlamydia associated with infertility (OR=2.4) Results confirmed by similar studies ~2000 women enrolled in case-control study

Case Study: Nell Age: 32 Has one child Wants another in a few years Uses OCs but not consistently What would you recommend?

Implant Brand name: Nexplanon ® Contains etonogestrel Effective for 3 years Trussell J, et al. In: Hatcher RA, et al., eds Contraceptive Technology, 20 th Revised Edition NEXPLANON [package insert]. Whitehouse, NJ: N.V. Organon, Oss; 2012 Extremely Effective

Timing of IUD/IUS/Implant Insertion Alvarez PJ. Ginecol Obstet Mex O’Hanley K, et al. Contraception Extremely Effective Anytime during menstrual cycle when pregnancy can be excluded (confirmed by negative pregnancy test and no report of unprotected sex in past two weeks)

Typical Effectiveness of Contraception Adapted from: WHO. Family Planning: A Global Handbook Long acting reversible contraceptives (LARCs) Tier 1 Tier 2 Tier 4 Tier 3

Case Study: Johanna Age: 35 Smoker (half pack/day) Recently divorced and dating Uses OCs successfully OCs help her headaches What would you recommend?

Combined Oral Contraceptives Contain estrogen & progestin Most newer formulations contain 20 – 35 mcg of ethinyl estradiol + 1 of 8 available progestins Trussel J. Contraceptive Technology Rosenberg MJ. Reprod Med Potter L. Fam Plann Perspect Mosher WD. AdvanceData Hardman JG. McGraw-Hill Goldzieher JW. Fertil Steril Moghissi KS. Fertil Steril Very Effective

Progestin-Only Oral Contraceptives Called the “mini-pill” Two formulations: norethindrone & norgestrel No placebo week Timing of pill-taking is crucial Apgar BS. AFP WHO MEC Contraception Report Apgar BS. AFP et al. Very Effective

Extended Hormonal Contraception Delays or eliminates menstruation Menstrual and nonmenstrual benefits Extended methods: Continuous use of COCs, transdermal patch & vaginal ring Seasonale ®, Seasonique ®, Quartette™ & Lybrel ®, - dedicated extended OC regimen Anderson FD. Contraception Kaunitz AM. Contraception ARHP NuvaRing Product Information Stewart FH. Obstet Gynecol Kwiecien M. Contraception Sulak PJ. Am J Obstet Gynecol Very Effective

Extended/Continuous COC Options: Dedicated Products Seasonale ® 84 days active pills (30mcg EE + 150mcg LNG) 7 days inactive placebo pills Seasonique ® 84 days active pills (30mcg EE + 150mcg LNG) 7 days low- dose estrogen pills Lybrel ® Full year of continuous active pills (20mcg EE + 90mcg LNG ) Quartette TM 42 days: 20mcg EE + 150mcg LNG 21 days: 25mcg EE mcg LNG 21 days: 30mcg EE mcg LNG 7 days: 10mcg EE Anderson et al. 2003; Stewart et al. 2005; Portman

Age: 14 May be ready for sex No current contraceptive method Case Study: Brianna What would you recommend?

Brand name: OrthoEvra ® Beige-colored patch applied once/week 3 weeks on, 1 week off 9 days of medication in each patch Abrams LS. Fertil Steril Ortho Evra Prescribing Information. Archer DF. Fertil Steril Zacur HA, et al. Fertil Steril Zieman M. Fertil Steril Archer DF. Contraception Audet MC. JAMA Transdermal Patch Very Effective

Vaginal Ring Brand name: NuvaRing ® Flexible, unfitted ring placed in vagina In 3 weeks/out 1 week 4 weeks of medication in ring Continuous use: change once every 4 weeks NuvaRing Prescribing Information. Organon. 2001: Timmer CJ. Clin Pharmacokinet Herndon EJ. Am Fam Physician. 2004: Dieben TO. Obstet Gynecol. 2002: Linn ES. Int J Fertil et al. Very Effective

Menstrual-related health benefits: Decreased dysmenorrhea Decreased menstrual blood loss and anemia May reduce PMS symptoms Decreased risk of: Ectopic pregnancies Endometrial and ovarian cancer Benign breast conditions PID Very Effective Health Benefits: Combined Hormonal Contraception Larsson G. Contraception Parsey KS. Contraception Freeman EW. Fertil Steril Davis A. Obstet Gynecol. 2005

Side Effects: Hormonal Contraception Very Effective Estrogen-Related Breast tenderness Nausea Vomiting Headaches Elevated blood pressure (rare) Progestin-Related Bloating Anxiety Irritability Depression Menstrual irregularities Reduced libido

Very Effective Contraindications: Combined Hormonal Contraception WHO Clotting disorders History of deep vein thrombosis or pulmonary embolism Migraine with aura or focal neurological deficit Uncontrolled hypertension

Quick Start: Improving Contraceptive Initiation Start contraceptive method (OCs, implant, patch, ring, injection) in presence of clinician or on day of visit Menstrual cycle timing not a factor Use back-up method for 1 st 7 days Very Effective Lara-Torre E. Contraception Leeman L. Obstet Gynecol Clin N Am Westoff C. Contraception

Missed or Late Hormonal Contraception Combined Oral Contraceptive Pills Take missed pill ASAP Take next pill at regular time Use back-up method for 1 week if missed1-2 pills at the start of pack or 3 or more pills in the first 3 weeks of pack Progestin Only Pills Take missed pill ASAP Take next pill at regular time Use back-up method for 2 days if pill is taken >3 hours past regular time Very Effective Transdermal Patch Use back-up method for 1 week if patch has been on >9 days, off > 7 days or falls off and is not reaffixed within 24 hours Vaginal Ring Use back-up method for 1 week if ring has been in >5 weeks, out >7 days or falls out and is not reinserted within 3 hours

Case Study: Mikayla Age 19 Used DMPA for 2 years Physician told her to stop injections Is not using contraception now What would you recommend?

Case Study: Mikayla (continued) Key Points About DMPA: No evidence it causes fracture increase Bone mineral density returns to baseline after cessation of DMPA Bone health largely dependent on nutrition and exercise ACOG and WHO support long term use ACOG practice bulletin. Obstet Gynecol Cromer BA. Am J Obstet Gynecol DiVasta AD. Adolesc Med Kaunitz AM. Contraception Leeman L. Obstet Gynecol Clin N Am WHO. 2006

Depot Medroxyprogesterone Acetate (DMPA) Brand name: Depo-Provera ® Intramuscular or subcu- taneous injection every 3 months Trussel J. Contraceptive Technology Cromer BA. Am J Obstet Gynecol Trussel J. Contraception ; Westhoff C. Contraception et al. Injectable Very Effective

Protection from Pregnancy Immediately: Copper T IUD After 7 Days: LNG 52 IUS, LNG 13.5 IUS* Implant Pills Patch Ring Injectable *Backup contraception is not needed when either LNG IUS is inserted as directed

Typical Effectiveness of Contraception Adapted from: WHO. Family Planning: A Global Handbook Long acting reversible contraceptives (LARCs) Tier 1 Tier 2 Tier 4 Tier 3

Moderately Effective Contraceptives Male Condom, Withdrawal Female Condom, Sponge, Cervical Cap Diaphragm, Spermicide Fertility Awareness

Satisfaction with Contraceptive Methods % Satisfied Vaginal Ring IUD Injection OC Patch Condoms Other Revisiting Your Regular Women’s Health Care Visit

Case Study: Heather Age: 26 Abortion 2 years ago Relying on partner’s use of condoms What would you recommend?

Emergency Contraception LNG Pills (Brand) Plan B ® One Step: One 1.5mg LNG pill LNG Pills (Generic) Next Choice One Dose™ : One 1.5mg LNG pill My Way™: One 1.5mg LNG pill LNG tablets: two 0.75mg LNG pills Ulipristal acetate ella ® : One 30 mg ulipristal acetate pill Copper T IUD Highly effective method of EC Can be used as an ongoing contraception for 12 years Trussell 2011; Piaggio G. Lancet Task Force on Postovulatory Methods. Lancet Grimes DA. Ann Intern Med Croxatto HB. Contraceptin Raine T. Obstet Gynecol Gold MA. J Pediatr Adolesc Gynecol Grimes DA. Ann Intern Med

Dedicated Emergency Contraception Pills Available Glasier, et al. 2011; Moreau, Trussell 2011.

Case Study: Margarite Age: 29 In a lesbian relationship Has had unprotected sex with men What would you recommend?

CDC MEDICAL ELIGIBILITY CRITERIA FOR WOMEN WITH CERTAIN CHARACTERISTICS AND MEDICAL CONDITIONS PART II

Learning Objectives List the 4 levels in the numeric scheme described in the US Medical Eligibility Criteria for Contraceptive Use Explain the application of the numeric scheme to prescriptive practices for women with comorbid conditions Describe the risks and benefits of the different contraceptive methods against the risks of pregnancy in women with health-related concerns

US Medical Eligibility Criteria for Contraceptive Use CDC published criteria in June ‘10 Based on the 4 th edition of the World Health Organization guidelines from ‘09 Adapted for US women by panel of experts and CDC Recommendations for the use of specific contraceptives by women who have particular characteristics/medical conditions

WHO  CDC US MEC Existing WHO guidance Breastfeeding and hormonal methods Valvular heart disease and IUDs Postpartum IUD insertion Ovarian cancer and IUDs Fibroids and IUDs DVT/PE and hormonal methods and IUDs

WHO  CDC US MEC New medical conditions Rheumatoid arthritis Endometrial hyperplasia Inflammatory bowel disease Bariatric surgery Solid organ transplantation Peripartum cardiomyopathy

US Medical Eligibility Criteria: Organization Criteria are organized according to: – Contraceptive method – Patient characteristics (age, smoking status, etc.) – Preexisting conditions (hypertension, epilepsy, etc.) Criteria use a numeric scheme to provide the recommendations for contraceptives being used for contraceptive purposes only, not for treatment of medical conditions

1 No restriction for the use of the contraceptive method for a woman with that medical condition 2 Advantages of using the method generally outweigh the theoretical or proven risks 3 Theoretical or proven risks of the method usually outweigh the advantages – or that there are no other methods that are available or acceptable to the women with that medical condition 4 Unacceptable health risk if the contraceptive method is used by a woman with that medical condition US Medical Eligibility Criteria: Categories

Conditions Associated w/ ↑ Risk for Adverse Heath Events as a Result of Unintended Pregnancy Breast cancer Malignant liver tumors (hepatoma) and hepatocellular carcinoma of the liver Complicated valvular heart diseasePeripartum cardiomyopathy Diabetes: insulin dependent; with nephropathy/retinopathy/neuropathy or other vascular disease; or of >20 years’ duration Schistosomiasis with fibrosis of the liver Endometrial or ovarian cancerSevere (decompensated) cirrhosis EpilepsySickle cell disease Hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg) Solid organ transplantation within the past 2 years History of bariatric surgery within past 2 yearsStroke HIV/AIDSSystemic lupus erythematosus Ischemic heart diseaseThrombogenic mutations Malignant gestational trophoblastic diseaseTuberculosis US Medical Eligibility Criteria: ↑ Risk for Adverse Health Events Should consider long- acting, highly-effective contraception for these patients

Pregnancy-Related Mortality Increase in pregnancy-related mortality, ▪ De-identified death certificates of women who died during or within 1 year of pregnancy ▪ Matched birth or fetal death certificates Pregnancy-related mortality ▪ 14.5 per 100,000 live births ▫African American, 3-4 times greater risk ▫Decreased deaths due to hemorrhage and hypertensive disorders ▫Increased deaths due to medical conditions, especially CVD Berg, CJ et al. Obstet Gynecol. 2010;116:

Case Presentation 1 Which hormonal methods are safe for her to use? A. Combined hormonal methods only B. Progestin-only methods only C. Any hormonal method 30-year-old PPD #2 Ready to be discharged from hospital & desires contraception Plans to breastfeed

Breastfeeding

Case Presentation 1 Which hormonal methods are safe for her to use? A. Combined hormonal methods only B. Progestin-only methods only C. Any hormonal method 30-year-old PPD #2 Ready to be discharged from hospital & desires contraception Plans to breastfeed

Case Presentation 2 Is this method safe for her? A. Yes B. No 25-year-old Has Crohn’s disease Desires long- term reversible contraception Thinking about levonorgestrel- releasing IUD

Inflammatory Bowel Disease

Case Presentation 2 Is this method safe for her? A. Yes (Category 1) B. No 25-year-old Has Crohn’s disease Desires long- term reversible contraception Thinking about levonorgestrel- releasing IUD

Case Presentation 3 What do you need to know before deciding whether to recommend this method? A. How much weight has she lost? B. What type of surgery did she have? C. What pill formulation did she use previously? 30-year-old History of bariatric surgery 6 months ago Was using COCs before surgery & wants to restart

Bariatric surgery Most effective weight loss treatment for morbid obesity From 1998 to 2005, incidence increased 800% Women account for 83% of procedures among reproductive age (ages 18-45)

Types of Bariatric surgery Restrictive procedures: ▪ Decrease storage capacity of stomach ▪ Ex: vertical banded gastroplasty, laparoscopic adjustable gastric band, laparoscopic sleeve gastrectomy Malabsorptive procedures: ▪ Decrease absorption of nutrients and calories by shortening functional length of small intestine ▪ Ex: Roux-en-Y gastric bypass (most common in US), biliopancreatic diversion

Bariatric Surgery Consensus: Pregnancy should be avoided for months after surgery Paulen, ME et al. Contraception 82 (2010)

History of Bariatric Surgery

Case Presentation 3 What do you need to know before deciding whether to recommend this method? A. How much weight has she lost? B. What type of surgery did she have? C. What pill formulation did she use previously? 30-year-old History of bariatric surgery 6 months ago Was using COCs before surgery & wants to restart

Next Steps Work with partners: ▪ dissemination ▪ implementation Keeping guidance up to date

Updated Guidance from WHO September 2010

What increased risk is posed by use of Combined Hormonal Contraceptives? No data specifically delineates risk of CHC use during the postpartum Baseline risk of VTE in non-pregnant, non- postpartum women: ▪ /10,000 WY CHC use increases risk: ▪ 3-7 fold Risk most pronounced in the first year of use

Previous WHO MEC recommendation CHCs in postpartum women < 21 days postpartum3 ≥ 21 days postpartum1

CHCs for women during the postpartum period ConditionRecommendationClarification Postpartum a. < 21 days Without other risk factors for VTE 3 With other risk factors for VTE 3/4The category should be assessed according to the number, severity, and combination of VTE risk factors present. b. > 21 days to 42 days Without other risk factors for VTE 2 With other risk factors for VTE 2/3The category should be assessed according to the number, severity, and combination of VTE risk factors present. c. > 42 days1

US MEC-Postpartum period New evidence Updated recommendations from WHO ▪ CDC held consultation in Jan 2011 ▪ Substantial increased risk in early weeks postpartum with no benefit ▪ Multiple risk factors Access issues Safety of other contraceptive methods Will be published as MMWR

Contraception: It’s More Than a Prescription

The Importance of Collecting a Sexual History Medical history Circumstances Lifestyle issues that affect adherence Preconceptions about contraceptive methods

What Does Patient-Centered Care Look Like?

Clinician Limitations

Patient Follow-up Schedule a recheck visit Ask follow-up questions: Are you satisfied with your contraceptive method? Is there anything you would change? Are you having bleeding problems or other side effects? ARHP. Clinical Proceedings

Recommendations for Providers Frost JJ. In Brief Provide ongoing support for contraceptive use Improve women’s knowledge of contraceptive risk and benefits Anticipate and manage side effects Recognize fluidity in reproductive goals Offer the widest range of contraceptive options Address logistical and cost barriers Enhance professional education and offer mutual support

Next Steps Work with partners: ▪ dissemination ▪ implementation Keeping guidance up to date Research gaps US adaptation of WHO Selected Practice Recommendations for Contraceptive Use

Resources US MEC published in CDC’s Morbidity and Mortality Weekly Report (MMWR): ▪ m?s_cid=rr5904a1_w m?s_cid=rr5904a1_w CDC evidence-based family planning guidance documents: ▪ ncy/USMEC.htm ncy/USMEC.htm WHO evidence-based family planning guidance documents: ▪ planning/en/index.html planning/en/index.html

Additional Resources Association of Reproductive Health Professionals (ARHP) ▪ National Association of Nurse Practitioners in Women’s Health (NPWH) ▪