1. Contraception and Sterilization UNC School of Medicine Obstetrics and Gynecology Clerkship Case Based Seminar Series

2. Objectives for Contraception and Sterilization  Describe the mechanism of action and effectiveness of contraceptive methods  Counsel the patient regarding the benefits, risks, and use for each contraceptive method  Describe barriers to effective contraceptive use and to the reduction of unintended pregnancy  Describe the methods of male and female surgical sterilization  List the risks and benefits of female surgical sterilization procedures 2

3. Contraception is important because unintended pregnancy in the U.S. is common Birth 22% Abortion 20% Fetal Loss 7% Unintended49% 6.3 million pregnancies Intended51% 22% 20% 7% 3

4. Current contraceptive Methods available in the US Most effective Prevents pregnancy >99% of the time Male/Female Sterilization IUD/IUS Implants Very effective Prevents pregnancy ~91-99% of the time Pills Injectables Patch Ring Moderately effective Prevents pregnancy ~81-90% of the time Male/Female Condom Sponge Diaphragm Effective Prevents pregnancy up to 80% of the time Fertility awareness Cervical cap Spermicide 4

5. Distribution of contraception use by women in the US Mosher, et al. 2010. % of US women 15-44 years 5

6. Unintended Pregnancy and Contraceptive Use 3.1 million unintended pregnancies, by women's contraceptive use during month of conception Consistent use, method failed, 5% Inconsistent or incorrect use, 43% Nonuse, 52% Frost JJ, Darroch JE, Remez L. In Brief. 2008. 6

7. Direct counseling to focus on effectiveness http://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf 7

8.  Evidence based guidance for the use of contraception with health conditions  U.S. Medical Eligibility Criteria  http://www.cdc.gov/mmwr/pdf/rr/rr59e0528.pdf http://www.cdc.gov/mmwr/pdf/rr/rr59e0528.pdf Resources for contraceptive counseling and prescribing 8

9. USMEC Definitions CategoryDefinition 1 A condition for which there is no restriction for the use of the contraceptive method 2 3 A condition for which the theoretical or proven risks usually outweigh the advantages of using the method 4 http://www.cdc.gov/mmwr/pdf/rr/rr59e0528.pdf 9

10. Using USMEC; (e.g. for hypertension)  Pages 12-13 for HTN with combined oral contraceptives  Risks generally outweigh the benefits and alternative methods exist  Increased risk of stroke among women with HTN and on COC’s compared to women not on COC’s  P 35-36 for HTN and progestin contraceptives  Benefits generally outweigh the risks  P.53 for HTN and IUC  Benefits outweigh the risks 10

11. Cost Basically all are remarkably similar Implants and intrauterine contraceptive most cost effective Hormonal contraception – about $30- $40/month ($360-$480 per year) Mirena® - $750/7 years ($108/year) Cu-T380a IIUD - @$600/12 yrs ($50/year) 11

12. Current Contraceptive Options Most effective Prevents pregnancy >99% of the time Male/Female Sterilization IUD/IUS Implants Very effective Prevents pregnancy ~91-99% of the time Pills Injectables Patch Ring Moderately effective Prevents pregnancy ~81-90% of the time Male/Female Condom Sponge Diaphragm Effective Prevents pregnancy up to 80% of the time Fertility awareness Cervical cap Spermicide 12

13. Male sterilization (permanent contraception) Most effective Prevents pregnancy >99% of the time Male Sterilization 13 Vasectomy Failure rate 5/1000 in first year of use 0.1 – 0.15 in first year Absence of sperm should be documented Cost about $200

14. Male sterilization (permanent contraception) Most effective Prevents pregnancy >99% of the time Male Sterilization Surgeons who do more than 10/year have lower complication rates Successfully reversed only 50% of time Rare side effects – Hematomas and infection No increased risk of prostate or testis cancer No adverse health consequences 14

15. Female sterilization Methods Most effective Prevents pregnancy >99% of the time Female Sterilization Laparoscopy – Coagulation – Filschie clips Minilaparotomy Postpartum Used by 27% of couples in US 15

16. Female sterilization Benefits and Risks Most effective Prevents pregnancy >99% of the time Female Sterilization Mortality lower than childbearing (1.5/100,000 compared to 8/100,000) Failure rate 0.2 -0.4 per 100 women in first year Cost about $2000 16

17. Levonorgestrel Intrauterine System (LNG IUS) Most effective Prevents pregnancy >99% of the time IUD/IUS 17

18. Levonorgestrel Intrauterine System (LNG IUS)  Brand name: Mirena ®  20 mcg levonorgestrel/day  Approved for 5 years use, evidence supports use up to 7 years  Decreased menstrual bleeding in 80% users by 1 year  Amenorrhea in ~20% of users by 1 year 18

19. LNG IUS Mechanism of action  Progestin results in decreased tubal motility)  Thickened cervical mucus  Endometrium becomes decidualized with atrophy of the glands  Cycles are ovulatory in 50-75% of women 19

20. LNG IUS Benefits and Risks  Decreases menstrual blood loss by 40-50%  Decreases amenorrhea  Can treat and prevent endometrial hyperplasia  One of the most effective methods  “Forgettable”  Rapidly reversed upon removal  5% risk of expulsion in first year  1/1000 risk of perforation at insertion  <1/1000 risk of infection in first 20 days after insertion 20

21. Levonorgestrel Intrauterine System Contraindications  Contraindications – all are relative, and involve counseling of risks vs. benefits  Prior ectopic (progestin results in decreased tubal motility)  Active cervical or reproductive organ infection  Undiagnosed abnormal uterine bleeding 21

22. Copper-T IUD  ParaGard®  Copper T-380a  Labeled for 10 years of continuous use  Evidence supports use up to 12 years continuous use Most effective Prevents pregnancy >99% of the time Cu-T380a IUD 22

23. Copper-T IUD Mechanism of action  Copper induces a spermicidal environment in the uterus 23

24. Copper-T IUD Benefits and risks  “Forgettable” contraception  Lasts for 12 years  Highly effective  May cause slightly heavier menses in the first three months of use  Expulsion up to 5% in the first year  1/1000 risk of perforation at time of insertion 24

25.  Contraindications  VERY FEW  Wilson’s Disease  Active cervical or pelvic infection Copper-T IUD 25

26.  Can be used in nulliparous women  Can be used in adolescents  Can be used for 7-12 continuous years (method dependent)  Can be placed without waiting for a GC/Chl screen result Intrauterine contraception (IUC) Busting myths and misconceptions 26

27.  Can be used in a woman with a history of pelvic inflammatory disease  No antibiotics required at placement  An STI or PID with IUC in place doesn’t require IUC removal for treatment Intrauterine contraception (IUC) Busting myths and misconceptions 27

28. Subdermal Implant  Brand name: Implanon®  Releases 60 mcg etonogestrel per day  Effective for 3 years Implanon insert: Diaz S., Contraception, 2002: Trussel J, Contraceptive Technology, 2007 Croxatto HB, Contraception, 1998; Diaz S, Contraception, 2002; Funk S, Contraception, 2005. Implanon Prescribing Information. et al. Most effective Prevents pregnancy >99% of the time Implants 28

29. Subdermal Implant Mechanism of action  Ovulation suppression Implanon insert: Diaz S., Contraception, 2002: Trussel J, Contraceptive Technology, 2007 Croxatto HB, Contraception, 1998; Diaz S, Contraception, 2002; Funk S, Contraception, 2005. Implanon Prescribing Information. et al. 29

30. Subdermal Implant Benefits and risks  “Forgettable”  Rapidly reversible upon removal  Decreased menstrual bleeding  Good for persons who don’t want something in their uterus  Unpredictable vaginal bleeding for duration of use  Menstrual bleeding is highly variable 30

31.  Some antiepileptic drugs  Inability to manage irregular and unpredictable menses Subdermal Implant Contraindications 31

32.  Brand name: Depo-Provera ®  Intramuscular or subcutaneous injection every 13 weeks Trussel J. Contraceptive Technology. 2007. Cromer BA. Am J Obstet Gynecol. 2005. Trussel J. Contraception. 2004.; Westhoff C. Contraception. 2003. et al. Depot Medroxyprogesterone Acetate (DMPA) Very effective Prevents pregnancy ~91-99% of the time Injectables 32

33.  Thickens cervical mucus so it becomes impervious to sperm  Ovulation suppression  Makes the endometrium inhospitable to ovum Injectable Mechanism of action Very effective Prevents pregnancy ~91-99% of the time Injectables 33

34.  Redose every three months  Only 6 failures per 100 women in the first year of use  Irregular bleeding for first 3-6 months  Amenorrhea after 6 months of use  Not associated with long term bone loss  Encourage women to eat healthy and be active to help avoid weight gain.  Consider future fertility plans – can take up to 18 months for regular monthly menses to resume. Injectable Benefits and risks Very effective Prevents pregnancy ~91-99% of the time Injectables 34

35.  Minimal  Inability to manage irregular and unpredictable menses in first 6 months of use  Inability to tolerate amenorrhea  Desire to become pregnant within two years  Severe coagulation disorders  History of sex hormone induced liver adenoma DMPA Contraindications Very effective Prevents pregnancy ~91-99% of the time Injectables 35

36. Special consideration DMPA and bone loss  The medical literature demonstrates that bone mineral density (BMD) loss associated with DMPA is substantially reversed after discontinuation in premenopausal women after DMPA treatment for up to 5 years  ACOG and WHO support long-term use of DMPA for contraception for women 18 to 45 years old  ACOG and WHO state the advantages of DMPA likely outweigh the theoretical and safety concerns 36

37. Vaginal Ring  Brand name: NuvaRing ®  Flexible, unfitted ring placed in vagina  Can be difficult for women to start using this method, but once they start they are pleased with it  Leave in for 3 weeks  Can take out for longer than 3 hrs in one 24 hour period without decrease in effectiveness NuvaRing Prescribing Information. Organon. 2001: Timmer CJ. Clin Pharmacokinet. 2000. Herndon EJ. Am Fam Physician. 2004: Dieben TO. Obstet Gynecol. 2002: Linn ES. Int J Fertil. 2003. et al. Very effective Prevents pregnancy ~91-99% of the time Ring 37

38. Vaginal Ring Mechanism of action  Anovulation by suppressing LH and FSH  Thickening of the cervical mucus so impervious to sperm  Alteration of endometrial lining so no longer receptive to ovum Very effective Prevents pregnancy ~91-99% of the time Ring 38

39. Vaginal Ring Benefits and risks  Failure rate 1/100 in first year  Lasts for three weeks  Steady state of medications  Decreased intermenstrual bleeding compared to pills Very effective Prevents pregnancy ~91-99% of the time Ring 39

40.  Contraindicated in women who are over 35 and smoke, who have hypertension, who have a history of VTE  Pharmacokinetic profile theoretically similar to OCP, although minimal evidence to support  Theoretically there is a bypass of first pass metabolism. Vaginal Ring Contraindications Very effective Prevents pregnancy ~91-99% of the time Ring 40

41. Combined Oral Contraceptives  Contain estrogen & progestin  20 – 35 mcg of ethinyl estradiol and  One of eight synthetic progestins  Formulations  28-day  84 day  Extended (longer than three months) Trussel J. Contraceptive Technology. 2007:Rosenberg MJ. Reprod Med. 1995: Potter L. Fam Plann Perspect. 1996; Mosher WD. AdvanceData. 2004. Hardman JG. McGraw-Hill. 1996.: Goldzieher JW. Fertil Steril. 1971.: Moghissi KS. Fertil Steril. 1971. Very effective Prevents pregnancy ~91-99% of the time Pills 41

42. Combined Oral Contraceptives Mechanism of action Very effective Prevents pregnancy ~91-99% of the time Pills 42  Anovulation by suppressing LH and FSH  Thickening of the cervical mucus so impervious to sperm  Alteration of endometrial lining so no longer receptive to ovum

43. Combined Oral Contraceptives Counseling Very effective Prevents pregnancy ~91-99% of the time Pills 43  If using monthly dosing the most important pill to not forget is the first pill of anew pack  Not teratogenic  If menses are missed don’t stop taking the pill:  Take a urine pregnancy test  Continue taking the pill as directed  If test positive then call MD

44. Combined Oral Contraceptives Benefits and risks  Easy to dispense  Easy to store  Effectiveness highly dependent upon adherence by the user  Slight increased risk of venous thromboembolic events – but this risk is much lower than the risk of a VTE in pregnancy Trussel J. Contraceptive Technology. 2007:Rosenberg MJ. Reprod Med. 1995: Potter L. Fam Plann Perspect. 1996; Mosher WD. AdvanceData. 2004. Hardman JG. McGraw-Hill. 1996.: Goldzieher JW. Fertil Steril. 1971.: Moghissi KS. Fertil Steril. 1971. Very effective Prevents pregnancy ~91-99% of the time Pills 44

45. Absolute contraindications Older than 35 and smoking (increased risk of MI 11x) Prior history of VTE Relative contraindications  Relative Contraindications  Migraines with aura  Hypertension Use the MEC to guide your decision making Combined Oral Contraceptives Contraindications Very effective Prevents pregnancy ~91-99% of the time Pills 45

46. Extended Hormonal Contraception  Delays or eliminates menstruation  Menstrual and nonmenstrual benefits  Extended methods:  Continuous use of COCs, transdermal patch & vaginal ring  Seasonale ®, Seasonique & Lybrel - dedicated extended OC regimen Anderson FD. Contraception. 2003. Kaunitz AM. Contraception. 2000. ARHP. 2003. NuvaRing Product Information. 2001. Stewart FH. Obstet Gynecol. 2005. Kwiecien M. Contraception. 2003. Sulak PJ. Am J Obstet Gynecol 2002. 46

47. Extended contraception Women generally like having fewer menses ARHP Greenberg Quinlan Rosner Survey 2005. Never Every 6 Months Every 3 Months Every Other Month Every Month 16% 13% 40% 47

48. Extended Contraception Candidates for Reduced Menstruation  Women with menstrual-related disorders or anemia  Adolescents  Perimenopausal women  Athletes  Women in the military  Developmentally delayed women  Any woman who chooses to bleed less frequently 48

49. Generic Contraceptives  Pharmacies may provide different substitutions each month  May/may not ↓ costs for those paying out of pocket 49

50.  Brand name: OrthoEvra ®  Beige-colored patch applied once per week Abrams LS. Fertil Steril. 2002: Ortho Evra Prescribing Information. Archer DF, et al. Fertil Steril. 2002.; Zacur HA, et al. Fertil Steril. 2002.; Zieman M, et al. Fertil Steril. 2002.; Archer DF, et al. Contraception. 2004.; Audet MC, et al. JAMA. 2001. Transdermal Patch Very effective Prevents pregnancy ~91-99% of the time Patch 50

51. Abrams LS. Fertil Steril. 2002: Ortho Evra Prescribing Information. Archer DF, et al. Fertil Steril. 2002.; Zacur HA, et al. Fertil Steril. 2002.; Zieman M, et al. Fertil Steril. 2002.; Archer DF, et al. Contraception. 2004.; Audet MC, et al. JAMA. 2001. Transdermal Patch Mechanism of action Very effective Prevents pregnancy ~91-99% of the time Patch 51  Anovulation by suppressing LH and FSH  Thickening of the cervical mucus so impervious to sperm  Alteration of endometrial lining so no longer receptive to ovum

52.  Only change once a week  May result in rash or irritation at side of administration  Associated with higher serum levels of estradiol however this has not corroborated with increased risk of VTE Abrams LS. Fertil Steril. 2002: Ortho Evra Prescribing Information. Archer DF, et al. Fertil Steril. 2002.; Zacur HA, et al. Fertil Steril. 2002.; Zieman M, et al. Fertil Steril. 2002.; Archer DF, et al. Contraception. 2004.; Audet MC, et al. JAMA. 2001. Transdermal Patch Benefits and risks Very effective Prevents pregnancy ~91-99% of the time Patch 52

53.  Increased risk of, or history of, stroke, VTE  Hypertension  Allergy to components of the medication  Avoid in women over 35 who smoke (like oral contraceptives) Transdermal Patch Contraindications Very effective Prevents pregnancy ~91-99% of the time Patch 53

54. Progestin-Only Oral Contraceptives  Called the “mini-pill”  Two formulations: norethindrone & norgestrel  Failure rate:  <1 – 3 out of 100 women in their first year of use Apgar BS. AFP. 2000; WHO MEC. 2004. Contraception Report. 1999. Apgar BS. AFP. 2000. et al. Very effective Prevents pregnancy ~91-99% of the time Patch 54

55. Progestin-Only Oral Contraceptives Mechanism of action  Thickens cervical mucus so impermeable to sperm  Decreased frequency of ovulation, but doesn’t create fully anovulatory state Apgar BS. AFP. 2000; WHO MEC. 2004. Contraception Report. 1999. Apgar BS. AFP. 2000. et al. 55 Very effective Prevents pregnancy ~91-99% of the time POP

56. Progestin-Only Oral Contraceptives Benefits and risks  No estrogen so can be used by women unable to take estrogen containing contraception  Less forgiving – i.e. if a woman is more than 4 hours late taking her pill she should use a back up method (condom) for 48 hours  Failure rate higher than with combined oral contraceptives Apgar BS. AFP. 2000; WHO MEC. 2004. Contraception Report. 1999. Apgar BS. AFP. 2000. et al. 56 Very effective Prevents pregnancy ~91-99% of the time POP

57. 57 Progestin-Only Oral Contraceptives Contraindications Very effective Prevents pregnancy ~91-99% of the time POP Very few Severe thromboembolic disorder Active liver disease

58. Male Condom Hatzell T. Sex Transm Dis. 2001. Trussel J. Fam Plann Perspect 1994. Trussel J. Contraceptive Technology. 2007.  Composition  Latex  Polyurethane  Silicone rubber  Failure rates:  3-14% in first year of use  1-5% slippage  1-8% breakage  Emergency contraception (EC) 58

59. Male Condom Hatzell T. Sex Transm Dis. 2001. Trussel J. Fam Plann Perspect 1994. Trussel J. Contraceptive Technology. 2007.  Must be used correctly and consistently  Should always be used for the prevention of STI’s 59

60. Female Condom  Brand name: Reality ®  Failure 5-21% in first year of use  Polyurethane  High cost and poor acceptability are biggest barriers Hatzell T. Sex Transm Dis. 2001. Trussel J. Fam Plann Perspect 1994. Trussel J. Contraceptive Technology. 2007. 60

61. Sponge Engender Health. 2005. Trussel J. 2007. 61 Failure rate 9-40% Higher failure in parous women Available over the counter

62. Diaphragm  Not very popular  Failure rate 6-12%  Made of latex  Must be fitted by a physician  Used with a spermicide  Must be used consistently and correctly Fihn SD. JAMA. 1985. D’Oro LC. Genitourin Med. 1994. Trussel J. Contraceptive Technology. 2007. 62

63. Arevalo M. Contraception. 2002. CycleBeads Product Information.  Failure rate 9-24% in first year  Multiple methods:  Rhythm method  Standard days method  Brand name: CycleBeads TM  LAM  Billings ovulation method  Symptothermal method Fertility Awareness 63

64.  Failure rate 6-26% if used alone  Available as creams, gels, film, foam, and suppositories containing nonoxynol-9  Used alone or with a barrier method Roddy RE. N Engl J Med. 1998. Trussel J. Contraceptive Technology. 2007. Spermicide 64

65. Emergency contraception “The condom broke last night” 65

66. EC Available in the United States Copper-T IUD Combined Pills Dedicated Products: Plan B ® Ella ® Progestin-only Pills Trussell J, Raymond EG. 2007. 66

67.  0.75mg levonorgestrel (Plan B ® )  2 pills  Take 1st dose within 120 hours s/p intercourse (FDA-approved for only 96 hours s/p intercourse), 2 nd dose 12 hours later  Or take both pills at the same time (within 120 hours s/p intercourse) -> more side effects  Effectiveness decreases over time  30mg ulipristal acetate x 1 (Ella)  1 pill within 120h s/p intercourse  selective progesterone receptor modulator  Effectiveness maintained through five days  Both prevent ovulation and thin the endometrium Trussell J, Raymond EG. 2007. Faculty of Sexual and Repro Health New Product Review, 2009. Emergency Contraceptive Dedicated products 67

68. Emergency Contraceptive Pills Using Ordinary OCP’s  Ordinary oral contraceptive pills containing both estrogen and progestin Trussell J, Raymond EG. 2007. 68

69.  Copper-T IUD (ParaGard)  Insertion within 5 days after unprotected sex  Provides 10 additional years of highly effective contraception  Much more effective than ECPs Trussell J, Raymond EG. 2007. Emergency Contraception: IUD Insertion 69

70. If 1000 women have unprotected sex once during Week 2 or 3 of their cycle # of Pregnancies % Reduction No treatment80- Combined ECPs2075% Progestin-only ECPs1088% IUD Insertion199% Trussell J, Raymond EG. 2007. Effectiveness of EC Methods 70

71. CASE 1 A 19 year-old G0 comes into your office for contraceptive counseling. She has been using Depo-Medroxyprogesterone Acetate for 2 years. She thinks she should switch to a different method 1.What are the risks and benefits to DMPA? 2.How effective is DMPA? 3.Does she need to worry about bone loss? 71

72. CASE 2 A 25 year-old graduate student comes to see you for her annual exam and contraception refill. She has a busy year of exams and travel coming up and wants to have fewer menses but she heard it isn’t safe not to have a monthly bleed. 1.What is extended cycle contraception? 2.What are some of the benefits of extended cycle contraception? 3.How effective is extended cycle contraception? 72

73. CASE 3 A 28 year old G0 calls your office. The condom broke last night. Her last period was 8 days ago. She wants to use the “morning after pill”. 1.Emergency contraception comes in what different forms? 2.If she is unable to obtain EC today when is the latest she can obtain it and still have some protection against pregnancy? 73

74. CASE 4 A 40 year-old comes into your office for the birth control pill. She really wants to take it because she is certain she will have no difficulties remembering the pill and she wants the advantages of cycle control. However she travels by air frequently so she is concerned about the risk of venous thromboembolic events. 1.What additional health status information do you want to know before writing the prescription? 2.What are her risks of VTE? 3.What are the contraindications to the COC? 74

75. CASE 5 A 24 year-old G0 was treated for Chlamydia 9 months ago. Her last period was 2 weeks ago. She wants intrauterine contraception. 1.How will you counsel her regarding her history of Chlamydia? 2.How will you help her decide between 75

76. Bottom Line Concepts 1.The most effective contraceptive methods are those which require the least amount of effort from the user 2.Barriers to use include cost and availability 3.Counseling on proper use of all contraceptive methods is the key to success 76

77. Bottom Line Concepts 1.The IUD can be used by young women, nulliparous women and women who have had sexually transmitted infections 2.The IUD does not increase the risk of PID 3.Women older than 35 who smoke shouldn’t use combined oral contraceptives 4.DMPA is safe to use for many years 5.Extended cycle contraception is safe to use 6.Emergency contraception is in the form of PlanB®, Ella®, Copper- IUD and is most effective if taken soon after intercourse 77

78. References and Resources  APGO Medical Student Educational Objectives, 9 th edition, (2009), Educational Topic 70 (p70-71).  Beckman & Ling: Obstetrics and Gynecology, 6th edition, (2010), Charles RB Beckmann, Frank W Ling, Barabara M Barzansky, William NP Herbert, Douglas W Laube, Roger P Smith. Chapter 24, 25 (p223- 239).  Hacker & Moore: Hacker and Moore's Essentials of Obstetrics and Gynecology, 5th edition (2009), Neville F Hacker, Joseph C Gambone, Calvin J Hobel. Chapter 26 (p305-314). 78