Contraception and Sterilization UNC School of Medicine Obstetrics and Gynecology Clerkship Case Based Seminar Series 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 Contraception is important because unintended pregnancy in the U.S. is common • 6.3 million pregnancies Unintended Intended 22% 51% 49% Birth 22% 20% Abortion 20% 7% Fetal Loss 7% 3 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 Effective Prevents pregnancy ~81-90% of the time Prevents pregnancy up to 80% of the time Male/Female Condom Sponge Diaphragm Fertility awareness Cervical cap Spermicide 4 Distribution of contraception use by women in the US % of US women 15-44 years 25 22.8 20 17.3 15 10 10 5 2 3.2 3.4 0.8 2.2 0 Mosher, et al. 2010. 5 Unintended Pregnancy and Contraceptive Use Consistent use, method failed, 5% Inconsistent or incorrect use, 43% Nonuse, 52% 3.1 million unintended pregnancies, by women's contraceptive use during month of conception Frost JJ, Darroch JE, Remez L. In Brief. 2008. 6 Direct counseling to focus on effectiveness http://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf 7 Resources for contraceptive counseling and prescribing 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 8 USMEC Definitions Category Definition 1 A condition for which there is no restriction for the use of the contraceptive method 2 A condition for which there is no restriction for the use of the contraceptive method 3 A condition for which the theoretical or proven risks usually outweigh the advantages of using the method 4 A condition for which the theoretical or proven risks usually outweigh the advantages of using the method http://www.cdc.gov/mmwr/pdf/rr/rr59e0528.pdf 9 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 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 Current Contraceptive Options Most effective Prevents pregnancy >99% of the time Male/Female Sterilization IUD/IUS Implants Moderately effective Effective Prevents pregnancy ~91-99% of the time Prevents pregnancy ~81-90% of the time Prevents pregnancy up to 80% of the time Pills Injectables Patch Ring Male/Female Condom Sponge Diaphragm Fertility awareness Cervical cap Spermicide Very effective 12 Male sterilization (permanent contraception) Most effective Prevents pregnancy >99% of the time Male Sterilization •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 13 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 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 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 Levonorgestrel Intrauterine System (LNG IUS) Most effective Prevents pregnancy >99% of the time IUD/IUS 17 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 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 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 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 Copper-T IUD Most effective Prevents pregnancy >99% of the time ParaGard® Copper T-380a Labeled for 10 years of continuous use Evidence supports use up to 12 years continuous use Cu-T380a IUD 22 Copper-T IUD Mechanism of action Copper induces a spermicidal environment in the uterus 23 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 Copper-T IUD Contraindications VERY FEW Wilson’s Disease Active cervical or pelvic infection 25 Intrauterine contraception (IUC) Busting myths and misconceptions 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 26 Intrauterine contraception (IUC) Busting myths and misconceptions 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 27 Subdermal Implant Most effective Prevents pregnancy >99% of the time Brand name: Implanon® Releases 60 mcg etonogestrel per day Effective for 3 years Implants Implanon insert: Diaz S., Contraception, 2002: Trussel J, Contraceptive Technology, 2007 Croxatto HB, Contraception, 1998; Diaz S, 28 Contraception, 2002; Funk S, Contraception, 2005. Implanon Prescribing Information. et al. Subdermal Implant Mechanism of action Ovulation suppression Implanon insert: Diaz S., Contraception, 2002: Trussel J, Contraceptive Technology, 2007 Croxatto HB, Contraception, 1998; Diaz S, 29 Contraception, 2002; Funk S, Contraception, 2005. Implanon Prescribing Information. et al. 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 Subdermal Implant Contraindications Some antiepileptic drugs Inability to manage irregular and unpredictable menses 31 Depot Medroxyprogesterone Acetate (DMPA) Very effective Brand name: Depo-Provera® Intramuscular or subcutaneous injection every 13 weeks Prevents pregnancy ~91-99% of the time Injectables Trussel J. Contraceptive Technology. 2007. Cromer BA. Am J Obstet Gynecol. 2005. Trussel J. Contraception. 2004.; Westhoff C. Contraception. 2003. et al. 32 Injectable Mechanism of action Very effective Prevents pregnancy ~91-99% of the time Thickens cervical mucus so it becomes impervious to sperm Ovulation suppression Makes the endometrium inhospitable to ovum Injectables 33 Injectable Benefits and risks Very effective Prevents pregnancy ~91-99% of the time Injectables 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. 34 DMPA Contraindications Very effective Prevents pregnancy ~91-99% of the time Injectables 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 35 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 Vaginal Ring Very effective Brand name: NuvaRing® Flexible, unfitted ring placed in vagina Prevents pregnancy ~91-99% of the time 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 Ring 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. 37 Vaginal Ring Mechanism of action Very effective Prevents pregnancy ~91-99% of the time 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 Ring 38 Vaginal Ring Benefits and risks Very effective Failure rate 1/100 in first year Lasts for three weeks Prevents pregnancy ~91-99% of the time Steady state of medications Decreased intermenstrual bleeding compared to pills Ring 39 Vaginal Ring Contraindications Very effective Contraindicated in women who are over 35 and smoke, who have hypertension, who have a history of VTE Prevents pregnancy ~91-99% of the time Pharmacokinetic profile theoretically similar to OCP, although minimal evidence to support Theoretically there is a bypass of first pass metabolism. Ring 40 Combined Oral Contraceptives Very effective Contain estrogen & progestin 20 – 35 mcg of ethinyl estradiol Prevents pregnancy ~91-99% of the time and One of eight synthetic progestins Formulations 28-day Pills 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. 41 Combined Oral Contraceptives Mechanism of action Very effective Prevents pregnancy ~91-99% of the time 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 Pills 42 Combined Oral Contraceptives Counseling Very effective Prevents pregnancy ~91-99% of the time Pills 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 43 Combined Oral Contraceptives Benefits and risks Very effective Easy to dispense Easy to store Prevents pregnancy ~91-99% of the time Pills 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. 44 Combined Oral Contraceptives Contraindications Very effective Prevents pregnancy ~91-99% of the time Absolute contraindications • Older than 35 and smoking (increased risk of MI 11x) • Prior history of VTE Relative contraindications Relative Contraindications Pills Migraines with aura Hypertension Use the MEC to guide your decision making 45 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. 46 Obstet Gynecol. 2005. Kwiecien M. Contraception. 2003. Sulak PJ. Am J Obstet Gynecol 2002. Extended contraception Women generally like having fewer menses Never Every 6 Months Every 3 Months Every Other Month Every Month 40% 16% 13% ARHP Greenberg Quinlan Rosner Survey 2005. 47 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 Generic Contraceptives Pharmacies may provide different substitutions each month May/may not ↓ costs for those paying out of pocket 49 Transdermal Patch Very effective Prevents pregnancy ~91-99% of the time Brand name: OrthoEvra® Beige-colored patch applied once per week Patch 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. 50 Transdermal Patch Mechanism of action Very effective Prevents pregnancy ~91-99% of the time 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 Patch 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. 51 Transdermal Patch Benefits and risks Very effective Prevents pregnancy ~91-99% of the time Patch 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. 52 Transdermal Patch Contraindications Very effective Prevents pregnancy ~91-99% of the time 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) Patch 53 Progestin-Only Oral Contraceptives Very effective Prevents pregnancy ~91-99% of the time Called the “mini-pill” Two formulations: norethindrone & norgestrel Failure rate: <1 – 3 out of 100 women in their first year of use Patch Apgar BS. AFP. 2000; WHO MEC. 2004. Contraception Report. 1999. Apgar BS. AFP. 2000. et al. 54 Progestin-Only Oral Contraceptives Mechanism of action Very effective Prevents pregnancy ~91-99% of the time Thickens cervical mucus so impermeable to sperm Decreased frequency of ovulation, but doesn’t create fully anovulatory state POP Apgar BS. AFP. 2000; WHO MEC. 2004. Contraception Report. 1999. Apgar BS. AFP. 2000. et al. 55 Progestin-Only Oral Contraceptives Benefits and risks Very effective Prevents pregnancy ~91-99% of the time POP 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 Progestin-Only Oral Contraceptives Contraindications Very effective Prevents pregnancy ~91-99% of the time •Very few •Severe thromboembolic disorder •Active liver disease POP 57 Male Condom Composition Latex Polyurethane Silicone rubber Failure rates: 3-14% in first year of use 1-5% slippage 1-8% breakage Emergency contraception (EC) Hatzell T. Sex Transm Dis. 2001. Trussel J. Fam Plann Perspect 1994. Trussel J. Contraceptive Technology. 2007. 58 Male Condom Must be used correctly and consistently Should always be used for the prevention of STI’s Hatzell T. Sex Transm Dis. 2001. Trussel J. Fam Plann Perspect 1994. Trussel J. Contraceptive Technology. 2007. 59 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 Sponge •Failure rate 9-40% •Higher failure in parous women •Available over the counter Engender Health. 2005. Trussel J. 2007. 61 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 Fertility Awareness Failure rate 9-24% in first year Multiple methods: Rhythm method Standard days method Brand name: CycleBeadsTM LAM Billings ovulation method Symptothermal method Arevalo M. Contraception. 2002. CycleBeads Product Information. 63 Spermicide 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. 64 Emergency contraception “The condom broke last night” 65 EC Available in the United States Combined Pills Progestin-only Pills Copper-T IUD Dedicated Products: ® Plan B ® Ella Trussell J, Raymond EG. 2007. 66 Emergency Contraceptive Dedicated products ® 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), 2nd 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. 67 Emergency Contraceptive Pills Using Ordinary OCP’s Ordinary oral contraceptive pills containing both estrogen and progestin Pill Plan-B Ovral Lo/Ovral Seasonal Triphasil Alesse Pills per dose 1 white pill 2 white pills 4 white pills 4 pink pills 4 yellow pills 5 pink pills Trussell J, Raymond EG. 2007. Ethinyl Estradiol per dose (mcg) Levonorgestrel per dose (mg) 0 100 120 120 120 100 0.75 0.50 0.60 0.60 0.50 0.50 68 Emergency Contraception: IUD Insertion 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. 69 Effectiveness of EC Methods If 1000 women have unprotected sex once during Week 2 or 3 of their cycle # of % Pregnancies Reduction No treatment Combined ECPs Progestin-only ECPs IUD Insertion Trussell J, Raymond EG. 2007. 80 20 10 1 75% 88% 99% 70 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 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 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 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 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 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 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®, CopperIUD and is most effective if taken soon after intercourse 77 References and Resources APGO Medical Student Educational Objectives, 9th 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 (p223239). 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