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Intrauterine Contraception; A Method That Will Prevail! IUC/EMB/PCB Patty Cason, MS, FNP-BC UCLA School of Nursing.

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Presentation on theme: "Intrauterine Contraception; A Method That Will Prevail! IUC/EMB/PCB Patty Cason, MS, FNP-BC UCLA School of Nursing."— Presentation transcript:

1 Intrauterine Contraception; A Method That Will Prevail! IUC/EMB/PCB Patty Cason, MS, FNP-BC UCLA School of Nursing

2 Disclosure Expert Input Forum HPV Vaccine; Merck Speaker Merck; Gardasil, NuvaRing Trainer Merck; Nexplanon, Implanon Advisory board; ParaGard Teva Speaker & trainer; ParaGard Teva

3 3 Outline Attributes of LARC Methods Attributes of LARC Methods Characteristics of the IUC’s Characteristics of the IUC’s Reducing barriers to IUC use Reducing barriers to IUC use Management of side effects and complications Management of side effects and complications Step-by step insertion Step-by step insertion Tips for difficult insertions Tips for difficult insertions

4 4 “Politically Correct” Terminology Old name IUD: Intrauterine Device New names IUC: Intrauterine Contraception – Applied to Cu-T380 (ParaGard®) – Generic term for both types IUS: Intrauterine System – Applied to LNG-IUC (Mirena®)

5 5 The Case for LARC Methods More than 1/3 of all U.S. women will have had an induced abortion by age 45 20% of women selecting sterilization at age < 30 years later express regret Need for effective contraceptive methods that are “forgettable” Henshaw. Fam Plann Perspect 1998 Hillis et al. Obstet Gynecol 1999 Stanwood, NL. Obstet Gynecol 2002

6 6 U.S. Pregnancies: Unintended vs. Intended Henshaw: Fam Plann Perspect 1998;30: Unintended 49% Intended 51% Unintended births Elective Abortions 22.5% 26.5%

7 7 Contraceptive Use During Month of Unintended Pregnancy 5% consistent method use: method failure 43% used contraception 52% did not use contraception Guttmacher Institute In Brief Series

8 8 What are LARC Methods? Long Acting Reversible Contraception – IUCs: LNG-IUC,Cu-T380 – Implants: Etonogestrel Implant Long term continuous protection 24/7/365 protection… for 3-10 years Do not require episodic patient initiative for use Not daily Not weekly Not monthly Not even every 12 weeks

9 9 Why LARC Methods? They are “forgettable” Require just one motivational act The most effective reversible methods available Superior continuation rates Are among the safest contraceptive methods…very few US-MEC category 3 or 4 grades Highest patient satisfaction among methods No need to take time to refill prescriptions An alternative to surgical sterilization The most cost saving method of contraception

10 10 Contraceptive Efficacy Top Tier: Most Effective Female/male sterilization; IUC, Implant Middle Tier: Effective DMPA, Oral Contraceptive (OC), Patch, Ring Bottom Tier: Less Effective Barriers, Spermicides, Behavioral methods

11 11 Contraceptive Effectiveness and Continuation Rates Hatcher, RA et al; Contraceptive Technology 19th Edition,: 2007 Perfect Use Typical Use Continuation rate Implant (Implanon) % Male sterilization % IUC LNG-IUC (Mirena) Cu-T 380 (ParaGard) %78% Female sterilization % DMPA % OCs, Patch, Ring %

12 12 Cost savings per dollar expenditure by contraceptive method, Family PACT 2003 Foster, D. G. et al. Am J Public Health 2009;99:

13 13 Intrauterine Contraception in the U.S. Copper T-380 LNG-IUC Mechanism Spermicidal effect of copper Thickening of cervical mucus Duration Up to 10 years Up to 5 years Efficacy 0.8 failures/hwy 0.2 failures/hwy Benefit No hormones Less bleeding Non- contraceptive useNoneMenorrhagia Menstrual pain Cost (retail)$598/568$703

14 14 Client Choice of IUC Type Copper T IUC – Good method for women who don’t want hormonal contraception LNG IUC – Good method for women who request less menstrual flow or who experience dysmenorrhea

15 15 Copper T IUC: Mechanism of Action Primary mechanism is prevention of fertilization – Reduce motility and viability of sperm – Inhibit development of ova Inhibition of implantation is a secondary mechanism Alvarez Fertil Steril. 1988; Segal. Fertil Steril ACOG. Statement on Contraceptive Methods Alvarez F, Brache V, Fernandez E, et al. Fertil Steril. 1988;49:768 Segal SJ, Alvarez-Sanchez F, et al. Fertil Steril. 1985;44:214. ACOG. Statement on Contraceptive Methods, Washington DC:ACOG, July 1998 Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181: Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:

16 16 LNG-IUC Physical Characteristics levonorgestrel 20  g/day 32 mm Steroid reservoir

17 17 LNG-IUC: Contraceptive Mechanism Cervical mucus thickened Sperm motility and function inhibited Endometrium suppressed Ovulation inhibited (in some cycles) Jonsson et al. Contraception 1991;43:447 Videla-Rivero et al. Contraception 1987;36:217 Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181: Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:

18 18 Plasma Concentrations of Levonorgestrel Nilsson et al. Acta Endocrinol 1980;93:380 Diaz et al. Contraception 1987;35:551

19 19 Meta-Analysis: Mirena ® vs. Ablation for Heavy Menstrual Bleeding No difference between rates of treatment failures – 21.2% LNG-IUC vs. 17.9% endometrial ablation Both resulted in similar improvements in quality of life Less need for analgesia/anesthesia in LNG-IUC group Ablation requires additional effective contraception Kaunitz, et al. OG May;113(5): b.

20 20 Why Aren’t They Used More Frequently in the US? So….if IUCs are so good…

21 21 Contraception by Age (2008) Mosher WD. National Survey of Family Growth. Series 23, Number 29 August 2010

22 Increased Use of Intrauterine Contraception in California, 1997 to 2007 Modern intrauterine contraception is safe and highly effective, but is used by fewer than 4% of women in the United States. Previously recommended only for women with at least one child, now recommended for most women regardless of parity or age. 10 years of the California Women's Health Survey Thompson KM, et al. Womens Health Issues. 2011

23 Increased Use of Intrauterine Contraception in California, 1997 to 2007 Use of IUC in California almost doubled over the study period from 4.0% to 7.2% Women with the greatest increases were: – younger – born in the US – without a college degree – Asian IUC use among nulliparous women did not increase and IUC users were 71% less likely to be nulliparous Thompson KM, et al. Womens Health Issues. 2011

24 Increased Use of Intrauterine Contraception in California, 1997 to 2007 CONCLUSION: IUC use in California is higher than the national average and growing Disproportionately low use among nullips Efforts to inform women of IUC's effectiveness and safety, as well as efforts to ensure that health care providers have the necessary clinical skills, are timely and important. Thompson KM, et al. Womens Health Issues. 2011

25 25 Why is the IUC Underutilized in the United States? Dearth of trained and willing professionals to insert devices Negative publicity about method in ’70s Misconceptions by health care providers and the public Fear of litigation Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997

26 26 Family PACT Provider Practices With IUCs Survey of 1,246 providers with at least one IUC insertion claim in 2005; response rate 65% (n=813) Providers who think an IUC should not be inserted in clients if: – Nulliparous: 50% – Adolescent: 58% – History of ectopic pregnancy: 63% Provider’s concern about PID affected willingness to recommend IUC – “A lot” (29%) – “Some” (61%) Harper C, et. al. OB GYN 2008

27 27 IUC Use By Female Ob/Gyns vs. All Women in the U.S. Population Reference Bureau, 2002.; The Gallup Organization, Female Ob/Gyn Physicians % of population General Population 18% 0.7%

28 28 Why is the IUC Underutilized in the United States? Dearth of trained and willing professionals to insert devices Misconceptions by health care providers and the public Negative publicity about method in ’70s Fear of litigation Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997

29 29 Rate of PID by Duration of IUC Use Rate per 1000 Woman-Years  20 days 21 days - 8 years Duration of Use n=  20,000 women.. Adapted from Farley T, et al. Lancet. 1992;339: Baseline PID risk: 1-2 cases /TWY

30 30 IUCs Do Not Cause PID PID incidence for IUC users is similar to that of the general population Risk is increased only during the first month after insertion Preexisting STI at time of insertion, not the IUC itself, increases risk No reason to restrict use based on sexual behaviors Svensson L, et al. JAMA Sivin I, et al. Contraception Farley T, et al. Lancet Grimes DA, Lancet Hubacher D, et al. Engl J Med 2001

31 31 Why is the IUC Underutilized in the United States? Dearth of trained and willing professionals to insert devices Misconceptions by health care providers and the public Negative publicity about method in ’70s Fear of litigation Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997

32 32 Dalkon Shield

33 33 Dalkon Shield- multi-filament string

34 34 Fertility Rates in Parous Women After Discontinuation of Contraceptive Pregnancies (%) Months After Discontinuation IUCOCDiaphragm Other methods Vessey MP, et al. Br Med J Andersson K, et al. Contraception Belhadj H, et al. Contraception

35 Use of the levonorgestrel releasing- intrauterine system in nulliparous women To evaluate the insertion procedure and continuation rates of the levonorgestrel releasing-intrauterine system (LNG-IUS) in nulliparous women who, due to fear of complications, are often denied this very effective contraceptive method. Marions L, et al. Eur J Contracept Reprod Health Care. 2011

36 Use of the levonorgestrel releasing- intrauterine system in nulliparous women The insertions were considered easy by 72% of inserters * Only 5% of pts were dissatisfied No perforations No pregnancies CONCLUSION: Our results support the current practice in Sweden of offering LNG-IUS routinely to nulliparous women Marions L, et al. Eur J Contracept Reprod Health Care * mostly carried out by midwives

37

38 38 US Medical Eligibility Criteria CategoryDefinitionRecommendation 1No restriction in contraceptive use Use the method 2Advantages generally outweigh theoretical or proven risks More than usual follow-up needed 3Theoretical or proven risks outweigh advantages of the method Clinical judgment that this patient can safely use 4The condition represents an unacceptable health risk if the method is used Do not use the method

39 39 Indications for IUC Use Both IUC products – Long term contraception in fertile women 2010 US Medical Eligibility Criteria  Menarche to age 20 Category-2  Age 20 and older Category-1  Nulliparity Category-2  Parous Category-1

40 SFP on Nullips Lyus R, Lohr P, Prage S, Board of the Society of Family Planning. Use of the Mirena LNG-IUS and Paragard CuT380A intrauterine devices in nulliparous women. Contraception 2010;81:367–71

41 Both IUC Products: US MEC 2010 Category 4 Category 3  Distorted uterine cavity  Post-partum endometritis  Post-abortion endometritis  Malignant GTD or ↑ hCG  Cervical/endometrial cancer  Current GC/CT/purulent cervicitis/PID − Initiate: 4; Continue: 2  Pelvic TB − Initiate: 4; Continue: 3  Postpartum (48h-4 wk)  Benign GTD with ↓ hCG  Increased risk of STIs − Initiate**: 2/3; Continue: 2 ** very high individual risk of exposure to GC or Ct is 3

42 US Medical Eligibility Criteria 2010 Category 4 Category 3 LNG-IUS only Current breast cancer  Breast cancer (> 5 yrs NED)  Liver tumors, severe cirrhosis  Current MI or angina  Migraines with aura  AIDS (ARV drug interactions)  Complicated transplant  Lupus with anti-PL antibody Copper IUC only  Lupus with thrombocytopenia

43 43 Timing of Insertion of Intrauterine Contraception TimingProsCons With menses Ensures patient not pregnantEnsures patient not pregnant Scheduling Scheduling Interim pregnancyInterim pregnancy Any time Convenience Convenience Low expulsion rateLow expulsion rate Must exclude pregnancyMust exclude pregnancy Emergency contraception (Cu T only) Pregnancy preventionPregnancy prevention ConvenienceConvenience Not cost effective if used only for ECNot cost effective if used only for EC Alvarez PJ. Ginecol Obstet Mex O’Hanley K, et al. Contraception

44 Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. Eighteen family planning clinics in China 1963 women requesting EC within 120 hours of unprotected intercourse. followed at 1, 3 and 12 months after insertion of CuT380A. No pregnancies occurred prior to or at the first follow- up visit, making CuT380A 100% effective as emergency contraception in this study. Wu S, et al. BJOG 2010

45 Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. The pregnancy rate over the 12-month period was 0.23 per 100 women 1.5% women experienced a difficult IUD insertion – requiring local anesthesia or prophylactic antibiotics. No uterine perforations occurred. The 12-month postinsertion continuation rate was 94.0 per 100 woman-years. CuT380A is a safe and effective method for emergency contraception. The advantages of CuT380A include its ability to provide effective, long-term contraception. Wu S, et al. BJOG 2010

46 A survey of women obtaining EC: are they interested in using the Cu IUD? 34.0% of 941 said they would be interested in an EC method that was long term, highly effective and reversible. Interested women were not significantly different from non-interested women in relation to age, marital status, education, household income, gravidity, previous abortions, previous STIs or relationship status. 37.5% of those interested or 12.8% of all those surveyed would wait an hour, undergo a pelvic exam to get the method and would still want the method knowing it was an IUD. Only 12.3% of these women could also pay $350 or more for the device. Turok DK, et al. Contraception. 2011

47 A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception. (60%) chose oral LNG and (40%) chose the copper IUD. Turok DK, et al. Contraception. 2010

48 Postpartum IUC Insertion US MEC 2010 Vaginal delivery or C/S Vaginal delivery or C/S Breast-feeding or non-lactating Breast-feeding or non-lactatingLNG-IUSCu-IUD <10 min after delivery of placenta min after delivery of placenta to <4 wks 22 >4 wks post partum 11 Puerperal sepsis 44

49 How Is Postpartum IUC Placement Performed? IUC placement after vaginal delivery – Insert IUC within 10 minutes of placental delivery – Use sponge forceps on cervical lip – 2 nd forceps to place IUC at uterine fundus – Cut string flush with external cervical os – Trim strings at postpartum visit

50 How Is Postpartum IUC Placement Performed? IUC placement at of caesarean section – After delivery of placenta – Manually place IUC at fundus – tuck strings thru cervix – Repair uterus – Trim strings at postpartum visit

51 51 IUC Use During Lactation Effectiveness not decreased No increased risk of – uterine perforation – Expulsion Decreased insertional pain Reduced rate of removal for bleeding and pain LNG comparable to copper T in breastfeeding parameters Chi I-C, et al. Contraception Shaamash AH, et al. Contraception

52 52 Post Abortion IUC Insertion (WHO MEC, Cochrane Review) No difference in complications for immediate versus delayed insertion of an IUC after abortion There were no differences in safety or expulsions after insertion of an LNG-IUC compared to Cu-IUC Expulsion slightly greater when inserted after a 2 nd trimester vs. a 1 st trimester abortion US Medical Eligibility Criteria 2010 – First trimester abortion: USMEC-1 – Second trimester abortion:USMEC-2

53 53 Excellent Time for IUC Insertion- Post Abortion Most women ovulate by 21 days post abortion (range 8-37 days) This is true for 1 st trimester, 2 nd trimester, medical abortion and spontaneous abortion Sober S, et al. Contraception 2010 Donnet ML, et al. Clin Endocrinol (Oxf) 1990 Cameron IT, et al. Acta Endocrinol 1988 R.P. Marrs, et al. Am J Obstet Gynecol 1979

54 54 Excellent Time for IUC Insertion- Post Abortion Of 1.3 million abortions annually in US, about half are repeat procedures 40% of women scheduled for delayed IUC insertion did not return for the procedure Immediate post-abortal IUC insertion is a safe, effective, practical, and underutilized intervention that can reduce repeat unintended pregnancy and repeat abortion by two-thirds P Bednarek, et al N Engl J Med 2011; 364: M Cremer, et al Contraception 2011; 83: Stanek AM, et al. Contraception 2009

55 Why Do A Post-Abortion IUC Placement? Advantages – One procedure rather than two – Less or no pain with insertion, since cervix is dilated – Immediate protection – Reduce repeat unintended pregnancy risk – 2 nd visit often delayed or doesn’t occur Disadvantages – Slightly higher expulsion rate 2 nd tri TAB: 3-10%, 1 st trimester TAB: 5-6% No TAB: 1-4% – Is the decision to use an IUC biased while pregnant? P Bednarek, et al N Engl J Med 2011; 364: M Cremer, et al Contraception 2011; 83:

56 Intrauterine device insertion after medical abortion The day a woman presents for verification of a completed medical abortion may be an ideal time to insert intrauterine contraception 4.1% expulsions No diagnosed pelvic infections, pregnancies, or uterine perforations The continuation rate at 3 months was 80%. Betstadt SJ, et al.Contraception. 2011

57 57 Pre-IUC Insertion Screening Evidence supports no routine screening tests – CT, GC: if high risk sexual behaviors or < age 26 and due for annual screening CT – Pregnancy test: only if pregnancy suspected – Pap smear: only if due for a routine Pap Any indicated screening test can be done on the day of IUC insertion Intrauterine Contraceptives (IUCs), Family PACT Clinical Practice Alert Sufrin C, et al. Contraception 2010 Secura G, et al. Am J Obstet Gynecol 2010 Martínez F, et al. Acta Obstet Gynecol Scand. Faúndes A, et al.Contraception 1998

58 58 Pre-Insertion Guidelines Prophylactic antibiotics – No value for routine administration – May reduce PID in high prevalence GC/CT sites Premedication – NSAID minutes before insertion is common, but no effect on pain or discontinuation – Consider paracervical block if history of cervical os or canal stenosis Martínez F, et al. Acta Obstet Gynecol Scand. Lancet.Lancet Apr 4;351(9108): Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Walsh TWalsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Coulson A, Bernstein G.Grimes DFrezieres RNelson ABernstein LCoulson ABernstein G

59 59 Is A Follow Up Visit Necessary? Practices vary Two studies by WHO in Africa with non-medicated IUCs conclude that a follow-up visit is unnecessary Arguments Pro: – Detect early asymptomatic expulsion – Further counseling – Medico-legal “standard of practice”? Arguments con: – Almost all adverse events have symptoms – Patient knows to return if string cannot be felt

60 60 Post-IUC Insertion Counseling The client should return if – String cannot be located (use barrier method) – Symptoms of pregnancy – Symptoms of infection Pain, deep dysparunia, fever, foul discharge – Sudden unexplained pelvic pain occurs – Excessively heavy bleeding

61 Ectopic pregnancy risk when contraception fails. A review. Furlong, Reprod Med. 2002

62 62 IUC Removal Post Menopause? Menopause – Strings seen: remove – No strings: weigh benefit vs. hazard of removal – Tail-less IUC (e.g., stainless steel coil ring) does not require removal unless requested by the client

63 63 IUCs: Bleeding Days Per Month Luukkainen and Toivonen. 1992;90 Days Months Copper IUC LNG-IUC

64 64 LNG-IUC: “Resting State” Endometrium Lower volume of menstrual bleeding – Shorter, lighter menses – Less iron deficiency anemia – Therapeutic for menorrhagia Less dysmenorrhea – Suppression of endometriosis, adenomyosis BUT… 3-6 months for full effect on the endometrium Spotting is common during this time

65 65 Menstrual Effects of IUCs: LNG-IUC Hypomenorrhea; intermenstrual bleeding Management – Exclude PID, pregnancy, coagulopathy – Supplemental estradiol for 2-3 wks – NSAID’s – If persistent bleeding, check for anemia Remove IUC if abnormal bleeding is unacceptable to patient

66 66 Menstrual Effects of IUCs: Copper IUC Heavier or longer menses (or dysmenorrhea) – Exclude PID, pregnancy, coagulopathy – NSAIDs prophylactically WITH FOOD Pre-emptive use for first 3 cycles Start before onset or with onset of menses for anti- prostaglandin effect – Naproxen sodium 220mg x2 BID (max 1100mg/day) – Ibuprofen mg TID (max 2400mg/day) – If heavy or persistent bleeding, check for anemia Remove IUC if bleeding is unacceptable to patient

67 IUCs: Management of Cramping Mild: recommend NSAIDs Severe or prolonged – Examine for partial expulsion, perforation, or PID – Remove IUD if severe cramping is unrelated to menses or unacceptable to patient

68 Ms B: “I Faint Easily” Ms B is a 25 year old G 0 P 0 woman requesting IUC placement She states that she has had a number of fainting episodes in the past…most recently at the dentist and another during a HPV vaccine injection She has told her PCP about this problem…heart auscultation and an ECG were normal. Are there any special precautions for her IUC placement? 68

69 Lightheadedness and Syncope: Vasovagal Attack Mechanism – Due to bradycardia + peripheral vasodilation – AKA: non-cardiogenic syncope, cervical shock Association with IUC insertion – Syncope in 2% of insertions – Convulsions in 1 per 2,000 insertions – More likely with Pain with cervical manipulation Nulliparity Previous episodes of vaso-vagal fainting Dehydration or NPO

70 Lightheadedness and Syncope: Vasovagal Attack Prodromal symptoms – Lightheadedness, diaphoresis, nausea, anxiety Prodromal physical signs – Facial pallor, yawning, pupillary dilation Convulsive syncope occasionally follows faint – Seizure-like movements – Rapid recovery with little or no post-ictal state – Followed by pallor, headache, weakness

71 Lightheadedness and Syncope: Vasovagal Attack Prevention – Good hydration (electrolyte/ sports drink) – Eat before insertion – Isometric muscle tensing during procedure “Grip your hands together, then pull hard” “Squeeze your leg muscles as hard as you can” Management – Continue isometric muscle tensing – Elevate patient’s legs while remaining supine – If HR remains <60 bpm or convulsive syncope, give atropine 0.4 mg IV push Grubb BP N Engl J Med 2005

72 Lightheadedness and Syncope: Other Causes Hyperventilation – Due to low CO 2 levels (respiratory alkalosis) – Heart rate normal or tachycardia – Treat with shallow breaths or re-breathing bag Local anesthetic toxicity (if cervical block) – CNS: lightheadedness, restlessness, anxiety, tinnitus, tremor, twitch, perioral numbness, visual changes, seizure, respiratory arrest – CV: bradycardia, arrythmia, hypotension 72

73 73 Bleeding from Tenaculum Site Remove tenaculum slowly Apply pressure for at least 60 seconds Chemical cautery − Silver nitrate − Monsel’s solution Suturing very rarely is necessary

74 IUC Complications Absolute risk Comment Perforation1/1,000 Mostly benign Expulsion1-6/100 Most are self-recognized Unsuccessful placement 9/ 100 6% when different device is used after unsuccessful attempt Pregnancy<1/HWY Minimal impact if removed early in pregnancy PID1-2/TWY Same as gen’l population HWY: per 100 women per year TWY: per 1,000 women per year Sivin I, Stern J.Fertil Steril 1994

75 IUC Complications Absolute risk Comment Perforation1/1,000 Mostly benign Expulsion1-6/100 Most are self-recognized Unsuccessful placement 9/ 100 6% when different device is used after unsuccessful attempt Pregnancy<1/HWY Minimal impact if removed early in pregnancy PID1-2/TWY Same as gen’l population Sivin I, Stern J.Fertil Steril 1994

76 Signs of Possible Complications Symptom Possible Explanation Severe bleeding or abdominal cramping 3–5 days after insertion Perforation, infection Irregular bleeding and/or pain every cycle Dislocation or perforation Fever, chills, unusual vaginal discharge Infection more…

77 Signs of Possible Complications SymptomPossible Explanation Pain during intercourse Infection, perforation, partial expulsion Missed period, other signs of pregnancy, expulsion Pregnancy (uterine or ectopic) Shorter, longer, or missing threads Partial or complete expulsion, perforation

78 78 Genital Tract Infections If cervical or vaginal infection diagnosed – IUC removal not necessary – Treat infection – Counsel re: prevention of STI transmission If PID diagnosed – IUC removal usually not necessary – Treat infection – Recommendations to remove IUC are not evidence-based – Consider removal if no improvement hours after starting treatment Penney G. J Fam Plann Reprod Health Care WHO. Selected Practice Recommendations for Contraceptive Use. 2004

79 79 Actinomyces-Like Organisms (ALO) Actinomyces israelii has characteristics of both bacteria and fungus; part of GI flora May asymptomatically colonize the frame of the IUC, which in itself is not dangerous Very small percentage of women with IUC + actinomyces will develop pelvic actinomycosis – Presentation is similar to severe PID Women with ALO on Pap smear – Should be examined to exclude PID – If none, don’t treat actinomyces or remove IUC

80 Uterine Perforation More likely to occur in relation to – Posterior uterine position – Extreme flexion – Skill/experience of provider – Insertion 2 days-4 weeks after childbirth Typical location is midline at uterine fundus…if so, perforation often is asymptomatic, benign Suspect if sounding is much deeper than expected 80 Grimes, et al. Cochrane Library, 2001, Issue 2. Markovitch O, et al. Contraception 2002 Caliskan E, et al. The European Journal of Contraception and Reproductive Health Care 2003 Harrison-Woolrych M, et al. Contraception 2003;

81 If before insertion of IUC, stop procedure If during insertion of IUC, remove IUC Monitor for 30 min for excessive bleeding, pain Provide alternative method of contraception Can insert another device after next menses Management of Uterine Perforation 81

82 Prevention of Uterine Perforation Why sound the uterus at all? – Determine the “pathway” to the fundus – Preliminary dilation of the internal os – Establish depth to fundus to set flange – Ensure depth within 6-10 cm limits Bend sound to mimic uterine flexion Brace fingertips on speculum to achieve control of force while advancing the sound EMB device can be used instead of metal sound Open IUC package after sounding completed 82

83 83 IUC Expulsion Occurs in 1-10% IUC insertions within first year Risk of expulsion related to – Provider’s skill at fundal placement – Age, parity, BMI,uterine configuration – Time since insertion (↑ within first 6 mos) – Timing of insertion (menses, postpartum, post- abortion) Asymptomatic expulsion often presents with an (unanticipated) pregnancy Partial expulsion may present with – Pelvic pain, cramps, intermenstrual bleeding – Pregnancy P Bednarek, et al N Engl J Med 2011; 364: M Cremer, et al Contraception 2011; 83:

84 84 Missing IUC String: Diagnosis Possibilities… – Expulsion, pregnancy, embedment, translocation Initial management – Probe for strings in cervical canal  Cytology brush to tease from canal  Endocervical speculum or forceps – Rule out pregnancy – Prescribe back-up contraceptive method until intrauterine location is confirmed Prabhakaran S. et, al. Contraception.2011

85 85 Missing IUC String: Management No IUC string in canalNo IUC string in canal Pregnancy test negativePregnancy test negative Extracted + initial UTZ Attempt extraction Desiresremoval Embedded Not felt Desiresretention UTZKUB In Situ Absent KUB Op hysteroscopy Present Translocated Absent ExpelledExtracted AbsentAbsentPresent UTZ Absent Translocated In Situ OR

86 86 Missing IUC String: Treatment In situ (intrauterine) placement: desires continuation In situ (intrauterine) placement: desires continuation – Leave in place for remainder of IUC lifespan In situ placement: desires removal In situ placement: desires removal – Use straight or “alligator” forcep, + simultaneous real time pelvic ultrasound – Crochet hook best for circular IUCs; less helpful with T-shaped IUCs – If unsuccessful, extract via operative hysteroscopy Translocation (IUC in peritoneal cavity) Translocation (IUC in peritoneal cavity) – Extract via operative laparoscopy

87 87 Pregnancy With IUC In Situ Determine site of pregnancy (IUP or ectopic) Determine site of pregnancy (IUP or ectopic) If intrauterine pregnancy confirmed If intrauterine pregnancy confirmed – Termination planned: await procedure – Continue pregnancy: remove IUC if strings visible – Removal decreases risk of spontaneous abortion, premature delivery Retention of IUC (if strings not visible) Retention of IUC (if strings not visible) – Increase surveillance for SAB, pre-term birth – No greater risk of birth defects (extra-amniotic)

88 88 Family PACT IUC Policy: Purchase and Records IUCs must be FDA-approved devices, labeled for US use, and obtained from FDA approved distributors Providers must record the lot number in the med record and keep a written or electronic log of all IUCs inserted for at least 3 years from insertion Maintain invoices > 3 years from date of invoice Patients must be provided with a record of the dates of insertion and expiration

89 89 Billing Instructions for IUCs Primary Diagnosis Codes S401: Evaluation prior to initiation of the method, whether or not the IUC is inserted that day – Use S401 when performing the insertion of the first IUC for this client S402: Maintain adherence and surveillance for a current user of an IUC, whether or not the client is new to the provider – Use S402 when replacing an IUC with another of the same type or a different type – Both insertion and removal may be billed on the same date of service

90 90 Insertion – CPT 58300: Insertion of IUC – ZM: Insertion supplies – Kit: X1522 (ParaGard) or X1532 (Mirena) – E&C: contraceptive counseling visit Removal – CPT 58301: Removal of IUC – ZM: Removal supplies – E&C: contraceptive counseling visit Billing Instructions for IUCs Insertion or Removal Procedures

91 91 IUC Complication Coverage New Family PACT benefits for IUCs – CPT-4 code 76857: Ultrasound, pelvic (nonobstetric) – CPT-4 code 76830: Ultrasound, transvaginal – Billing requirements for code are revised 3 codes billed in conjunction with primary diagnosis code S402 and secondary diagnosis code V45.51 (intrauterine contraceptive device). A Treatment Authorization Request is not required. S4032 will no longer be a valid Family PACT PDC effective for dates of service on or after June 1, 2011.

92 92 IUC Complication Coverage IUC complications – S403 Vaso-vagal episode – S4031Pelvic infection (secondary to IUC) – S4032“Missing” IUC- no longer a valid code – S4033Perforated or translocated IUC Covered complication services include – Hysteroscopy, dilation and curettage – Laparoscopy/ laparotomy All complication services must be approved by TAR Please consult familypact.org

93 93 IUC Insertion Practicum Insertion of LNG-IUC Insertion of Cu-T IUC The “Difficult” IUC Insertion

94 94 Steps for IUC Insertion Perform bimanual pelvic exam to determine anterior or retro- flexion Inspect cervix for mucopus Cleanse cervix with antiseptic Use of sterile gloves vs. “no-touch” technique Apply tenaculum – Routine vs. selective local anesthetic injection – Hold hand in palm-up position – “Squeeze” closed; don’t “snap” ratchet – Horizontal or vertical application (purchase) Routine vs. selective use of cervical block

95 95 Steps for IUC Insertion Sound the uterus – Purposes  Determine the “pathway” to the fundus  Preliminary dilation of the internal os  Establish depth to fundus to set flange  Ensure depth within 6-9 cm limits – Bend sound to mimic uterine flexion – Brace fingertips on speculum to achieve control of force while advancing the sound – EMS* device can be used instead of metal sound EMS*: endometrial sampling

96 96 Mirena: The Inserter “Never let go of the Slider!!”

97 97 1. Open sterile package 2. Release the threads 3. Make sure the slider is ….in the furthest position ….away from you 4. Check that the arms of the IUC are horizontal Steps for Mirena Insertion* * Excerpted from package insert

98 98 5.Pull on both threads to draw IUC system into insertion tube 6.Both knobs at ends of IUC arms are now within the inserter Steps for Mirena Insertion*

99 99 7. Fix threads tightly into the cleft at near end of inserter shaft Steps for Mirena Insertion*

100 Set upper edge of movable green flange to the depth of uterine sound Steps for Mirena Insertion*

101 Hold slider with forefinger, or thumb, firmly in furthermost position 10. Move inserter thru cervical canal until flange is about cm from cervix - allows sufficient space for IUC arms to open Steps for Mirena Insertion*

102 While holding inserter steady, release arms of IUC by pulling slider back until it reaches the raised mark on inserter

103 Push inserter gently until flange touches cervix. The IUC should be in fundal position Steps for Mirena Insertion*

104 Pull down on slider all the way; threads will uncleat automatically and release IUC system Double check that the strings are uncleated before withdrawing the inserter Steps for Mirena Insertion*

105 Remove inserter and cut threads about 2 to 3 cm from cervix 15. Measure and record in patient’s chart 16. Have patient feel for IUC threads Steps for Mirena Insertion*

106 106 ParaGard Insertion* Load arms into inserter * Excerpted from package insert

107 107 ParaGard Insertion Load arms into inserter

108 108 ParaGard Insertion Advance insertion tube to fundus Fundal resistance should be coincident with the marker reaching the exocervix

109 109 ParaGard Insertion Pull back on inserter tube while holding white rod steady to deposit IUC in cavity Most important step

110 110 ParaGard Insertion Push inserter tube until resistance to seat the arms of the IUC in the fundus

111 111 ParaGard Insertion Withdraw the white rod while holding inserter tube steady

112 112 ParaGard Insertion Slowly withdraw the inserter from the cervical canal Trim threads to 3-4 cm. Optional Repeat bimanual exam or perform ultrasound to check placement

113 113 IUC Insertion: Tricks of the Trade A Clinical Update on Intrauterine For pain management – Oral NSAID Naproxen sodium mg Ibuprofen mg – Instill lidocaine in uterine cavity with an endometrial sampler – The sampler can be used instead of sound to measure depth of uterus more…

114 114 IUC Insertion: Tricks of the Trade A Clinical Update on Intrauterine To visualize cervix – Use large speculum – If vaginal walls obscure cervix, cut off end of condom or finger of a glove and slip over metal speculum – Get better light For women with narrow cervical canal – Misoprostol 400 mcg SL 1+ hours before insertion

115 115 Reduce expulsion rate by waiting for strings to be released from cleft before withdrawal OBG Management | Vol. 21 No. 2 | February 2009

116 116 What Should I Do if the LNG-IUC Isn’t at the Fundus? There can be significant migration of the LNG- IUC within the uterine cavity Fundal placement insures that the tail strings will be long enough to remove the device A device that settles within the lower uterine segment is still effective Removal of the device is necessary only if – A portion of it protrudes from the cervix, or – There is excessive cramping with a low-lying IUC OBG Management | Vol. 21 No. 2 | February 2009

117 117 What Should I Do if the Cu 380A Isn’t at the Fundus? Fundal placement is necessary for optimal efficacy A copper IUC in the lower uterine segment is less effective Removal of the device and re-insertion of a new device at the fundus is necessary to insure efficacy Do not “push” a partially expelled or low lying device up to the fundus

118 118 Intervention Steps in the “Difficult IUC Insertion” Use greater outward traction on the tenaculum to minimize canal-to-endometrial cavity angulation Place paracervical or intracervical block to relax cervical smooth muscle and reduce pain Use os finder device, if available Dilate internal os with metal dilators to #13F (4.1 mm) If unsuccessful, return at a later date with use of misoprostol cervical priming

119 119 Os Finder Device Cervical Os Finders (Disposable Box/25) $ Cervical Os Finder Set (Reusable Set of 3) $ Pratt Dilators

120 120 Paracervical Block Target is uterosacral ligaments Inject at reflection of cervico-vaginal epithelium 2 (5, 7 o’cl) or 4 sites (4,5,7,8 o’cl) submucosally to depth of 5 mm Use spinal needle or 25g, 1 ½” needle + extender Moore-Graves speculum allows for more movement Tips – Start with ½-1 cc. at tenaculum site – Disguise pain of needle insertion with cough – WAIT 1-2 minutes for set up before procedure

121 121 Paracervical Block X X X 5 o’clock 7 o’clock

122 122 Paracervical Block X X 5 o’clock 7 o’clock X X X 6 o’clock

123 123 Intra-cervical Block Targets the paracervical nerve plexus 1 ½ inch 25g needle with 12 cc “finger lock” syringe Inject ½- 1 cc. local anesthetic at 12 o’clock, then apply tenaculum Angulate needle at the hub to 45 o lateral direction At 3 or 9, insert needle into cervix to the hub 1 cm lateral to external os, aspirate Inject 4 cc of local, then last 1 cc while withdrawing Rotate barrel 180 o, then inject opposite side

124 124 Intracervical Block X 5 o’clock 7 o’clock X 6 o’clock X 9 o’clock 3 o’clock

125 Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women Nulliparous women 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. No significant differences in patient-reported pain with IUD placement (misoprostol 65 mm, placebo 55 mm) at any other time point. The misoprostol group reported significantly more preinsertion nausea (29% vs. 5%) and cramping (47% vs. 16%) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported. CONCLUSION: Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects. Edelman AB, et al. Contraception. 2011

126 80 nulliparas treated 1 hour prior to IUD insertion – Misoprostol 400 mcg SL and diclofenac 100 mg – Diclofenac 100 mg PO alone (control group) Findings – Insertion considered easier by the provider with misoprostol than control group – Pt pain scores no different in the two groups – Most side effects equal Shivering, diarrhea more common in misoprostol group Saav I et. al., Human Reproduction 2007; 22, (10):

127 Misoprostol for IUC Insertion Conclusion – Misoprostol facilitates IUD insertion and reduces the number of difficult and failed attempts of insertions in women with a narrow cervical canal 127 Saav I et. al., Human Reproduction 2007; 22, (10): 2647

128 Prophylactic misoprostol prior to IUD insertion in nulliparous women RCT, nulliparous women, 18–45 years old – MPL 400 mcg bucally or placebo 90 min prior – 36 women completed the study Findings – MPL group a trend toward a more painful insertion – Ease of placement was no different between groups – MPL group had more pre-insertion nausea and cramping than the placebo group (50% vs. 16%) – No reported expulsions Shaefer E et al, Contraception 2010

129 Misoprostol for IUC Placement Take It Home Misoprostol works well to soften and dilate the cervix in pregnant women Studies in non pregnant women having GYN procedures (hysteroscopy, EMB ) have mixed results MPL prior to IUC placement is often recommended But Little evidence to support a clear benefit of this practice Some evidence that it may be harmful It should not be accepted as a “standard practice” yet

130 Ms D: “I Have Fibroids” Ms D is a 35 year old G 0 P 0 woman who is seen for contraceptive counseling Over the past 2 years, her periods have been heavier and longer than previously Bimanual exam: Irregular 12 week size uterus LNG-IUS chosen for contraception and bleeding control Clinical dilemmas… – LNG-IUS control of fibroid-related bleeding – Technical IUC insertion issues with uterine fibroids

131 131

132 LNG-IUS and Fibroids Small studies with mixed results – Mercorio (2003): 75% persistent menorrhagia – Starczewski (2000): 92% reduced bleeding Recommendations – Off-label use; may violate precaution regarding cavity depth and distortion of uterine cavity – Reasonable to attempt treatment with Mirena – Documentation of informed consent content a must 132

133 Tips for IUC Insertion in Women with Fibroids Determine fibroid location by ultrasound – Fundal fibroids (intramural, sub-serous) that do not distort uterine cavity do not preclude IUC use – Large sub-mucous fibroids, especially in lower uterine segment, contraindicate IUC use – Evaluate for other pathology, e.g., polyp Ultrasound guidance may facilitate safe placement No data on efficacy, but probably not compromised with LNG-IUS or with Cu-T if fundal placement 133


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