SOM - State of Michigan



INTRAUTERINE DEVICE (IUD)DEFINITIONThere are five FDA approved intrauterine contraceptive devices available in the U.S. The Copper T380A IUD (ParaGard) is approved for up to 10 years; evidence-based use supports 12-20 years. It has a first-year failure rate of 0. 5% to 0.8%; 1.4 to 2.2 failure rate at 7 years and its 12-year cumulative failure rate is 2.2%. The 52 mg levonorgestrel-releasing IUDs-Mirena is approved for up to 5 years: evidence-based use supports 7 years. It has a first-year failure rate of 0.1-0.2%, a 5-year failure rate of 0.5-1.1% and a 7-year failure rate of 0.5%. Liletta is approved for up to 6 years; evidence-based use supports 7 years. It has a first-year failure rate of 0.1-0.2%, a 5-year typical use failure rate of less than 1%.0.5-1.1% and a 7-year failure rate of 0.5%.The 19.5 mg levonorgestrel-releasing IUD- (Kyleena) is approved for up to 5 years. It has a 5-year failure rate of 1.1+/- 0.5%.The 13.5 mg levonorgestrel-releasing IUD- (Skyla) is approved for up to 3 years of use. It has a first-year failure rate of 0.48% and 0.9% over 3 years. SUBJECTIVEMust include:LNMP and menstrual history. Document any unprotected intercourse in last 5 days.Medical and sexual history update with special attention to reconfirm IUD candidacy.Do not insert an IUD until a minimum of 4 weeks after full term/or second trimester delivery or until uterus fully involuted. An IUD may be inserted immediately after first trimester abortion or pregnancy loss.Review of contraindications and risks:Note: All CDC category 4 conditions– (Unacceptable risk for method use). Use caution with CDC category 3 conditions- (Risks outweigh advantages for method use) individualized management must be based on protocols approved by the Medical Director or clinic physician. Pregnancy (CDC 4)Postpartum puerperal sepsis (CDC 4) (in the past 3 months)Post-septic abortion (immediate) (CDC 4) (in the past 3 months)Ischemic heart disease (current and history of) (LNG continuation is CDC 3)Systemic Lupus Erythematous- Positive (or unknown) antiphospholipid antibodies (LNG CDC 3)Systemic Lupus Erythematous with severe thrombocytopenia (CU-IUD initiation CDC 3)Gestational trophoblastic disease -persistently elevated -hCG levels or malignant disease, with evidence or suspicion of intrauterine disease (CDC 4)Unexplained vaginal bleeding (initiation CDC 4)Breast cancer (current, LNG CDC 4) (past and no evidence of current disease for 5 years, LNG CDC 3)Distorted uterine cavity or other anatomical abnormalities (CDC 4)Cervical cancer (initiation CDC 4)Endometrial cancer (initiation CDC 4)Pelvic Inflammatory disease – current (CDC 4)Current untreated purulent cervicitis, chlamydial infection or gonorrhea (initiation CDC 4; continuation is CDC 2)Cirrhosis (severe-decompensated) (LNG CDC 3)Liver tumors (benign hepatocellular adenoma or malignant hepatoma) (LNG CDC 3)Solid organ transplantation- complicated (initiation CDC 3)Pelvic tuberculosis (initiation CDC 4) (continuation CDC 3)The following are contraindications found in the manufacturers Package Insert:Known or suspected allergy to copper (Copper IUD only) (PI)History of Wilson’s Disease (Copper IUD only) (PI)Small uterine cavity with sounding less than manufacturer’s recommendation Suspected or known uterine perforation occurring with the placement of a uterine sound during the current insertion procedureOBJECTIVEMust include:Blood pressure – if elevated follow agency protocol for hypertension. Normal Pelvic Exam (bimanual and speculum exams)Complete uterine involution is needed following pregnancy, unless placing immediately following pregnancy loss or placing immediately post-partum.If placing IUD immediately following pregnancy loss, must have uterus evacuated of all products of conception, no signs of infection and no excessive, ongoing bleeding.If placing, must have uterine depth consistent with sounding of:Kyleena: 28 x 30mmLiletta: 5.5 cmMirena: 6.0-10 cm.ParaGard: 6.0-9.0 cm.Skyla: 28 x 30mmLABORATORYNo routine laboratory tests needed for IUD placementMay include based on indication:Hgb/Hct if recent history of excessive menstrual blood loss or anemia. Pregnancy test if client at risk. If indicated by age, screening guidelines, sexual history or symptoms, perform needed tests to rule out GC or chlamydial cervicitis or trichomonas vaginitis.ASSESSMENTFor a client who desires long-term continuous contraception with a highly efficacious method.PLANIf possible, place the IUD at this visit. If IUD not placed during this visit, insure she has an interim birth control method and tell client when to return for placement according to the type of IUD she desires. Select IUD-Refer to CDC Medical Eligibility Criteria to determine if any category 3 or 4 contraindications exist. If no contraindications to one type exists, consider the following to help select between copper and LNg IUD: Consideration for Copper IUD:Avoidance of exogenous hormonesContinuation of normal bleeding patternDesire for longer-term contraceptionNeed for emergency contraceptionConsider if history of progestin-related side effects with prior birth controlDysmenorrhea or menorrhagia are relative contraindication as these may worsen with the copper IUDConsiderations for LNg IUD:Reduction of menstrual bleeding and anemiaPossible amenorrheaReduction in dysmenorrheaTreatment of endometriosis-related pelvic painReview client product information brochure with client, answer all her questions, obtain her informed consent and have her sign all appropriate forms. Place forms into client’s record.Premedication has not been found to decrease discomfort of IUD placement, but may be indicated in the following situations:NSAIDs (Ibuprofen 400-600mg orally every 6 hours) to reduce cramping after placement.Paracervical block if client has history of vasovagal reaction or cervical stenosis.If client found to have BV, treat with systemic not topical antibiotics (See Bacterial Vaginosis protocol). No need to delay IUD placement, but reinforce the importance of taking her antibiotics.If no recent pregnancy, place IUD according to manufacturer’s instructions with close attention to aseptic technique. Important elements include:Gently place tenaculum on cervical lip to straighten axis of uterus and to stabilize uterus. Apply traction on tenaculum to reduce risk of perforation.Careful uterine sounding to confirm that client is candidate for her desired IUD:Kyleena - large enough to accommodate IUDLiletta - minimum of 5.5 cm Mirena - 6.0-10.0 cm.ParaGard - 6.0-9.0 cm.Skyla - large enough to accommodate IUDOpen IUD package, load IUD and place IUD following manufacturer’s instructions.Trim strings to 3-4 cm from cervical os. Write procedure note which records uterine position and size, depth of uterine sounding, depth to which IUD placed, and length to which the strings trimmed, how well the client tolerated the procedure, as well as any complications that may have been encountered during the procedure. Document IUD type, lot number and expiration date.Instruct client to return to clinic for routine well woman care and earlier PRN problems with her IUD. No routine post-placement visit needed.Provide backup method for 7 days if LNG IUD placed at any time other than specified (e.g., within 7 days of LMP, delivery or time of hormonal method change).Unless client has contraindications to use of NSAIDs, advise use as needed for problem with cramping or bleeding. Typical recommendation: Ibuprofen 400-600 mg orally every 6 hours when needed for cramping or heavy bleeding. Other NSAIDs at equivalent doses may be used.PLACEMENTSchedule Copper IUD (ParaGard) placement any time in the cycle provided a negative urine pregnancy test.Placement after completion of menses may reduce early expulsion risk. If possible, avoid placing IUD during heavy menstrual flow days.Copper IUD is effective as post-coital emergency contraceptive for up to 5 days after exposure. May place a new IUD (copper or hormonal one) immediately after removing an existing IUD, if she is a candidate for her desired new IUD.Labeling now supports placement immediately after an abortion or delivery. If not inserted at time of delivery it is best to wait until after 4 weeks to lessen expulsion rate.Schedule a levonorgestrel IUD placement any time during the menstrual cycle provided reasonable assurance exists the patient is not pregnant: Within first 7 days of the start of her last normal menses. To reduce early expulsion rates, try to avoid placement on heavy flow days.Has not had intercourse since her last normal menses.Is using a reliable method of contraception correctly and consistently.Is ≤7 days from induced or spontaneous abortionIs ≤4 weeks post-partumIs ≤6 months post-partum, amenorrheic, and exclusively breast feeding If placement is desired at any other time in cycle or under different conditions, perform a urine pregnancy test and have her use abstinence or a back-up method for 7 days following IUD placement. If unprotected intercourse occurred within the last 120 hours and choosing LNG-IUD, offer ECPWomen switching from OCs, advise completion of pill pack, especially if IUD placed during the last week of active pills.May place new IUD immediately after removal of existing IUD if she is still candidate. Advise 7 days of abstinence or use of a backup method following removal of a copper IUD with replacement by a LNg IUD. Consider EC if she has had recent intercourse and the IUD has been in place longer than the manufacturer’s recommendation or she is having a copper IUD replaced with an LNG IUD. None of the LNG-IUD products are a post coital contraceptive.Labeling now supports placement immediately after an abortion or delivery. If not inserted at time of delivery it is best to wait until after 4 weeks to lessen expulsion rate.REMOVAL If IUD strings visible:If there are any signs or symptoms of severe cervical infection, PID, or systemic infection provide appropriate systemic antibiotics and administer first dose prior to removal.Remove IUD following manufacturer’s instructions.If IUD string(s) are missing or break during removal attempt, refer to IUD Issues-Missing String(s).If client seeking pregnancy, provide preconception counseling.If client desires contraception:If client has re-qualified for an IUD, you may place another IUD this same visit. If client desires another method, provide it.If client has had intercourse in the last five days and is at risk for pregnancy if IUD removed, offer emergency contraception or delay removal of IUD.Documentation of reason for IUD removal request.If client wants to continue IUD use, but is requesting removal because her IUD has been in place for the number of years for which it is recommended, consult with MD to determine if an off-label extension of years of use is possible.Zika Risk Assessment- As per current CDC guideline- and partner(s)Past travel – where and whenPlans for future travel – where and whenCLIENT EDUCATION Reinforce IUD education, including signs and symptoms of possible IUD complications (e.g. infection, expulsion, perforation, pregnancy).Instruct client to seek urgent care if any symptoms of PID, pregnancy, expulsion or if she experiences heavy vaginal bleeding or severe cramping.Instruct client on recommended removal date based on type of IUDEncourage routine health rm client that Mirena is the most effective medical treatment for heavy menstrual bleeding and can reduce symptoms of endometriosis and problems with anemia. By providing progestin, Mirena also helps reduce the risk of endometrial cancer and precancer, especially in women with anovulatory cycles.Discuss the expected short-term side effects following placement, including unscheduled bleeding and cramping. Advise that many of these symptoms may subside over time.Discuss the intermediate and longer-term effects of each IUD.ParaGard: Monthly bleeding will may increase by an average of 30-50 %, but that increase can usually be reversed by the use of NSAIDs during menses. (See IUD Issues)Mirena:Unscheduled bleeding and spotting may be frequent in the first 4 months of use but will diminish over time.Total blood loss will be significantly reduced with longer use of Mirena.15-24% of women will have no spotting or bleeding at all by 12 months year 1 of use; 10-26% by 2 years of use Some women experience headaches or breast tenderness, especially with early use, but usually the symptoms are only temporary or are due to other causes.Mirena is an effective IUD medical therapy for heavy or prolonged menstrual bleeding. It may also help reduce dysmenorrhea.Skyla:Unscheduled bleeding and spotting may be frequent in the first 4 months of use but will diminish over time.Total blood loss will be significantly reduced with longer use.6% of women will have no spotting or bleeding at all in year 1of use; 10% by 2 years of useSome women experience headaches or breast tenderness, especially with early use, but usually the symptoms are only temporary or are due to other causes.Liletta Unscheduled bleeding and spotting may be frequent in the first 4 months of use but will diminish over time. Total blood loss will be significantly reduced with longer use. 15-24% of women will have no spotting or bleeding at all in year 1 of use; 10% by 2 years of useKyleena Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. 13% of women will have no spotting or bleeding at all by 1 year of use; 20% by 2 years Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.Remind women that the pregnancy protection, non-contraceptive benefits and the side effects disappear almost immediately following IUD removal. Counsel regarding risk of pregnancy or ectopic pregnancy if IUD removed in absence of menses with recent intercourse; tell client IUD no longer protects her from pregnancy. Encourage EC use. See Emergency Contraceptive (EC) protocol.Encourage women who desire IUD removal in order to become pregnant to use folic acid supplements for at least 1-3 months prior to removal or at least prior to conception.Advise women who have IUD removed but are not seeking pregnancy to immediately initiate another effective method. Remind them that the IUD provides no residual contraceptive protection once it is removed.Zika virus education and prevention strategies Avoid traveling to impacted areas Avoiding mosquito bites if traveling to impacted areas Using condoms to prevent transmission of virus Avoiding pregnancy if infected or partner infectedRisk to unborn fetusREFER TO MD/EDAny client who has difficult placement or removal.Any client with elevated blood pressure or US MEC category 3 or 4 conditions not previously evaluated and approved for IUD by MD.Any client who is unstable after uterine perforation or other complication of IUD placement.REFERENCES ACOG Practice Bulletin No. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol. 2011, reaffirmed 2015; 118(1):184-96.Centers for Disease Control and Prevention (CDC). U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Available at Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines. Available at for Disease Control and Prevention. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. Available at Centers for Disease Control and Prevention (CDC). Zika Virus Homepage- Hatcher RA, et al (editors). Contraceptive Technology, 21st Ed. Ayer Company Publishers New York, NY 2018: 157-193, 520-521Kyleena website: Liletta website: website: website: website: Reviewed/Revised 2020 ................
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