INTRAUTERINE DEVICE (IUD): IDENTIFICATION OF CANDIDATE

DEFINITION

The U.S. Medical Eligibility Criteria (US MEC), are used as a basis for recommendations for this protocol, not the product labeling. There arefourtypes of intrauterine contraceptive devices available in the U.S. The Copper T380A IUD (ParaGard) is effective for at least 10 years.* In typical use, the copper IUD has a first year failure rate of 0.8%; its 10 year cumulative failure rate is 2.7%. The levonorgestrel-releasing IUS-20 mcg/24hr. (Mirena) is effective for 5 years and has a first year and 5 year failure rate in typical use of less than 1%. Mirena offers many noncontraceptive health benefits related to menstrual suppression. The LNG IUS-13.5 mg (Skyla®) is approved for up to 3 years of use(with a first year failure rate of 0.15 per PI). First year failure rate is 0.41%. (Liletta) containing 52 mg levonorgestrel.is approved for up to 3following delivery or following pregnancy loss at any gestational age. The newest levonorgestrel IUD is Kyleena​​ (levonorgestrel-releasing intrauterine system) 19.5 mg is indicated for the prevention of pregnancy for up to 5 years.

*Literature supports 12 to 20 years of use.

SUBJECTIVE

Mustinclude:

1. LNMPandmenstrual history.

2. Documentanyunprotectedcoitusinlast5 days.

Must exclude:

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.

1.Pregnancy (CDC4)

2.Postpartum puerperal sepsis (CDC 4)(in the past 3 months)

3.Post-septic abortion (immediate) (CDC 4)(in the past 3 months)

4.Ischemic heart disease (current and history of) (LNG continuation is CDC 3)

5.Systemic Lupus Erythematous- Positive (or unknown) antiphospholipid antibodies (LNG CDC 3)

6.Systemic Lupus Erythematous with severe thrombocytopenia (CU-IUD initiation CDC 3)

7.Gestational trophoblastic disease -persistently elevated -hCG levels or malignant disease, with evidence or suspicion of intrauterine disease (CDC 4)

8.Unexplained vaginal bleeding (initiation CDC 4)

9.Breast cancer (current, LNG CDC 4) (past and no evidence of current disease for 5 years, LNG CDC 3)

10.Distorted uterine cavity or other anatomical abnormalities (CDC 4)

11.Cervical cancer (initiation CDC 4)

12.Endometrial cancer (initiation CDC 4)

13.Pelvic Inflammatory disease – current (CDC 4)

14.Current untreated purulent cervicitis, chlamydial infection or gonorrhea (initiation CDC 4; continuation is CDC 2)

15.Cirrhosis (severe-decompensated) (LNG CDC 3)

16.Liver tumors (benign hepatocellular adenoma or malignant hepatoma) (LNG CDC 3)

17.Solid organ transplantation- complicated (initiation CDC 3)

18.Pelvic tuberculosis (initiation CDC 4) (continuation CDC 3)

The following are contraindications found in the manufacturers Package Insert (PI):

19.Known or suspected allergy to copper (Copper IUD only) (PI)

20.History of Wilson’s Disease (Copper IUD only) (PI)

21.Small uterine cavity with sounding less than manufacturer’s recommendation

22.Suspected or known uterine perforation occurring with the placement of a uterine sound during the current insertion procedure

OBJECTIVE

Mustinclude:

1. Normalpelvicexam(bimanualandspeculumexams).

2. Completeuterineinvolutionisneededfollowingpregnancy,unlessplacingimmediatelyfollowing pregnancylossorplacingimmediatelypost-partum.

a.IfplacingIUDimmediatelyfollowingpregnancyloss,musthaveuterusevacuatedof all productsofconception,nosignsofinfectionandnoexcessive,ongoingbleeding.

3. Ifplacing,musthaveuterine depth consistent with sounding of:

  1. Kyleena:large enough to accommodate IUD
  2. Liletta: 5.5 cm
  3. Mirena:6.0-10cm.
  4. ParaGard: 6.0-9.0 cm.
  5. Skyla: large enough to accommodate IUD.

LABORATORY

Must include:

1. Hgb/Hctifrecenthistoryofexcessivemenstrualbloodlossoranemia.

2. PatientdoesnotneedanytestingdonetoqualifyforIUDifshehasnosignsorsymptomsof infection. Ifindicatedbyage,screeningguidelines,sexualhistoryorsymptoms,performneeded teststoruleoutGC orchlamydialcervicitisortrichomonasvaginitis.Itisnotnecessarytodelay IUDplacementuntilresultsareavailable.Prompt(within7 days)treatmentwillpreventPIDifthe womandoeshavea cervicalinfectionatthetimeofIUDplacement.

3. Negativeurinepregnancytestifpatienthashad anyunprotectedintercourseatanytimeinhercycle thatcouldresultinpregnancy,orifshehashad anyirregularmensesrecentlyoranysymptomsof pregnancy.

ASSESSMENT

For a woman who desires long-term continuous contraception with a highly efficacious method.

PLAN

  1. SelectIUD. Ifpatienthascopperallergy,Wilson’sdisease,anemia(Hgblessthan10g/dL),excessivemenstrualbleedingorseveredysmenorrhea,sheisa bettercandidatefora LNG-IUS ratherthanforthecopperIUD.Ifsheprefersmonthlybleedingordoesnotwanttousehormones, ParaGardwouldbeabetterchoice.
  2. Instructpatienttoreadandanswerallquestionsonpatientproductinformationbrochure.Answerall ofpatient’squestions.Havehersignthemanufacturer’sconsentformorclinicconsentform.Seemanufacturer’swebsiteforadditionalcopiesofthepatientbrochureandtheconsent formsinherlanguage.
  3. Consideradvisingpatienttotakeanonsteroidalanti-inflammatoryagent1to4hourspriorto IUD/IUSplacementifnotmedicallycontraindicated.ItwillnotreducepainduringIUDplacement, butmayreducecrampingandpainafterwards.
  4. Ifpossible,placetheIUDatthisvisit(SeeIUDPlacementprotocol).IfIUDnotplacedduringthis visit,insureshehasan interimbirthcontrolmethodandtellpatientwhentoreturnforplacement accordingtothetypeofIUDshedesires.
  5. Schedule CopperIUD(ParaGard)placementanytimeinthecyclewhenthewomanisnot pregnant.
  6. Placementaftercompletionof mensesmayreduceearlyexpulsionrisk. Ifpossible,avoid placingIUDduringheavymenstrualflowdays.
  7. CopperIUDiseffectiveaspost-coitalemergencycontraceptiveforupto5daysafterexposure.
  8. MayplaceanewIUD(copperorhormonalone)immediatelyafterremovingan existingIUD,ifsheisa candidateforherdesirednewIUD.
  9. Placementimmediatelyfollowinguncomplicatedfirsttrimesterpregnancylossisanoption.Postpartumwomenandwomenwhoexperiencepregnancylossinsecondorthirdtrimestermay becandidatesforimmediateplacement,butsuchIUDplacementrequiresdifferenttraining,(SeeIUDPlacementprotocol).Mostwomenwillprobablywaituntiluterineinvolutionis complete(usually6-8 weeks).
  10. SchedulealevonorgestrelIUS(Kyleena,Liletta, Mirena, orSkyla,)placementaccordingtothefollowinginstructions foron-labelplacement:
  11. Withinfirst7 daysofcycle.Toreduceearlyexpulsionrates,trytoavoidplacementonheavy flowdays.
  12. Womenwhoarenotcycling(e.g.duetobreast-feedingorDMPA-inducedamenorrhea)may haveplacementatanytimetheyarenotpregnantandhavenothadrecentunprotected intercourse.Advise7 daysuseofabstinenceorback-upmethodafterIUSplacement.
  13. WomenswitchingfromOCs,advisecompletionofpillpack,especiallyif IUSplacedduringthe lastweekofactivepills.
  14. MayplacenewIUSimmediatelyafterremovalofexistingIUSifsheisstillcandidate.Removal isrecommendedon mensesbutifremovedatothertimeincycle,advise7 days ofabstinenceor useofabackupmethodfollowingreplacement.ConsiderECif shehashadrecentintercourse and the IUS has been in place longer than the manufacturer’s recommendation. None of the LNG-IUSproducts are a postcoitalcontraceptive.
  15. Placementimmediatelyfollowinguncomplicatedfirsttrimesterpregnancylossisanoption.Postpartumwomenand womenwhoexperiencepregnancylossinsecondorthirdtrimestermay becandidatesforimmediateIUSplacement,butspecialtrainingisneeded forplacementunder theseconditions,(SeeprotocolIUDPlacement).Mostwomenwillprobablywaituntiluterine involutioniscomplete(usually6-8 weeks). Lilettaor Kyleena–do not insert Liletta or Kyleena until a minimum of 6 weeks after full term/or second trimester delivery or until uterus fully involuted. Liletta and Kyleena may be inserted immediately after first trimester abortion or pregnancy loss.
  16. Ifplacementisdesiredatanyothertimeincycleorunderdifferentconditions,makesurethe patientisnotpregnantandhaveheruseabstinenceora back-upmethodfor7 daysfollowing IUSplacement. If unprotected intercourse within the last 120 hrs and choosing LNG-IUS offer ECP.

PATIENT EDUCATION

  1. ReinforceIUDeducationasdescribedinmanufacturer’sbrochure.ProvideinformationaboutmechanismsofIUD/IUSaction,stresstheimportanceofsafersexpractices,describepossible placementcomplications,andfollow-upneededifproblemsariseafterplacement.Reassurepatient thatasanongoingmethod,all IUDsworkascontraceptives,bypreventingfertilization.
  2. DiscussrisksofIUD/IUSifpregnancyoccurs:ectopicpregnancy;pretermlabor;needforIUD removal if possible; intrauterine levonorgestrel exposure (Kyleena, Liletta, Mirena,and Skyla).
  3. InformpatientthatMirenaisthemosteffectivemedicaltreatmentforheavymenstrualbleedingand canreducesymptomsofendometriosisand problemswithanemia.Byprovidingprogestin,Mirenaalsohelpsreducetheriskofendometrialcancerandprecancer,especiallyinwomenwith anovulatorycycles.
  4. Discusstheexpectedshorttermsideeffectsfollowingplacement,includingunscheduledbleeding andcramping.Advisethatmanyofthesesymptomsmaysubsideovertime.
  5. DiscusstheintermediateandlongertermeffectsofeachIUD.

a.ParaGard:Monthlybleedingwillincreasebyanaverageof30-50%, butthatincreasecan usuallybereversedbytheuseofNSAIDsduringmenses.(SeeIUDComplications: AmenorrheaandAbnormalBleedingprotocol).

b. Mirena:

1)Unscheduledbleedingandspottingmaybefrequentinthefirst4 monthsofuse,butwill diminishovertime.

2)TotalbloodlosswillbesignificantlyreducedwithlongeruseofMirena.

3)20%ofwomenwillhavenospottingorbleedingatallby12monthsofuse.Bythattime, mostotherwomenwillhaveonly1-3daysofspottingamonth.

4)Somewomenexperienceheadachesorbreasttenderness,especiallywithearlyuse,but usuallythesymptomsareonlytemporaryorareduetoothercauses.

5)Mirenaisan effective IUD medicaltherapyforheavyorprolongedmenstrualbleeding.It mayalsohelpreducedysmenorrhea.

c.Skyla:

1)Unscheduledbleedingandspottingmaybefrequentinthefirst4 monthsofuse,butwill diminishovertime.

2)Totalbloodlosswillbesignificantlyreducedwithlongeruse.

3)12%ofwomenwillhavenospottingorbleedingatallby3 yearsofuse.

4)Somewomenexperienceheadachesorbreasttenderness,especiallywithearlyuse,but usuallythesymptomsareonlytemporaryorareduetoothercauses.

d. Liletta

1)Unscheduled bleeding and spotting may be frequent in the first 4months of use, but will diminish over time.

2)Total blood loss will be significantly reduced with longer use.

3)38% of women will have no spotting or bleeding at all by 3 years of use

e. Kyleena

1)Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months.

2)Periods may become shorter and/or lighter thereafter.

3)Cycles may remain irregular, become infrequent, or even cease.

4)Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.

  1. Remindwomenthatthepregnancyprotection,non-contraceptivebenefitsandthesideeffectsdisappearalmostimmediatelyfollowingIUDremoval.
  2. Zika virus education and prevention strategies
  1. Avoid traveling to impacted areas
  2. Avoiding mosquito bites if traveling to impacted areas
  3. Using condoms to prevent transmission of virus
  4. Avoiding pregnancy if infected or partner infected

1)Risk to unborn fetus

REFER TO MD

1. ConsultwithMDaboutmanagementofwomendesiringintrauterinecontraceptiveplacementdirectedby localprocedures.

REFERENCES

  1. ACOGPracticeBulletinNo.121:Long-actingreversiblecontraception:Implantsandintrauterine devices.ObstetGynecol.2011, reaffirmed 2015; 118(1):184-96.
  2. CentersforDiseaseControlandPrevention(CDC).U.S.MedicalEligibilityCriteriafor ContraceptiveUse,2016.Availableat
  3. CentersforDiseaseControlandPrevention.SexuallyTransmittedDiseasesTreatmentGuidelines.Availableat
  4. CentersforDiseaseControlandPrevention.U.S.SelectedPracticeRecommendationsforContraceptiveUse,2016. Available at
  5. Centers for Disease Control and Prevention (CDC). Zika Virus Homepage-
  6. HatcherRA,etal(editors).ContraceptiveTechnology, 20thEd.NewYork:ArdentMedia.2011 147-192.
  7. Kyleena website:
  8. Liletta website:
  9. Mirenawebsite:
  10. ParaGardwebsite:
  11. Skyla website:

Reviewed/Revised 2017

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