u Merck: Nexplanon trainer u Advisory committee: TherapeuticMD u Advisory Committee: Symbiosis Therapeutics Advisory Committee

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1 To IUD or not to IUD Disclosres Merck: Nexplanon trainer Advisory committee: TherapeticMD Advisory Committee: Symbiosis Therapetics Advisory Committee Advisory Committee: Pfizer SHELAGH LARSON, DNP RNC, WHNP, NCMP Objectives 1. KNOW THE HISTORY OF INTRAUTERINE DEVICES 2. UNDERSTAND THE USE OF IUD WITHOUT OF WITHOUT MEDICATION 3. DISCUSS THE DIFFERENCE OF IUDS ON THE MARKET TODAY 4. DEMONSTRATION OF HOW TO INSERT AND REMOVE ALL TYPES OF IUDS. What is an IUD? An intraterine device (IUD) is a device that is placed in the ters to prevent pregnancy. A plastic string is attached to the end to ensre correct placement and for removal. IUDs are an easily reversible form of birth control, and they can be easily removed. An IUD is a form of Long-Acting Reversible Contraception (LARC). What is an IUD The intraterine device (IUD) is the most poplar means of reversible birth control in the world, with 160 million sers. The failre rate of IUDs almost similar to that of tbal sterilization. IUDs demonstrated risk of explsion ranging from 5% to 22%, What an IUD is NOT Incorrectly belief that the principal mechanism of action of IUDs is prevention of implantation of fertilized eggs (abortion) Prevention of fertilization seems to be the dominant mode of action. World Health Organization Scientific Grop: "It is nlikely that the contraceptive efficacy of IUDs reslts, mainly or exclsively, from their capacity to interfere with implantation; it is more probable that they exert their antifertility effects beyond the ters and interfere with steps in the reprodctive process that take place before the ova reach the terine cavity 1

2 History of intraterine devices for contraception History of the IUD Nomads inserted stones in camels ters prior to long jorneys across the desert Hippocrates, is credited with first sggesting that small objects in the hman ters might prevent pregnancy. Late 19 th centry, first precrsors of modern IUDs emerged the Stem Pessary made of metals (gold or silver) or glass. The stem was inserted into the ters In 1909, Dr. Richard Richter in Poland, fashioned the flexible ring with stre material and inserted it into the ters with a notched instrment. By 1930s, tre intraterine devices were being developed, Silk thread wrapped with silver wire 1960, the Lippes Loop, a sinos length of plastic wire that straightened for insertion bt then crved back and forth in the terine The Dalkon Shield, as it was called, had little feet protrding ot on the sides to keep it from being expelled prematrely from the ters. The Dalcon Shield disaster Lippes Loop First distribted in 1962 Intended to remain ntil menopase The problem was that the feet dg into the terine wall and stck. In order to get the device ot, a sper-strong mltifilament string was added, which trned ot to be the perfect highway for germs to travel p into the normally sterile ters By the time the Shield was taken off the market, it was thoght to be responsible for 18 deaths and 200,000 infections or other complications. In a media blitz, the company directed sers to see a physician and offered to pay for exams even if a shield was not fond legal settlement created a $2.5 billion trst fnd to pay victims' claims. Copper T In Erope, A small plastic T wrapped in copper with a nylon filament tail became the international gold standard. It is 20x more effective than the Pill at preventing pregnancy, The copper is toxic to sperm Last p to 2 decades doesn t fit every womb menstral flow and cramps tend to increase by half over the first six months before gradally retrning to pre-insertion levels, isn t a good option for women who have problem periods or who teeter on the edge of anemia. Hormonal IUD Beginning in the 1970s, the next generation of IUD was being developed. Instead of releasing copper ions, this new wave of technology releases a micro-dose of a hormone, levonorgestrel, sometimes fond in birth control pills. decrease cramps and bleeding by 90 % Thin the terine wall so they can be sed to treat endometriosis, allowing some women to avoid hysterectomies 2000 approved in US, at first only for monogamos women who had already had babies. 2

3 Mechanism of Action Hinder ascent of sperm to the fallopian tbes Sterile foreign-body reaction in the terine cavity Celllar and biochemical changes that may be toxic to sperm Pre-fertilization spermicidal action and a postfertilization inhibition of terine implantation. CONTRAINDICATIONS FOR IUD INSERTION pregnancy crrent, recrrent or recent (3 mo) PID or STI perperal or postabortal sepsis severely distorted terine cavity nexplained vaginal bleeding cervical or endometrial cancer gestational trophoblastic disease Copper allergy (for copper IUD) breast cancer (for LNG-IUS) Timing of Insertion: non postpartm patient < 7 days since the start of a normal menses No sexal intercorse since the beginning of the last normal menses Has been sing a reliable method of contraception correctly and consistently < 7 days since a spontaneos or indced abortion < 4 weeks postpartm < 6 months postpartm, amenorrheic since delivery, and exclsively or almost exclsively breast feeding (at least 85% of infant feedings are breast feedings) Uncertain pregnancy? Women who want to begin sing an IUD (C-IUD or LNG-IUD), in sitations in which the health-care provider is ncertain whether the woman is pregnant, the woman shold be provided with another contraceptive method to se ntil the health-care provider is reasonably certain that she is not pregnant and can insert the IUD. Pregnancies among women with IUDs are at higher risk for complications sch as spontaneos abortion, septic abortion, preterm delivery, and chorioamnionitis Copper T (C-IUD) Non-hormonal Intraterine Device Copper T 380 (known as Paragard) which contains 380 sq mm of copper wire and is effective for 10 years. he C-IUD can be inserted at any time if it is reasonably certain that the woman is not pregnant Insert within 5 days of the first act of nprotected sexal intercorse as an emergency contraceptive. If the day of ovlation can be estimated, the can be inserted >5 days after sexal intercorse as long as insertion does not occr >5 days after ovlation. 3

4 Bleeding Irreglarities with C-IUD Use Before insertion, provide conseling abot potential changes in bleeding patterns dring C-IUD se. Unschedled spotting or light bleeding, as well as heavy or prolonged bleeding, is common dring the first 3 6 months, is generally not harmfl, and decreases with contined C-IUD se. Consider an nderlying gynecological problem, sch as C-IUD displacement, an STD, pregnancy, or new pathologic terine conditions (e.g., polyps or fibroids), If an nderlying gynecological problem is not fond and the woman reqests treatment, the following treatment option can be considered dring days of bleeding: NSAIDs for short-term treatment (5 7 days) If bleeding persists and the woman finds it nacceptable, consel her on alternative contraceptive methods, and offer another method if it is desired. Hormonal Intraterine Device LNG-IUD Skyla : the good and bad Skyla 13.5 mg levonorogestrol ; Estrogen free (Actal size: 1.18 ) 3 years Three years Less than 0,9 % pregnancy Smallest IUD in US Estrogen free Increase Risk for ectopic pregnancy Rick for perforation on insertion Increase risk of ovarian cyst,14% Breakthrogh bleeding Mirena/Liletta 52.0 mg(levonorgestrelreleasing intraterine system) prevent pregnancy for as long as yo want for p to 5 years. Indication for women with heavy periods Approved for se as a LARC 2000, menorrhagia 2009 Mirena/Liletta Up to 5 years of contraception Periods over time sally become shorter, lighter or may stop Reversible Estrogen free HCPCS Code J7302 Bleeding and spotting may increase in the first 3 to 6 months and remain irreglar.. Don't se if yo have a pelvic infection, get infections easily or have certain cancers. Less than 1% of sers get a serios infection called pelvic inflammatory disease. 4

5 LNG-IUD Who cannot se LNG-IUD Are or might be pregnant; cannot be sed as an emergency contraceptive Have had a serios pelvic infection called (PID), nless yo have had a normal pregnancy after the infection went away Have an ntreated pelvic infection, now Have had a serios pelvic infection in the past 3 months after a pregnancy if yo or yor partner have mltiple sexal partners Problems with yor immne system Intravenos drg abse Have or sspect yo might have cancer of the ters or cervix Have bleeding from the vagina that has not been explained Have liver disease or a liver tmor Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past Have an intraterine device in yor ters already Have a condition of the ters that changes the shape of the terine cavity, sch as large fibroid tmors Are allergic to levonorgestrel, silicone, polyethylene, silica, barim slfate or iron oxide Relative contraindications inclde risk factors for HIV or STI, HIV seropositive stats, recent (48 hr to 4 wk) childbirth, ovarian cancer benign gestational trophoblastic disease Bleeding Irreglarities (Inclding Amenorrhea) with LNG-IUD Use Irreglar Bleeding (Spotting, Light Bleeding, or Heavy or Prolonged Bleeding) consider an nderlying gynecological problem, sch as LNG-IUD displacement, an STD, pregnancy, or new pathologic terine conditions (e.g., polyps or fibroids). If an nderlying gynecological problem is fond, treat the condition or refer for care. If bleeding persists and the woman finds it nacceptable, consel her on alternative contraceptive methods, and offer another method if it is desired. Amenorrhea Amenorrhea does not reqire any medical treatment. Provide reassrance. If a woman's reglar bleeding pattern changes abrptly to amenorrhea, consider rling ot pregnancy if clinically indicated. If amenorrhea persists and the woman finds it nacceptable, consel her on alternative contraceptive methods, and offer another method if it is desired 5

6 % nintended pregnancy within the first year of se C-IUS 0.8 Typical se 0.6 Perfect se 78 % sing it AFTER 1 YEAR Lng-IUS 0.2 Typical Use 0.2 Perfect Use 80% sing it AFTER 1 YEAR Screening for STI prior to IUD insertion Crrent evidence does not spport rotine screening for STIs in lowrisk women prior to IUD insertion Screening can be performed at the time of IUD insertion, and insertion shold not be delayed. Women with prlent cervicitis or crrent chlamydial infection or gonorrhea shold not ndergo IUD insertion Women who have a very high individal likelihood of STD exposre (e.g., those with a crrently infected partner) generally shold not ndergo IUD insertion. For these women, IUD insertion shold be delayed ntil appropriate testing and treatment occr WHO 2014 Update Women withot STIs ndergoing insertion of modern coppercontaining and levonorgestrel (LNG)-releasing IUDs is associated with only a small transient risk for PID (9.7 per 1000 women years) that exists primarily in the first 20 days following placement Stdy: PID among women with/withot STIs at the time of copperbearing IUD insertion, the absolte risk of PID ranged from 0 5% among women with STIs compared with 0 2% among women withot STIs at insertion Management of the IUD when a C/LNG-IUD User Is Fond To Have PID Treat the PID according to the CDC Sexally Transmitted Diseases Treatment Gidelines. Provide comprehensive management for STDs, inclding conseling abot condom se. The IUD does not need to be removed immediately if the woman needs ongoing contraception. Reassess the woman in hors. If no clinical improvement occrs, contine antibiotics and consider removal of the IUD. If the woman wants to discontine se, remove the IUD sometime after antibiotics have been started to avoid the potential risk for bacterial spread reslting from the removal procedre. If the IUD is removed, consider ECPs if appropriate. Consel the woman on alternative contraceptive methods, and offer another method if it is desired. Management of the IUD when a C/LNG-IUD User Is Fond To Be Pregnant PRE-PROCEDURE: ASSESSMENT AND COUNSELLING Evalate for possible ectopic pregnancy. Advise the woman that she has an increased risk for spontaneos abortion (inclding septic abortion that might be life threatening) and of preterm delivery if the IUD is left in place. The removal of the IUD redces these risks bt might not decrease the risk to the baseline level of a pregnancy withot an IUD. If she does not want to contine the pregnancy, consel her abot options. If she wants contine the pregnancy, advise her to seek care promptly if she has heavy bleeding, cramping, pain, abnormal vaginal discharge, or fever. If the IUD strings cannot be located, it might have been expelled or have perforated the terine wall. Perform sono for location Removing the IUD improves the pregnancy otcome if the IUD strings are visible or the device can be retrieved safely from the cervical canal. informed of the risks of IUD insertion terine perforation ( per 1000 insertions), infection (as discssed above, de mostly to contamination with endocervical bacteria and exposre to STIs), explsion (10% in the first year declining to 6% in the first 5 years) and failre of device; se protection for the first 7 days after insertion Conseling abot potential changes in bleeding patterns dring LNG-IUD se. Unschedled spotting or light bleeding is expected dring the first 3 6 months of LNG- IUD se, is generally not harmfl, and decreases with contined LNG-IUD se. Over time, bleeding generally decreases with LNG-IUD se, and many women experience only light menstral bleeding or amenorrhea. Heavy or prolonged bleeding, either nschedled or menstral, is ncommon dring LNG-IUD se 6

7 Switching from an IUD Insertion of IUD If the woman has had sexal intercorse since the start of her crrent menstral cycle and it has been >5 days since menstral bleeding started, theoretically, residal sperm might be in the genital tract, which cold lead to fertilization if ovlation occrs: Advise the women to retain the IUD for at least 7 days after combined hormonal contraceptives are initiated and retrn for IUD removal. Advise the woman to abstain from sexal intercorse or se barrier contraception for 7 days before removing the IUD and switching to the new method. Advise the woman to se ECPs at the time of IUD removal. NEGATIVE Pregnancy test! Signed Consent; start Time ot procedre Pap, Chlamydia and gonorrhea screen Testing for STIs does not need to be completed before IUD insertion. Cleanse cervix 3x with iodine apply tenaclm at 10 and 2 Sond the ters shold sond to a depth of 6 to 10 cm Slide the marker on the inserter to desired depth Apply gentle traction on tenaclm while inserting References Baer, U. and Barfield, W. (2013). Selected practice recommendations for contraceptive se, 2013: Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition. Division of Reprodctive Health, National Center for Chronic Disease Prevention and Health Promotion: Recommendations and reports. 62(RR05);1-46. Retrieved from Dragoman, M. V., Jatlaoi, T., Nanda, K., Crtis, K. M., & Gaffield, M. E. (2016). Research gaps identified dring the 2014 pdate of the WHO medical eligibility criteria for contraceptive se and selected practice recommendations for contraceptive se. Contraception, 94, Godfrey, E. M. (2015). Helping clinicians prevent pregnancy among sexally active adolescents: U.S. Medical Eligibility Criteria for contraceptive se and U.S. selected practice recommendations for contraceptive se. Pediatric Adolescence Gynecology, 28, Mazmdar, M. D. (n.d.). Intraterine Contraceptive Device (IUCD OR IUD). Retrieved from Spinnato,J.A (March 1997). Mechanism of action of intraterine contraceptive devices and its relation to informed consent. American Jornal of Obstetrics and Gynecology, 176(3), Retreived from: Tarico, V. (2013). A brief history of the IUD: The strange ways we ve tried to stop pregnancy. Alternet. Retrieved from 7