Intrauterine Device (IUD) Or Intrauterine System (IUS)

Intrauterine device (IUD) or Intrauterine system (IUS) (March 5, 2014)

I. Background A. The ParaGard IUD, Mirena IUS, and Skyla IUS are highly effective methods of intrauterine contraception. The IUD/IUS is not abortifacient; it prevents fertilization. B. The ParaGard IUD was introduced in the United States in 1988. The ParaGard IUD is made of polyethylene with barium sulfate added to allow x-ray visibility. The vertical stem is constructed with fine copper wire casing and horizontal arms which have copper sleeves. Two strands of monofilament polyethylene comprise the IUD strings which facilitate removal. The approved duration of use of this device is 10 years. C. The mechanism of action of the ParaGard device includes an increase in copper ions, enzymes, prostaglandins, and white blood cells in both uterine and tubal fluids. These events impair sperm function and prevent fertilization. D. The Mirena IUS initially releases 20 mcg levonorgestrel daily directly into the endometrial cavity. The amount of levonorgestrel released declines to a rate of approximately 14 mcg per day after 5 years which is the approved life span of this device. E. The Mirena levonorgestrel system mechanism of action includes thickening of cervical mucus, alteration of the endometrium preventing implantation of fertilized ovum, and alteration of uterotubal fluids impairing sperm migration. The Mirena has some anovulatory effect due to systemic absorption of levonorgestrel. F. The Skyla IUS is a progestin-containing intrauterine system indicated for prevention of pregnancy up to 3 years. G. The Skyla IUS contains 13.5 mg of levonogestrel released at a rate of 14 mcg/day after 24 days. This rate declines to a rate of approximately 5 mcg/day after 3 years. H. The Skyla mechanism of action includes thickening of the cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the the endometrium. I. Actinomyces is a common colonizing bacterium in a variety of body sites including the vagina. Pap smears can sometimes detect this colonization, but the finding is not common. Though this colonization generally does not lead to invasive infection, sometimes such infections occur. Pelvic actinomycosis is a rare but serious condition. J. The relationship between Actinomyces found on a Pap smear in the asymptomatic IUD/IUS user and the development of a pelvic actinomycosis infection is not clear. Less than half of the women with Actinomyces on Pap smear truly have the infection, and those that do usually have lower tract colonization only. K. There are many different opinions about the management of women with actinomyces and IUD/IUS. Some experts would simply leave the IUD/IUS in place if the woman is asymptomatic. Others would remove it. Many times, simply removing the IUD/IUS in an asymptomatic woman is enough to clear the patient of the bacteria. However, the conservative approach of treating with an antibiotic is also an option. Actinomyces, which is an anaerobic bacterium, is sensitive to penicillin, erythromycin, and tetracycline.

II. Arranging for IUD/IUS insertion A. Though the actual insertion of the IUD/IUS will be done by the Nurse Practitioner, the RN seeing the patient can do the Pre-insertion Evaluation if a patient is interested in a long-acting method when being seen on a routine Family Planning or STD exam visit. B. Process (further details for the following items are in section III.A.1-5 below): 1. Screen for contraindications to the method using the IUD/IUS Screening Form 2. Counsel patient on the method (see section IV. below) 3. Obtain laboratory as needed a. GC and Chlamydia tests within 60 days; may be done at the time of insertion. b. Pap test which rules out cervical malignancy within the normal screening interval for the client. If the patient is uninsured and is due for a Pap test, a Pap test may be done at the time of insertion. An IUD/IUS should not be initiated for a client who has cervical cancer. C. Consideration may be given to a same-day IUD/IUS insertion for the patient if pregnancy and contraindications to the IUD/IUS are ruled out and clinic scheduling will allow.

III. Evaluation

A. Pre-insertion Evaluation: See below.

1. History: per Title X Guidelines, including assessing for a. Absolute contraindication = refrain from providing in the following conditions: i. Pregnancy or suspicion of pregnancy ii. Distorted uterine cavity iii. Acute PID or a current history suggesting high risk of PID iv. Pelvic infection in the past 3 months including postpartum or postabortal endometritis, PID, or genital actinomycosis v. Untreated endocervical gonorrhea, chlamydia, or mucopurulent cervicitis, or a history of treated gonorrhea or chlamydia within the past three months without a documented test-of-cure vi. Known or suspected uterine or cervical malignancy vii. Genital bleeding of unknown etiology viii. Previously placed intrauterine contraceptive that has not been removed ix. Gestational trophoblastic disease with persistently elevated B-hCG levels or malignant disease x. ParaGard only: I) Wilson’s disease or allergy to copper xi. Mirena only: I) Known breast cancer A) Acute liver disease or liver tumor B) History of PID without intervening uterine pregnancy 2. Relative contraindication = exercise caution in the following situations. Patient must be provided information regarding additional health risks to her and this must be documented. These patients must be managed by a physician: a. Women who are immunocompromised. Women with AIDS b. Previous problem with IUD/IUS – document problem c. Difficulty obtaining emergency follow-up care and treatment for PID d. Past history of severe vasovagal reactivity or fainting e. Uterine cavity size < 6.0 cm f. If a woman has a very high individual likelihood of exposure to gonorrhea or Chlamydia infection g. Complications of solid organ transplant: graft failure, rejection, cardiac allograft vasculopathy h. Gestational trophoblastic disease with decreasing or undetectable B-hCG levels i. Mirena only: i. History of breast cancer with no evidence of current disease for 5 years ii. Acute liver disease or liver tumor iii. Positive or unknown antiphospholipid antibodies j. ParaGard only: i. Severe thrombocytopenia 3. Indicated = advantages generally outweigh theoretical or proven disadvantages; generally can be provided without restriction in these conditions. a. Valvular heart disease such as aortic stenosis without complications b. Uterine fibroids, very narrow cervical canal, cervical lacerations, or other anatomical abnormalities that do not distort the uterus c. Heavy or prolonged menstrual bleeding without clinical signs of anemia d. Nulliparous e. Less than age 20 f. Peripartum cardiomyopathy g. Rheumatoid arthritis on immunosuppressive therapy h. Past PID without subsequent pregnancy i. HIV infection j. Mirena only: i. Multiple risk factors for arterial cardiovascular disease ii. Current and history of ischemic heart disease iii. History of stroke iv. Systolic BP ≥ 160 mm Hg or diastolic ≥ 100 mm Hg, vascular disease v. Vascular disease vi. Deep venous thrombosis/pulmonary embolism risk vii. Acute DVT/PE viii. Migraine with or without aura ix. Cervical intraepithelial neoplasia x. Diabetes mellitus xi. Gallbladder disease k. ParaGard only: i. Severe dysmenorrhea ii. Endometriosis iii. Anemia

4. Examination: Physical exam per Title X Guidelines a. Refer to Nursing Policy Section IV-Health Care Services

5. Laboratory: Laboratory tests to include (but not limited to): a. Pap smear (if indicated according to the DH Cervical Cancer Screening Clinical Care Guideline), which rules out cervical malignancy within the normal screening interval for the client if the client does not have medical insurance. i. Cervical intraepithelial neoplasia (CIN) is listed as a condition for which the advantages of using the method generally outweigh the theoretical proven risk for Mirena. CIN is a condition for which there is no restriction for the use of the contraceptive method for ParaGard. ii. An IUD/IUS should not be initiated for a client who has cervical cancer. b. GC and Chlamydia tests within 60 days of insertion; may be done at time of insertion c. Other STD testing per DMHC standard protocols d. Urine HCG

B. Evaluation day of insertion: 1. Review the Screening Form to be sure insertion is appropriate 2. Review previously completed laboratory results (Pap smear, GC & CT, urine HCG) to be sure any positive results have been managed appropriately 3. Complete the consent form 4. Repeat urine HCG prior to the insertion 5. If the patient is symptomatic and the symptoms are suggestive of bacterial vaginosis (BV), a wet prep may be done prior to insertion. If the exam/wet prep meet criteria for BV treatment, the patient may be provided medication for BV treatment on the day of insertion

IV. Patient education/Informed Consent A. Have patient read the FDA approved patient brochure for the particular IUD/IUS that she is to have inserted B. Reinforce the effects of the IUD/IUS on the menstrual cycle C. Reinforce that this is a birth control method for women wanting a long-acting method D. Patient must sign the patient consent supplied by this office on the day of insertion 1. One copy of the consent will be kept on file in the office 2. The other copy of the consent and the patient package insert included with the IUD/IUS and notation of when it is due for removal must be given to the patient

V. Timing of Insertion 1. The IUD/IUS may be inserted any time during the menstrual cycle under the following conditions so long as pregnancy can be ruled out: a. During menses and up to day 7 of cycle. b. No unprotected intercourse since LMP. c. On a highly effective method of birth control with consistent use (oral contraceptives, Ortho Evra, Nuva Ring, Depo Provera). d. No unprotected intercourse for at least 2 weeks prior to insertion. 2. Postpartum insertion a. Breastfeeding women: insertion at six to eight weeks postpartum is preferable. (Although a few case reports and a small study suggested a higher risk of perforation among breastfeeding women, other studies found no evidence of increased risk). b. Non-breastfeeding women: may insert at greater than 4 weeks if patient has not had menses, not had intercourse since delivery, or has used a reliable method with each act of intercourse. 3. Immediately after or within three weeks of an uncomplicated first trimester abortion with a well-involuted uterus and no post-abortion sepsis. 4. Within 5 days of unprotected intercourse if she desires a post-coital contraception (ParaGard IUD only).

VI. Postcoital Insertion of IUDs A. The ParaGard IUD is effective in preventing pregnancy after unprotected intercourse and within 5 days after the earliest estimated date of ovulation.

VII. Pre-insertion Management

1. The latest U.S. trial (Walsh, et.al., 1998) suggests that the use of prophylactic antibiotics at the time of IUD/IUS insertion is not beneficial. 2. Subacute bacterial endocarditis prophylaxis prior to IUD/IUS insertions is not recommended. 3. For preinsertion pain management patients may be given a non-steroidal anti- inflammatory drug (NSAID) such as ibuprofen 400mg ii tabs p.o. 30-60 minutes prior to insertion. 4. If the patient has a stenotic os, refer to gyn for insertion of the IUD/IUS. 5. Local anesthesia at the tenaculum site: options include no anesthesia or apply 2% Lidocaine Hydrochloride Jelly at the tenaculum site, then leave a jelly-soaked cotton tipped applicator in the cervical canal for 1 minute before proceeding with the IUD/IUS insertion.

VIII. IUD/IUS Insertion Technique: 1. Document baseline pulse and blood pressure prior to insertion. 2. Document IUD/IUS type, depth to which uterus sounded, string length after insertion and trimming, and lot # of the IUD/IUS. 3. Use insertion techniques as detailed in the package insert or in “ContraceptiveTechnology”. 4. A sterile tray with the following items needs to be available: speculum, cup for aseptic solution, uterine sound, tenaculum, uterine forceps, cervical dilator, cotton balls or gauze, cotton-tipped applicator, scissors, and aseptic solution. Benzocaine should be available at provider request.

IX. Post-Insertion of the IUD/IUS-Vaso-vagal observation 1. All patients having an IUD/IUS inserted should be observed for vaso-vagal reactions. These are more likely if the patient experiences strong cramping or pain. 2. If the patient is dizzy or faint, she is to rest on a bed lying down where she can be readily observed. 3. If vaso-vagal reaction occurs, vital signs (pulse and blood pressure) must be taken and recorded on the patient’s chart every 5-15 minutes at least 4 times or until stable. 4. No patient should be allowed to leave the clinic feeling faint or dizzy. 5. For persistent vaso-vagal symptoms, the patient should be evaluated for perforation, abdominal bleeding, and the IUD/IUS could be removed. X. Managing IUD/IUS Complications

A. Acute complications:

1. Perforation of the Uterus: a. This occurs in approximately 1:1000 insertions. If the uterus is sounded to 10 cm or greater, consider possible perforation. b. Perforation by a sound usually occurs at midline posterior uterine wall when the uterus is markedly flexed. c. Remove the uterine sound or IUD/IUS. d. Explain the situation to the patient and reassure her. e. Have the patient remain in the clinic until stable. (Check the patient’s blood pressure and pulse every ten minutes at least 4 times or until stable). f. Document discussion of signs and symptoms of intraperitoneal bleeding. g. Provide the patient with emergency contact information (i.e. hospital emergency number). h. Inform the patient to return to the clinic if signs and/or symptoms of intraperitoneal bleeding occur. i. Consider antibiotic prophylaxis: i. Doxycycline 100mg twice a day by mouth for five days; or Amoxicillin/clavulanic acid 875 mg twice a day by mouth for five days. j. Re-examine the patient in 7 days.

2. Cramping or Pain a. Varying degrees of discomfort may be felt at the time of insertion and may be followed by cramping pain over the next 10-15 minutes. b. Pain with sounding of the uterus during insertion. i. Go slowly, consider smaller sound. ii. If severe, check alignment of uterine cavity on bimanual exam, and consider using a paracervical block before proceeding. c. Cramping or pain immediately post-insertion, for a few days after, or with each menses. i. If severe: rule out perforation, pregnancy or infection. Check blood pressure and pulse. Consider removing the IUD/IUS if indicated. ii. If mild: prescribe a mild analgesic such as ibuprofen 600mg p.o. every 6 hours prn.

3. Severe post-insertion reaction, such as syncope: a. If placement is questionable, remove IUD/IUS. An IUD/IUS can be reinserted now or at a later date. b. If the IUD/IUS is properly placed, and pulse < 60 beats per minute, consult attending physician. c. Remove the IUD/IUS if necessary.

4. Pain at the time of insertion persists, with signs of abdominal tenderness: a. If the string is present, treat as pelvic infection. b. If the string is absent, consider possibility of perforation, migration, expulsion, or pregnancy and refer to physician. B. Later complications:

1. Pregnancy with IUD in situ-A woman with an IUD in place must be evaluated promptly to confirm an intrauterine pregnancy and to exclude ectopic pregnancy. a. Do highly sensitive pregnancy test. b. Do pelvic exam, if indicated. c. If the string of the IUD/IUS is present, the IUD/IUS must be removed at the time pregnancy is discovered, regardless of whether the woman plans to continue or terminate the pregnancy. The risk of miscarriage and complications is higher if the IUD/IUS is in place. i. Counsel the client that an ectopic pregnancy, SAB, or sepsis is a possibility and review signs and symptoms of each. ii. Refer the client for health care services-(Consider Women’s Care Clinic). d. If the woman refuses to have the IUD/IUS removed at the time the pregnancy is diagnosed, she must sign a release that she has been warned of the risk of septic abortion and death during the second trimester of the pregnancy. e. If the IUD/IUS string is not present or if the IUD/IUS cannot be removed, review the risks and warning signs of miscarriage, ectopic pregnancy and infection, including where to seek emergency care. If the patient desires continuation of the pregnancy, an ultrasound must be done to determine if IUD/IUS is in the uterus, and to rule out ectopic pregnancy. Refer for evaluation by OB/GYN. f. The patient must be educated and warned to report pain, bleeding, or leakage of fluid. If there are signs of an intra-uterine infection, the patient should be immediately referred to GYN service. g. In the event of spontaneous abortion, refer to GYN service immediately for uterine evacuation and antibiotic therapy. h. Ectopic pregnancy: Because the IUD/IUS does not prevent ectopic pregnancy as effectively as intrauterine pregnancy, any woman with an IUD/IUS and a pregnancy should be evaluated to rule out an ectopic pregnancy. i. Should a pregnancy occur with an IUD/IUS in place, the ratio of ectopic to intrauterine pregnancies may be increased.

2. Absent IUD/IUS Strings a. In the event of a displaced IUD/IUS, it must be determined whether the IUD/IUS is in utero or has been expelled or translocated. If the patient has missed a menses, first rule out pregnancy. b. Procedure i. A visual check should be made for the string. ii. Gently explore the cervix with a sterile swab, sterile packing forceps, or cytobrush to try to tease out the string. iii. Explore the uterine cavity with an alligator forceps, sterile uterine sound or bow hook. Rule out pregnancy prior to exploring the uterine cavity. iv. If strings are located and brought into place, or the IUD/IUS is felt and it seems to be in place, it may be left in. However, if there is any question of abnormal placement, remove IUD/IUS, treat with antibiotics, and reinsert another IUD/IUS. v. If strings are not found, patient may elect to use an alternative method for a month and return for re-exam, or obtain an ultrasound to determine if the IUD/IUS is in the uterus. I) If the IUD/IUS is intrauterine on ultrasound, nothing needs to be done. (Patient needs to be referred to OB/GYN when desires removal). II) If the IUD/IUS is not located by ultrasound, an abdominal x-ray should be done to determine if the IUD/IUS is extrauterine. If the IUD/IUS is intraperitoneal, refer to GYN for removal.

3. Pelvic Inflammatory Disease (PID) a. Treat for PID as outlined in the STD protocol. b. There is no evidence supporting the requirement that the IUD/IUS should be removed with acute PID. c. If the IUD/IUS is not removed, close clinical follow-up is mandatory. i. Note that the Mirena package insert recommends removal after initiation of antibiotics. In making this decision, the local agency must consider the possibility that the patient may not return for removal of the IUD/IUS after microbial therapy begins. d. Inform the patient to seek care immediately if her symptoms worsen, as outlined in the STD protocol. e. If the IUD/IUS is removed, contraceptive counseling is necessary. f. If the patient is mid-cycle, and has recently had intercourse, inform her of the risk of removing the IUD/IUS and a possible subsequent pregnancy. Offer emergency contraception. If the patient decides she does not want removal, documentation must exist of discussion of need for close clinical follow-up. g. If IUD/IUS is removed, be certain the patient leaves the clinic with an alternative method of birth control.

4. Actinomyces on Pap smear-Symptomatic of PID a. Patient must receive/be referred for intensive antibiotic therapy, along with removal of the IUD/IUS, as this bacterium prefers to grow on foreign bodies. Physician consultation is required. Hospitalization is possible if symptoms are severe. b. Patients must be counseled on a different method of contraception. Subsequent reinsertion of IUD/IUS is strongly discouraged.

5. Actinomyces on Pap smear-Asymptomatic of PID a. Review the result with the cytologist/pathologist to confirm the diagnosis. b. The IUD/IUS does not have to be removed, but the patient should be informed and questioned about any symptoms suggestive of PID. If she is asymptomatic, nothing more is required. c. Treatment of asymptomatic actinomyces on Pap smear with antibiotics is not required as the actinomyces is a normal vaginal organism. Detecting actinomyces on the Pap test represents colonization rather than infection in a client without pelvic tenderness. If antibiotics are used after counseling the client regarding the very unlikely progression to salpingitis (less than 1 in 1000), treat with Ampicillin 250 mg orally qid x 14 days or doxycycline 100 mg orally bid x 14 days. Review the signs and symptoms of PID with the patient. d. Since the importance of clearing the actinomyces colonization in the asymptomatic patient is not established, there is no basis for recommending a repeat Pap to check for clearing of actinomyces.

6. Spotting and Bleeding a. Rule out pregnancy, infection or partial expulsion, and manage appropriately. b. If patient complains of excess bleeding within the first three months after insertion: i. Reassure that it is likely to get better in subsequent cycles. ii. Check hct or hgb and give ferrous supplement, if indicated. iii. Ibuprofen 600mg qid for first three days of cycle. iv. Rule out other pathology related to vaginal bleeding.

7. Partial expulsion of IUD/IUS: a. Without signs of infection, remove IUD/IUS and another IUD/IUS may be inserted. b. With PID or question of PID, treat with antibiotics and remove the partially expelled IUD/IUS. Provide alternative contraception. Another IUD/IUS may be inserted after 3 cycles.

XI. Post-Insertion IUD/IUS Education

A. Patients should be instructed to continue their current contraception until their next menses due to increased risk of expulsion in the first month. B. Patients should be instructed regarding IUD/IUS warning signs and how to contact the clinic for follow-up emergency care should problems occur. C. The patient must be instructed to call if any of the following occur: 1. Foul smelling vaginal discharge; exposure to STIs 2. Not feeling well—fever or chills 3. Pelvic or lower abdominal pain 4. Late or missed period; abnormal spotting or bleeding (ParaGard only); signs or symptoms of pregnancy 5. Unusual cramping 6. Pain with intercourse 7. Inability to locate IUD/IUS string; change in string length 8. Known expulsion D. Instruct the patient to check for the string before intercourse, during her first menstrual cycle, and then after each menses. E. Inform the patient if she wishes to discontinue the use of her IUD/IUS, she needs to make an appointment with her provider to have it removed. If she does not wish to become pregnant, she must start a new method on or before the day she has her IUD/IUS removed. F. The IUD/IUS may be removed at any time in the menstrual cycle.

XII. Follow-Up

A. The IUD/IUS user should be seen in approximately 4 weeks (after the next period). B. The six- to 12-week post-IUD/IUS examination is to include: 1. A hematocrit/Hemoglobin if indicated 2. A complete pelvic examination performed and documented 3. Documentation of visualization of the IUD/IUS string and its length 4. Review of IUD/IUS danger signs 5. Reinforce the importance of a physical exam and Pap smear as per screening guidelines C. Any patient having abnormal bleeding, without uterine tenderness, following an IUD/IUS removal should be evaluated for possible endometritis.

XIII. IUD/IUS Removal

A. Subjective Data 1. LMP and previous menstrual period 2. Medical history update 3. History of recent intercourse, if patient not menstruating 4. Reason for IUD/IUS removal

B. Objective Data 1. Physical exam/pelvic exam as indicated 2. Laboratory as indicated

C. Assessment and Plan 1. Patient requesting reinsertion of IUD/IUS. Reinsertion may be done at the same visit, at the discretion of the provider. 2. Patient requesting change in contraceptive method. a. Counsel regarding other methods of birth control. Hormonal methods may be initiated before the IUD/IUS is removed. b. Remove IUD/IUS (if patient not menstruating, counsel on risks of pregnancy). c. Provide interim method of birth control, as indicated. d. If pregnancy is desired, preconception counseling, including the benefits of folic acid, should be done. 3. Patient symptomatic of PID-refer to previous section on symptomatic PID.

XIV. Replacement of IUD/IUS: A. FDA and manufacturer recommendations must be followed in regard to replacement requirements for medicated IUS. B. Patient presenting with an old IUD/IUS may have it removed and a new one inserted. The ParaGard is effective for 10 years, Mirena for 5 years, and Skyla for 3 years. C. Patients requesting IUD/IUS reinsertion should have STD testing per the guidelines above (section III.A.5).

XV.Tracking A. Clinicians should keep a log of IUD/IUS patients. The log should include the following information: patient name, DH medical record number, date of insertion, and patient phone number. References:

Colorado Department of Public Health & Environment Women’s Health Unit. (August 2011). Title X Family Planning Program Nursing Policies.

Hatcher R A, Trussell J, Nelson AL, Cates W, & Polocar, M. (2011). Contraceptive Technology (20th Ed.). New York: Ardent Media, Inc.

U.S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR, 2010 (RR04): 1-85.