Methotrexate Administration for Ectopic Pregnancy

1. Methotrexate Administration for Ectopic Pregnancy A Process Improvement and Guideline Update Jamila Mallory RN BSN University of Colorado Health Women's Services June 13, 2013

2. Ectopic Pregnancy Any pregnancy implanted outside the uterine cavity. Approximately 97% of ectopic pregnancies are located in a fallopian tube. Ectopic pregnancies account for about 2% of all pregnancies. The leading cause of pregnancy-related, first trimester deaths among women in America. -Teal and Mukul 2007

3. Possible Ectopic Pregnancy locations

4. Why is Ectopic Pregnancy dangerous? Ruptured mass can cause hemorrhage which can lead to death.

5. Ectopic Pregnancy Risk Factors Conditions that cause changes to the normal mechanism of the fallopian tubal transport. Infection Tubal surgery Congenital anomalies Tumors Previous Ectopic Current IUD Pelvic Inflammatory Disease -Teal and Mukul 2007

6. How an Ectopic Pregnancy is Diagnosed Patient presents with 1st trimester pregnancy complaining of vaginal bleeding and/or abdominal pain.1

7. How an Ectopic Pregnancy is Diagnosed History and physical are obtained, followed by a transvaginal ultrasound (TVUS) and a serum human chorionic gonodatrophin(hCG) level. TVUS identifies intrauterine pregnancy (IUP) at 5.5 weeks gestational age with nearly 100% accuracy. hCGis useful when last menstrual period is uncertain. The discriminatory zone is used and is the level the hCGshould be for a IUP to be visualized on TVUS. That level is 1500-2500 mIU/mL. -Teal and Mukul 2007

8. Treatment Options Surgical management If patient is unstable, signs of active bleeding or hemoperitoneum, immediate surgical intervention by laparoscopic salpingectomy or salpingostomyis needed. Surgery is indicated for heterotopic pregnancy, tubal rupture, imminent risk of rupture, inability to or no desire to comply with medical treatment, contraindication to methotrexate, or failure of medical treatment. Surgery should also be considered for increased risk of failure of medical therapy such as tubal pregnancy > 5 cm or fetal cardiac activity on TVUS. -Teal and Mukul

9. Treatment Options Medical management For hemodynamically stable patients with an unruptured mass, medical management with methotrexate is appropriate. Expectant management In a clinically stable patient with an hCG < 175 mIU/mL, indeterminate TVUS and declining hCG levels; this option could be reasonable. However, due to the low complication rate of methotrexate, it is preferred to use medical vs. expectant management. -Teal and Mukul

10. What is Methotrexate? Methotrexate is an antimetabolite that inhibits the DNA synthesis, repair, and cell replication. It affects actively proliferating tissues such as bone marrow, buccal and intestinal mucosa, respiratory epithelium, malignant cells, and trophoblastic tissue. 1

11. What is Methotrexate? Since methotrexate is cytotoxic, it is considered a “high alert” medication when administered for non-oncologic diagnoses. It is on University of Colorado Hospital's High Alert Medications list. This is a list of medications that require additional safety practices.

12. What is Methotrexate? The additional safety practices are: • All doses are double checked by 2 pharmacists • Alerts placed in EPIC regarding appropriate dosing

13. Treating with Methotrexate The overall success rate of treating ectopic pregnancy with methotrexate ranges from 71.2% to 94.2% in observational studies. Success depends on the regimen used, gestational age, and the hCG level.1

14. Treating with Methotrexate Indications Hemodynamically stable patient Desires future fertility Able to return for follow up care General anesthesia poses a risk No contraindications to methotrexate Unruptured mass < 3.5 cm *No fetal cardiac activity *hCG level preferably < 15,000 Contraindications Breastfeeding Immunodeficiency Renal, Liver, or Pulmonary disease Abnormal creatinine and AST Peptic Ulcer Disease Blood disorders Known sensitivity to methotrexate *Gestastional sac > 3.5 cm *Cardiac activity -Teal and Mukul

15. Treating with Methotrexate There are 3 treatment protocols per ACOG guideline (June 2008) 1. Single dose regimen 2. Two dose regimen 3. Fixed multi-dose regimen CBC, Comprehensive panel, Type and screen and hCG are obtained and reviewed prior to administration.

16. ACOG Practice Bulletin 2008

17. ACOG Practice Bulletin 2008

18. ACOG Practice Bulletin 2008

19. Treating with Methotrexate Single dose regimen is the simplest and as effective as the other regimens.1 It is the regimen most often used at University of Colorado Hospital.

20. Treating with Methotrexate Side effects Nausea/vomitingVaginal bleeding Increased abdominal pain Gastric upset Dizziness Pneumonitis Increase in hCG level from day1 to day 4 -Teal and Mukul

21. Treating with Methotrexate Signs of treatment failure: • Increasing or plateauing hCG levels • Signs of hemodynamic instability • Significant worsening abdominal pain • Less than 15% decline in hCG level between day 4 and day 7

22. Nurses Role • Patient education per Methotrexate for Ectopic Pregnancy handout • Confirm labs have been reviewed • Confirm consent has been signed • Ensure current height and weight were obtained • Assist with arranging follow up • Administer medication per guideline • Provide support for patient in her loss

23. Guideline Updates • Methotrexate may now be administered in the OB/GYN clinic • Cancer Center Pharmacy will tube medication to clinic, double bagged in a secured tube. • For Extended Hours Clinic the Inpatient Pharmacy will prepare and tube medication • Pharmacy will notify RN when medication is being tubed and give security code to obtain secured tube at Faculty tube station • Chemo protective equipment are now stored in the Clean Utility • A yellow chemo waste bin is now stored in the Dirty Utility for disposal of supplies

24. References 1. American Congress of Obstetricians and Gynecologists. Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists. (2008) 2. Mukul, L. & Teal, S. (2007). Current Management of Ectopic Pregnancy. Obstetrics and Gynecology Clinics of North America, 34 (2007), 403-419. Retrieved from University of Colorado Health Sciences online library.