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Slide 1 - Are we managing ectopic pregnancy appropiately? Professor Cindy Farquhar Fertility Plus National Women’s Hospital University of Auckland
Slide 2 - Outline Two cases from past 12 months Evidence from RCTs for medical management of ectopic pregnancies What has happened at NWH over the last 15 years? Protocols
Slide 3 - NWH protocol: suitable patients for MTX therapy Diagnosis of ectopic pregnancy -HCG <5000 Adnexal mass ≤ 3.5 cm (confirmed on NWH scan) Minimal free fluid on US (confirmed on NWH scan) Haemodynamically stable Normal FBC, LFTs, creatinine UpToDate supports this -HCG threshold Similar to RCOG but -HCG <3000
Slide 4 - Patient no 1 22 years old P0G4 (2M, 1T) Seen in WAU with 1 wk spotting β-hCG = 11100 Labtest, 15600 Labplus US 38mm L ectopic pregnancy Offered MTX as one of the options Consented and had treatment same day Discharged home with follow up arranged in 4 days
Slide 5 - Patient No 1 - β-hCG results Admitted to NWG with collapse and pain and required emergency laparotomy, left salpingectomy and sustained bladder injury requiring further laparotomy 2 days later
Slide 6 - Patient No 2 – 27 years old P0G1 Presented to GP with 3 weeks of bleeding GP measured β-hCG = 130, 5 days later 92, 7 days later 90 US - no IUP Referred to EPAU on day 12
Slide 7 - Patient no 2: β-hCG results Day 27 has repeat ultrasound – R sided mass 5x9x4cm and free fluid Laparoscopic R salpingectomy
Slide 8 - What is the evidence for expectant management of ectopic pregnancy Cochrane Review (Hajenius 2009) Expectant management - 1 RCT only - 75% success rate
Slide 9 - What is the evidence for medical management of ectopic pregnancy Cochrane review (Hajenius 2009) Variable doses of MTX versus laparosopic surgery
Slide 10 - An RCT of laparoscopic management of ectopic pregnancy compared with methotrexate Pragmatic open randomised trial (computer generated, numbered sealed envelopes) Ultrasound diagnosis (no diagnostic laparoscopy) Recruitment from 3 hospitals (NWH, NSH, MMH)
Slide 11 - Entry Criteria Unruptured ectopic pregnancy hCG < 5000 IU/l Adnexal mass ≤3.5 cm diameter No fetal heart in adnexae Normal FBC, LFT, RFT
Slide 12 - Trial Results Laparoscopy: 26 (93%) treated successfully Methotrexate: 22 (88%) treated successfully (more than one injection) (no statistical difference)
Slide 13 - Trial Profile
Slide 14 - Tube conservation and need for further surgery 17 (61%) conserved ipsilateral tube with surgery and 31 (91%) with MTX 2 patients with persistent trophoblast in surgical group and 5 (12%) required surgery in the MTX group (3 had tubal rupture)
Slide 15 - Methotrexate was cheaper
Slide 16 - Conclusions MTX well tolerated by patients MTX cheaper than laparoscopy MTX associated with fewer salpingectomies BUT MTX only effective at relatively low hCG levels Less than 30% of ectopic pregnancies likely to be suitable for MTX Multiple doses may be needed
Slide 17 - An audit of ectopic pregnancies at NWH: 6 years 1996-2001 673 women with discharge diagnosis of ectopic pregnancy Mean age 31 years
Slide 18 - Initial management of ectopic pregnancy NWH
Slide 19 - Use of Methotrexate NWH 1996-2001
Slide 20 - Methotrexate Over the six year period: 74/673 (11%) women given MTX 14/74 (18.9%) failed & required surgery 8 % given MTX who did not met criteria (hCG > 5000 IU/L) but included cornual & cervical pregnancy
Slide 21 - Audit at NWH in 2010 66 ectopics over 6 month period 12% expectant management 33% medical management 55% surgical management Of medical management – 36% rate of failure 43% had breach of the protocol with 75% presenting as ruptured ectopics Common breaches of the protocol were relying on community scan, significant free fluid in the POD
Slide 22 - Further audits by Trainee Interns
Slide 23 - New Research ESEP study: European surgery in ectopic pregnancy: salpingotomy versus salpingectomy in tubal ectopic pregnancy: impact on future fertility (www.esepstudy.nl) METEX study; methotrexate versus expectant management in ectopic pregnancy (www.metexstudy.nl)