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Are we managing ectopic pregnancy appropiately ?. Professor Cindy Farquhar Fertility Plus National Women’s Hospital University of Auckland. Outline. Two cases from past 12 months Evidence from RCTs for medical management of ectopic pregnancies
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Are we managing ectopic pregnancy appropiately? Professor Cindy Farquhar Fertility Plus National Women’s Hospital University of Auckland
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
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
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
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
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
Patient no 2: β-hCG results Day 27 has repeat ultrasound – R sided mass 5x9x4cm and free fluid Laparoscopic R salpingectomy
What is the evidence for expectant management of ectopic pregnancy • Cochrane Review (Hajenius 2009) • Expectant management - 1 RCT only - 75% success rate
What is the evidence for medical management of ectopic pregnancy • Cochrane review (Hajenius 2009) • Variable doses of MTX versus laparosopic surgery
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)
Entry Criteria • Unruptured ectopic pregnancy • hCG < 5000 IU/l • Adnexal mass ≤3.5 cm diameter • No fetal heart in adnexae • Normal FBC, LFT, RFT
Trial Results • Laparoscopy: 26 (93%) treated successfully • Methotrexate: 22 (88%) treated successfully (more than one injection) (no statistical difference)
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)
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
An audit of ectopic pregnancies at NWH: 6 years • 1996-2001 • 673 women with discharge diagnosis of ectopic pregnancy • Mean age 31 years
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
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
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)