To study whether expectant management is an alternative to treatment with systemic MTX in a single dose im regimen in women with an EP and low but plateauing serum hCG concentrations in terms of tubal rupture, future pregnancy, health related quality of life and costs.
Norah M van Mello1*, Femke Mol1, Albert H Adriaanse2, Erik A Boss3, Antonius B Dijkman4, Johannes PR Doornbos5, Mark H Emanuel6, Jaap Friederich7, Loes Leeuw-Harmsen8, Jos P Lips9, Evert JP van Santbrink10, Harold R Verhoeve11, Harry Visser12, Willem M Ankum1, Fulco Veen13, Ben W Mol1 and Petra J Hajenius1
Patients with ectopic pregnancy (EP) and low serum hCG concentrations and women with a pregnancy of unknown location (PUL) and plateauing serum hCG levels are commonly treated with systemic methotrexate (MTX). However, there is no evidence that treatment in these particular subgroups of women is necessary as many of these early EPs may resolve spontaneously. The aim of this study is whether expectant management in women with EP or PUL and with low but plateauing serum hCG concentrations is an alternative to MTX treatment in terms of treatment success, future pregnancy, health related quality of life and costs.
Simultaneously with this trial, another trial is ongoing in the United Kingdom . This placebo controlled trial has a similar objective, uses the same inclusion criteria and interventions (single shot MTX im and expectant management). In the UK trial, however, surgical intervention is installed in both treatment groups if inadequately declining serum hCG concentrations occur after one week of follow up. In our study, these treatment failures are treated with additional MTX injections. In the near future, meta analysis of the results of both trials will provide guidance on the present management dilemmas in women with EP or PUL with low and plateauing serum hCG concentrations.