Abstract
BackgroundPatients 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.Methods/DesignA multicentre randomised controlled trial in The Netherlands. Hemodynamically stable patients with an EP visible on transvaginal ultrasound and a plateauing serum hCG concentration < 1,500 IU/L or with a persisting PUL with plateauing serum hCG concentrations < 2,000 IU/L are eligible for the trial. Patients with a viable EP, signs of tubal rupture/abdominal bleeding, or a contra-indication for MTX will not be included. Expectant management is compared with systemic MTX in a single dose intramuscular regimen (1 mg/kg) in an outpatient setting. Serum hCG levels are monitored weekly; in case of inadequately declining, systemic MTX is installed or continued. In case of hemodynamic instability and/or signs of tubal rupture, surgery is performed. The primary outcome measure is an uneventful decline of serum hCG to an undetectable level by the initial intervention. Secondary outcomes are (re)interventions (additional systemic MTX injections and/or surgery), treatment complications, health related quality of life, financial costs, and future fertility. Analysis is performed according to the intention to treat principle. Quality of life is assessed by questionnaires before and at three time points after randomisation. Costs are expressed as direct costs with data on costs and used resources in the participating centres. Fertility is assessed by questionnaires after 6, 12, 18 and 24 months. Patients' preferences will be assessed using a discrete choice experiment.DiscussionThis trial will provide guidance on the present management dilemmas in women with EPs and PULs with low and plateauing serum hCG concentrations.Trial registrationCurrent Controlled Trials ISRCTN 48210491
Highlights
Patients with ectopic pregnancy (EP) and low serum human chorionic gonadotrophin (hCG) concentrations and women with a pregnancy of unknown location (PUL) and plateauing serum hCG levels are commonly treated with systemic methotrexate (MTX)
EP is usually diagnosed by non-invasive methods, i.e. by sensitive pregnancy tests in urine and serum, and high resolution transvaginal sonography (TVS), which have been integrated in reliable diagnostic algorithms
Data provided by randomised controlled trials (RCTs) indicate that systemic MTX treatment should only be used in selected patients with EP
Summary
In industrialized countries the incidence of ectopic pregnancy (EP) is approximately 1 to 2% of all pregnancies [14]. EP is usually diagnosed by non-invasive methods, i.e. by sensitive pregnancy tests in urine and serum, and high resolution transvaginal sonography (TVS), which have been integrated in reliable diagnostic algorithms. These algorithms, in combination with increased awareness and knowledge of risk factors among both clinicians and patients, have enabled an early and accurate diagnosis of EP [5,6,7]. Expectant management has not been properly evaluated in RCTs in selected patients with EP [12] In these non-surgical treatments, the pregnancy is not removed and as a consequence there is a remaining risk of tubal rupture. This study compares both treatment options in these particular subgroups of women, representing about 10% of women with suspected EP
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