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Single dose systemic methotrexate versus expectant management for treatment of tubal ectopic pregnancy: A placebo-controlled randomised trial

Jurkovic, D; Memtsa, M; Sawyer, E; Donaldson, A; Jamil, A; Schramm, K; Sana, Y; ... Ross, JA; + view all (2017) Single dose systemic methotrexate versus expectant management for treatment of tubal ectopic pregnancy: A placebo-controlled randomised trial. Ultrasound in Obstetrics & Gynecology , 49 (2) pp. 171-176. 10.1002/uog.17329. Green open access

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Abstract

OBJECTIVE: Methotrexate is routinely used worldwide for medical treatment of clinically stable women with tubal ectopic pregnancies. This is despite the lack of robust evidence to show its superior effectiveness over expectant management. The aim of our multicentre randomised trial study was to compare the success rates of methotrexate with placebo for the conservative treatment of tubal ectopic pregnancies. METHODS: The study was multicentre; it took place in three UK early pregnancy units between January 2006 and June 2014. Inclusion criteria were clinically stable women with a conclusive ultrasound diagnosis of a tubal ectopic pregnancy presenting with low serum β-hCG <1500IU/l. Women were randomly assigned to single systemic injection of methotrexate 50mg/m(2) or placebo. The primary outcome of the study was a binary indicator for success of conservative management, defined as resolution of clinical symptoms and decline of serum β-hCG to <20IU/l or negative urine pregnancy test without the need for any additional medical intervention. An intention to treat analysis was followed. RESULTS: We recruited a total of 80 women: 42 to methotrexate and 38 to placebo. The two arms of the study were balanced in terms of age, ethnicity, obstetric histories, pregnancy characteristics and serum β-hCG and progesterone. The proportions of successes were similar: 83% with methotrexate and 76% with placebo. On univariate analysis, this difference was not statistically significant (χ2(1df) = 0.53; P = 0.23). On multivariate logistic regression, β-hCG was the only covariate which was significantly associated with outcome. The odds of failure increased by 0.15% for each unit increase in β-hCG (OR=1.0015; 95% CI 1.0002 to 1.003; P = 0.02). In 14 women presenting with serum hCG 1000-1500IU/l the success of expectant management was 33% compared to 62% in the methotrexate arm. Although this result was not statistically significant a larger sample size would give us greater power to detect a difference in this subgroup of women, In women with successful conservative management there was no significant difference in median resolution times between methotrexate and placebo arms [17.5 days (IQR 14 - 28.0) (n = 30)] vs [14 days (IQR 7 - 29.5) (n = 25)] (P = 0.73) CONCLUSION: The results of our study do not support routine use of methotrexate for the treatment of clinically stable women diagnosed with tubal ectopic pregnancies presenting with low serum hCG <1500IU/l. Further work is required to identify a subgroup of women with tubal ectopic pregnancies and hCG≥1500IU/l in whom methotrexate may offer a safe and cost-effective alternative to surgery.

Type: Article
Title: Single dose systemic methotrexate versus expectant management for treatment of tubal ectopic pregnancy: A placebo-controlled randomised trial
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/uog.17329
Publisher version: http://dx.doi.org/10.1002/uog.17329
Language: English
Additional information: Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
Keywords: Expectant, Methotrexate, Placebo, Randomised controlled trial, Treatment, Tubal ectopic pregnancy
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health > Reproductive Health
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences > Dept of Statistical Science
URI: https://discovery.ucl.ac.uk/id/eprint/1528556
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