Methotrexate vs expectant management of tubal ectopic pregnancy: IPDMA
Research type
Research Study
Full title
Methotrexate versus expectant management for treatment of tubal ectopic pregnancy: an individual patient data meta-analysis and student study
IRAS ID
293525
Contact name
Davor Jurkovic
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
CRD42021214093, PROSPERO
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
Ectopic pregnancies affect 1-2% of pregnancies worldwide. Due to improvements in diagnostics over the years, ectopic pregnancies have become less life-threatening conditions and are increasingly being managed in a more conservative non-surgical approach. Asymptomatic women with low serum beta human chorionic gonadotrophin (β-hCG) are often offered medical treatment with methotrexate. Various studies have shown, however, that expectant management can be a feasible and safe alternative treatment in these women. Despite the lack of good quality data on the effectiveness of methotrexate over expectant management, it is a prevalent treatment choice.
The aim of this study is to strengthen the evidence that compares systemic methotrexate to expectant management in treating a tubal ectopic pregnancy, by combining data sets and undertaking an individual participant data meta-analysis (IPDMA), the gold standard of meta-analysis. We will perform a systematic review and include all randomized controlled trials (RCTs) that studied women with a tubal ectopic pregnancy and were randomized to receive either systemic methotrexate or expectant management. Investigators of the individual trials will be asked to share their individual participant data (IPD). This will allow us to increase statistical power by combining efforts and re-analysing data already available.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/PR/1301
Date of REC Opinion
24 Sep 2021
REC opinion
Favourable Opinion