A multi-centre, double-blind, placebo-controlled, randomised trial of combination methotrexate and gefitinib versus methotrexate alone to treat tubal ectopic pregnancies (GEM3)

niversity of Edinburgh and NHS Lothian ACCORD0 个研究点目标入组 328 人开始时间: 2016年9月15日最近更新: 2023年11月20日

适应症

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30458863 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36738759/ (added 06/02/2023) 2023 Results article in https://doi.org/10.1093/humrep/dead089 Secondary analysis (added 15/05/2023)

•1. Clinical decision made for treatment of tubal EP with MTX
•2. Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent
•3. Women 18-50 years at time of randomisation
•4. Diagnosis of either:
•4.1. Definite tubal EP (extrauterine gestational sac with yolk sac and/or embryo, without cardiac activity on USS) or
•4.2. Clinical decision of probable tubal EP (extrauterine sac-like structure or inhomogeneous adnexal mass on USS with a background of sub optimally rising serum hCG concentrations (on at least 2 different days)
•5. Pre-treatment serum hCG level of 1000–5000 iu/L (within 1 calendar day of treatment)
•6. Clinically stable
•7. Haemoglobin between 100 and 165 g/L within 3 calendar days of treatment
•8. Able to comply with treatment and willing to participate in follow up

•1. Women with a Ppregnancy of unknown location (PUL)
•2. Evidence of intrauterine pregnancy
•3. Breastfeeding
•4. Hypersensitivity to gefitinib
•5. Women with mean EP mass on ultrasound greater than 3.5cm (mean dimensions)
•6. Women with evidence of intrauterine pregnancy
•7. Evidence of significant intra-abdominal bleed on ultrasound USS defined by echogenic free fluid above the uterine fundus or surrounding ovary within 1 calendar day of treatment
•8. Significant abdominal pain, guarding/rigidity
•9. Clinically significant abnormal liver/renal/haematological indices noted within 3 calendar days of treatment
•10. Galactose intolerance
•11. Significant pre-existing dermatological disease eg severe psoriasis/eczema
•12. Significant pulmonary disease eg severe/uncontrolled asthma
•13. Significant gastrointestinal medical illness eg Crohn’s disease/ulcerative colitis
•14. Participating in any other clinical trial of an investigational medicinal product
•15. Previous participation in GEM3
•16. Women of Japanese ethnicity

发起方

niversity of Edinburgh and NHS Lothian ACCORD