ISRCTN67795930
Completed
Phase 3
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 sites328 target enrollmentSeptember 15, 2016
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ectopic pregnancy
- Sponsor
- niversity of Edinburgh and NHS Lothian ACCORD
- Enrollment
- 328
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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