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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Jul 11;7:CD007102. doi: 10.1002/14651858.CD007102.pub3
Methods Single centre RCT.
Study duration: 09/2003 to 09/2006.
Follow-up: 1 year.
Participants Low-risk GTN.
Number eligible:131.
Number evaluable:131.
Participants randomised into two groups: group 1 = 81 and group 2 = 50 (randomisation ratio of 1.5 MTX:1 DACT applied). Reasons given for this were economic limitations
Excluded patients with choriocarcinoma.
Interventions
Outcomes
Notes Risk scoring: FIGO 2000.
Six women ( 4 in group 1 and 2 in group 2) did not complete their first-line chemotherapy, but were considered in the ITT analysis
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not described.
Allocation concealment (selection bias) Unclear risk Allocation concealment not described.
Blinding (performance bias and detection bias)
All outcomes
Unclear risk Blinding not described.
Incomplete outcome data (attrition bias)
All outcomes
Low risk 100% of randomised participants were analysed.
Selective reporting (reporting bias) Low risk All pre-specified and expected outcomes were reported. Analysis was by ITT
Other bias Unclear risk See ‘Risk of bias’ comment for Gilani 2005.

Abbreviations: CR = Complete response; CT = chemotherapy; DACT = Dactinomycin or Actinomycin D; FIGO = International Federation of Gynecology and Obstetrics; GOG = Gynecologic Oncology Group; GTN = Gestational trophoblastic neoplasia; hCG = human chorionic gonadotrophin; IM = intramuscular; ITT = Intention-to-treat; IV = intravenous; MTX = Methotrexate; MTX-FA = methotrexate-folinic acid; RCT = randomised controlled trial