Methods | Single centre RCT. Study duration: 09/2003 to 09/2006. Follow-up: 1 year. |
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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. |
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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 |
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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