Shobeiri 2014.
| Methods | Randomised single‐blind trial conducted in Iran with recruitment between 2011 and 2013. Clinical trial registration ID: IRCT201105236563N1 | |
| Participants | Women with untreated low‐risk GTN (LRGTN) stage I and (WHO) prognostic scoring of 6 or less. Inclusion criteria: women with a plateau or increase in serum BhCG level or persistent elevation above the normal B‐hCG value 16 weeks after molar (complete or incomplete) evacuation . Plateau BhCG level is defined as 10% or less change in BhCG titre at least over 3 weeks (4 values in days 1, 7, 14, 21) and rising BhCG titre is defined as greater than 10% increase in BhCG titre at least over 2 weeks (3 values in days 1, 7, 14) . Exclusion criteria: histologically‐confirmed choriocarcinoma or placental site trophoblastic tumour (PSTT), did not agree to have effective contraception for the duration of the study, metastasis, FIGO prognostic score of 7 or more, willing to continue breast feeding, presence of other malignancies with disease free duration less than 5 years, contraindication for protocols of chemotherapy due to previous cancer treatment, prior chemotherapy or hysterectomy for GTN Number eligible: 64 Number evaluable: 64 |
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| Interventions | Group 1: Act D, IV, 1.25 mg/m² repeated every 2 weeks. Group 2: MTX 1 mg/kg per day on days 1, 3, 5,and 7 IM with IM Folinic Acid 0.1 mL/kg per day on days 2, 4, 6, and 8. |
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| Outcomes | Primary: CR Secondary: adverse events |
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| Notes | Info and data extracted from published English abstract only as the published paper could not be obtained for translation. Emailed for more details on the 28/3/16 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 'randomly assigned' ‐ sequence generation not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | 'single‐blind' but no details provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Few data available in conference abstract only |
| Selective reporting (reporting bias) | Unclear risk | Published abstract gave data on response to treatment but was insufficient for other outcomes |
| Other bias | Unclear risk | Insufficient details in published abstract to make a judgement |