Kashimura 1986.
Methods | RCT conducted in Japan. Participants recruited between 1963 and 1977. Stated as a prospective study with participants "selected at random" to receive prophylaxis This may not be a true RCT. | |
Participants | 420 women with molar pregnancy (low and high risk). Excluded women who were referred longer than 3 weeks after evacuation; those who had received other drugs for prophylaxis (see 'Risk of bias' table below); women who had undergone hysterectomy; and women diagnosed as having partial mole or hydropic degeneration. |
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Interventions | Arm 1: methotrexate 10 mg daily (IM or oral) for 7 days, within 3 weeks of evacuation (293 women). Arm 2: no P‐Chem (127 women). Women were followed up weekly with urine hCG measurements. |
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Outcomes | GTN diagnosed by histology or Ishizuka score (a risk rating system used in Japan); side effects and subsequent pregnancy. | |
Notes | 5‐ to 15‐year follow‐up reported. Time to invasive mole diagnosis was 56.8 days in P‐Chem group and 42.7 days in control group (SD not given; P = 0.6). No attrition occurred for primary outcomes. Only reported adverse effects in the P‐Chem group: 27.3% experienced drug‐related side effects including stomatitis (10.3%), nausea/vomiting (6.8%) and leukopenia (4.4%). Grades of toxicity were not reported but the report states that there were no severe complications or drug‐related deaths. Baseline characteristics were not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | |
Selective reporting (reporting bias) | High risk | |
Other bias | High risk |