Kim 1986

Methods	RCT conducted in Korea. Participants recruited between 1978 and 1984
Participants	133 women with complete hydatidiform mole (both high and low risk) were randomised into 2 groups, but 62 were excluded (36 lost to follow‐up, 7 had 'insufficient length of follow‐up' and 19 had hysterectomy) and only 71 completed this trial (39 in the treatment group and 32 in the untreated group)
Interventions	Arm 1: methotrexate 1.0 mg/kg/day IM on days 1, 3, 5 and 7 and citrovorum factor rescue 0.1 mg/kg/day IM on days 2, 4, 6 and 8 (39/71 women including 18/31 low‐risk and 21/40 high‐risk women). ERPC was done on the third or fourth day of P‐Chem Arm 2: no treatment other than ERPC (32 women including 13/31 low‐risk and 19/40 high‐risk women)
Outcomes	Efficacy: incidence of GTN Adverse effects: incidence of gastrointestinal toxicity, myelotoxicity, epithelial toxicity including rash, hair loss and mouth ulcers The number of courses required to achieve remission in cases of GTN Time to GTN diagnosis Subsequent pregnancy
Notes	Baseline characteristics were similar between the groups, including the proportion of low‐ and high‐risk lesions. ERPC was done on the third or fourth day of P‐Chem. Women were followed up weekly for until hCG was normal for 3 consecutive weeks, then monthly for 6 months, then bimonthly for 6 months, then every 6 months. The mean duration of follow‐up was 19 months (SD 9.7; range 6 to 50). All women were in complete remission at study closure Pregnancy rates after molar pregnancy were similar between the 2 groups (93% vs. 94%) P‐Chem had little effect on the rate of subsequent GTN in the low‐risk group; only 2/31 low‐risk women developed GTN (1 women in each study group)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	High risk	Of 133 women treated, 62 were excluded from the study (36 were lost to follow‐up, 7 had insufficient length of follow‐up and 19 had a hysterectomy). Therefore the outcome data were extracted from the 71 women (39 in the treatment group and 32 in the untreated group)
Selective reporting (reporting bias)	High risk	All the pre‐specified outcomes were reported. However, certain women were excluded from the analyses (those who underwent hysterectomy and those with insufficient follow‐up) therefore the analyses were not by intention‐to‐treat
Other bias	High risk	It is unclear on what basis the participants were initially diagnosed as having CM. If prophylaxis was given based on a clinical diagnosis before ERPC, this may have resulted in women with hydropic degeneration or PM being included in the study