Results
Between 23rd December 2015 and 7th August 2018, 2737 women were screened for trial inclusion, of whom 1418 were found to be eligible. 605 women were recruited to the trial, including 37 women with a twin pregnancy, across 33 maternity units. 305 women were randomly allocated to UDCA and 300 women were randomly allocated to placebo. Follow-up to maternal and infant discharge continued until December 2018.6
Of the 605 women recruited, 79 women with no post-randomisation visit data were excluded from the secondary analysis. The majority of the excluded women (76/79, 96%) delivered within two weeks of randomisation. Two women withdrew from the trial: one withdrew consent for further data collection and no post-randomisation data was collected, and one withdrew consent to use data. Both were also excluded. Maternal baseline characteristics and maternal outcomes for the 527 women included in the secondary analysis (256 allocated to placebo, 271 allocated to UDCA) are shown in Table S1. Perinatal outcomes for the 558 infants born to these women are shown in Table S2. A flow diagram describing the participants included in each individual analysis is shown in Figure S1.