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.