Background There remains considerable uncertainty as to whether women with obstetric cholestasis should receive ursodeoxycholic acid to alleviate itching or improve fetal/neonatal outcomes and whether the benefits of early delivery (compared to expectant management) are outweighed by the risks.
Methods We conducted two parallel randomised controlled trials of (1) ursodeoxycholic acid (UDCA) versus placebo and (2) early delivery versus expectant management in 125 women with obstetric cholestasis, from nine consultant-led maternity units in UK. Following an on-line survey, the pre-specified clinically important difference in itching VAS was 30 mm.
Results Of 111 women in the drug comparison, women treated with UDCA had a 16mm (95% CI 6 to 27) greater reduction in itching VAS and a greater reduction in ALT (ratio of geometric means 0.59 (0.45 to 0.79) than those on placebo. Gestational age at delivery did not differ between the two groups (risk difference 0.09 (−0.54 to 0.72)).
Of 63 women in the timing of delivery comparison, 7/30 (23%) in the immediate delivery group had a caesarean section compared to 11/33 (33%) (risk ratio 0.70 (0.31 to 1.57). There was no difference in other major neonatal outcomes.
Conclusions UDCA has minimal clinical impact on maternal itching.
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Funding RfPB NIHR.