Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a
secondary analysis of the PITCHES trial
Abstract
Objective: To evaluate whether a particular group of women with
intrahepatic cholestasis of pregnancy would benefit from treatment with
ursodeoxycholic acid. Design: Secondary analysis of the PITCHES trial
(ISRCTN91918806). Setting: United Kingdom. Population or Sample: Women
with intrahepatic cholestasis of pregnancy. Methods: Subgroup analyses
were performed to determine whether baseline bile acid concentrations or
baseline itch scores moderated a woman’s response to treatment with
ursodeoxycholic acid. Main Outcome Measures: Bile acid concentration and
itch score. Results: In women with baseline bile acid concentrations
less than 40 μmol/L, treatment with UDCA resulted in increased
post-randomisation bile acid concentrations (geometric mean ratio 1.19,
95% CI 1.99 to 1.41, p = 0.048). A test of interaction showed no
significance (p = 0.647). A small, clinically insignificant difference
was seen in itch response in women with a high baseline itch score
(–6.0 mm, 95% CI –11.80 to –0.21, p = 0.042), with a test of
interaction not showing significance (p = 0.640). Further subgroup
analyses showed no significance. Across all women there was a weak
relationship between bile acid concentrations and itch severity.
Conclusions: There was no subgroup of women with intrahepatic
cholestasis of pregnancy in whom a beneficial effect of treatment with
ursodeoxycholic acid on bile acid concentration or itch score could be
identified. This confirms that its routine use in women with this
condition for improvement of bile acid concentration or itch score
should be reconsidered. Funding: NIHR Efficacy and Mechanism Evaluation
Programme 12/164/16. Keywords: Cholestasis, Pregnancy, Ursodeoxycholic
acid, Perinatal, Stillbirth.