| Title: |
Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial |
| Authors: |
Chappell, LC; Bell, JL; Smith, A; Linsell, L; Juszczak, E; Dixon, PH; Chambers, J; Hunter, R; Dorling, J; Williamson, C; Thornton, JG; PITCHES study group |
| Source: |
Lancet , 394 (10201) pp. 849-860. (2019) |
| Publication Year: |
2019 |
| Collection: |
University College London: UCL Discovery |
| Description: |
Background Intrahepatic cholestasis of pregnancy, characterised by maternal pruritus and increased serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth, and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment without an adequate evidence base. We aimed to evaluate whether ursodeoxycholic acid reduces adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. Methods We did a double-blind, multicentre, randomised placebo-controlled trial at 33 hospital maternity units in England and Wales. We recruited women with intrahepatic cholestasis of pregnancy, who were aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. Participants were randomly assigned 1:1 to ursodeoxycholic acid or placebo, given as two oral tablets a day at an equivalent dose of 500 mg twice a day. The dose could be increased or decreased at the clinician's discretion, to a maximum of four tablets and a minimum of one tablet a day. We recommended that treatment should be continued from enrolment until the infant's birth. The primary outcome was a composite of perinatal death (in-utero fetal death after randomisation or known neonatal death up to 7 days after birth), preterm delivery ( |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10080103/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10080103/1/1-s2.0-S014067361931270X-main.pdf; https://discovery.ucl.ac.uk/id/eprint/10080103/ |
| Rights: |
open |
| Accession Number: |
edsbas.F666C7E7 |
| Database: |
BASE |