Pitch: Two randomised controlled trials in obstetric cholestasis: ursodeoxycholic acid versus placebo and early delivery versus expectant management. (7th June 2011)

• Record Type: Journal Article
• Authors: Chappell, L C; Gurung, V; Chambers, J; Seed, P T; Williamson, C; Thornton, J G
• Is Part Of: Archives of disease in childhood. Volume 96(2011)Supplement 1
• Page Start: Fa110
• Page End: Fa111
• Publication Date: 2011-06-07
• Subjects: Infants -- Diseases -- Periodicals; Newborn infants -- Diseases -- Periodicals; Fetus -- Diseases -- Periodicals; 618.920105
• DOI: 10.1136/adc.2011.300163.47
• Languages: English
• ISSNs: 1359-2998

Abstract

Abstract : 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.