Table 1.
Maternal personal and biochemical characteristics at randomisation. Values are numbers (percentages) unless stated otherwise
Characteristics | Ursodeoxycholic acid group (n=56) | Placebo group (n=55) | Early term delivery group (n=30) | Expectant management group (n=32) |
---|---|---|---|---|
Mean (SD) gestational age (weeks) | 34.0 (3.1) | 34.4 (2.9) | 35.3 (2.6) | 35.3 (1.8) |
Mean (SD) age (years) | 30.2 (6.0) | 29.5 (5.3) | 28.8 (6.2) | 29.2 (5.5) |
Ethnic group: | ||||
White | 41 (73) | 45 (82) | 25 (83) | 25 (78) |
Black | 5 (9) | 3 (5) | 2 (7) | 4 (13) |
Asian | 7 (13) | 6 (11) | 2 (7) | 3 (9) |
Other | 3 (5) | 1 (2) | 1 (3) | 0 (0) |
Previous pregnancies ≥24 weeks: | ||||
0 | 23 (41) | 25 (45) | 12 (40) | 14 (44) |
1 | 17 (30) | 19 (35) | 12 (40) | 9 (28) |
≥2 | 16 (29) | 11 (20) | 6 (20) | 9 (28) |
Previous pregnancies <24 weeks: | ||||
0 | 36 (64) | 31 (56) | 16 (53) | 24 (75) |
1 | 10 (18) | 18 (33) | 9 (30) | 6 (19) |
≥2 | 10 (18) | 6 (11) | 5 (17) | 2 (5) |
History of intrahepatic cholestasis of pregnancy | 18/33 (55) | 14/30 (47) | 10/18 (56) | 9/18 (50) |
History of liver disease | 2 (4) | 2 (4) | 2 (7) | 1 (3) |
Twin pregnancy | 4 (7) | 9 (16) | 0 (0) | 1 (3) |
Biochemistry at enrolment: | ||||
Median (IQR) bile acid (µmol/L) | 26.9 (18.0-39.5) | 25.0 (17.0-40.6) | 24.0 (15.0-36.0) | 24.0 (17.5-37.8) |
Median (IQR) ALT (U/L) | 113.0 (55.0-183.0) | 75.0 (36.0-125.0) | 107.0 (50.0-159.0) | 102.5 (36.0-174.0) |
Median (IQR) AST (U/L) | 70.0 (49.0-130.0) | 49.5 (33.5-83.5) | 62.0 (49.0-74.0) | 47.5 (18.0-140.0) |
Median (IQR) GGT (U/L) | 24.0 (18.0-32.0) | 26.0 (15.0-36.0) | 23.5 (15.0-31.0) | 25.0 (18.0-32.0) |
Median (IQR) bilirubin (µmol/L)) | 9.0 (7.0-12.0) | 9.0 (6.0-11.0) | 9.5 (7.0-13.0) | 9.0 (7.0-13.0) |
Severity of disease (bile acid levels): | ||||
Severe* | 14 (25) | 14 (25) | 6 (20) | 7 (22) |
Mild† | 35 (63) | 36 (66) | 18 (60) | 20 (62) |
Raised ALT levels only‡ | 7 (12) | 5 (9) | 6 (20) | 5 (16) |
Maternal itching score (mm on VAS): | ||||
Mean (SD) worst episode of itch over past 24 hours | 70.9 (20.7) | 59.7 (22.3) | 61.8 (25.0) | 58.1 (27.4) |
Mean (SD) average itch over past 24 hours | 47.4 (22.3) | 47.1 (26.0) | 43.7 (27.6) | 43.6 (22.8) |
IQR=interquartile range; ALT=alanine transaminase; AST=aspartate transaminase; GGT=γ-transferase; VAS=visual analogue scale.
*Bile acid levels >40 µmol/L.
†Bile acid levels greater than upper limit of normal ≤40 µmol/L.
‡Normal bile acid levels with raised alanine transaminase levels (>100 U/L).