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. 2012 Jun 13;344:e3799. doi: 10.1136/bmj.e3799

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).

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