Table 2.
Perinatal outcomes
| Ursodeoxycholic acid (n=322) | Placebo (n=318) | Adjusted effect estimate (95% CI) | p value | ||
|---|---|---|---|---|---|
| Perinatal death, preterm delivery,* or neonatal unit admission | 74 (23%) | 85 (27%) | RR 0·85 (0·62 to 1·15) | 0·28 | |
| In-utero fetal death | 1 (<1%) | 2 (1%) | RR 0·51 (0·04 to 6·25) | 0·60 | |
| Preterm delivery* | 54 (17%) | 65 (20%) | RR 0·79 (0·57 to 1·10) | 0·17 | |
| Known neonatal death up to 7 days after birth | 0 | 0 | .. | .. | |
| Neonatal unit admission for ≥4 h | 45 (14%) | 54 (17%) | RR 0·81 (0·58 to 1·13) | 0·21 | |
| Livebirth | 321 (>99%) | 316 (99%) | .. | .. | |
| Gestational age at delivery, weeks | 37·6 (37·1–38·1) | 37·4 (37·0–38·1) | Median difference 0·1 (0·0 to 0·3) | 0·065 | |
| Birthweight, g | 3105 (2775–3390) | 3040 (2660–3320) | Median difference 94·0 (18·7 to 169·3) | 0·014 | |
| Birthweight percentile† | 59·3 (28·4) | 56·3 (27·8) | .. | .. | |
| <10th percentile | 16 (5%) | 18 (6%) | RR 0·89 (0·47 to 1·69) | 0·73 | |
| <3rd percentile | 7 (2%) | 7 (2%) | RR 1·09 (0·38 to 3·12) | 0·88 | |
| Mode of delivery | |||||
| Spontaneous vaginal (cephalic) | 193 (60%) | 182 (57%) | RR 1·04 (0·91 to 1·20) | 0·56 | |
| Vaginal (breech) | 1 (<1%) | 3 (1%) | .. | .. | |
| Assisted vaginal (cephalic) | 21 (7%) | 35 (11%) | .. | .. | |
| Pre-labour caesarean | 71 (22%) | 62 (19%) | .. | .. | |
| Caesarean | 36 (11%) | 36 (11%) | RR 1·00 (0·68 to 1·46) | 1·0 | |
| Presence of meconium-stained amniotic fluid | 34 (11%) | 52 (16%) | RR 0·65 (0·43 to 0·98) | 0·040 | |
| Apgar score at 5 min after birth‡ | 9·0 (9·0–10·0) | 9·0 (9·0–10·0) | Median difference 0 (−0·4 to 0·4) | 1·0 | |
| Apgar score of <7 at 5 min after birth‡, n/N (%) | 8/321 (2%) | 7/316 (2%) | .. | .. | |
| Umbilical cord blood sampling, N | 112 | 102 | .. | .. | |
| Umbilical arterial pH | 7·2 (0·1) | 7·2 (0·1) | Mean difference −0·02 (−0·04 to 0·01) | 0·18 | |
| Nights in the neonatal unit§ | 5·5 (3·0–13·0) | 6·0 (2·0–16·0) | Median difference 0 (−3·2 to 3·2) | 1·0 | |
| Main diagnosis for first neonatal unit admission | |||||
| Prematurity, n/N (%) | 14/45 (31%) | 17/54 (31%) | .. | .. | |
| Respiratory disease, n/N (%) | 16/45 (36%) | 15/54 (28%) | .. | .. | |
| Infection suspected or confirmed, n/N (%) | 5/45 (11%) | 7/54 (13%) | .. | .. | |
| Other¶, n/N (%) | 10/45 (22%) | 15/54 (28%) | .. | .. | |
Data are n (%), median (IQR), or mean (SD), unless otherwise indicated; N is equal to the total number of infants in the group, unless otherwise indicated; <1% of observations are missing, unless otherwise indicated. Adjusted effect estimates and p values are shown for primary outcomes, and for secondary outcomes that were prespecified for testing in the published protocol.11 RR=risk ratio.
*
Delivery at <37 weeks' gestation.
†
Calculated using the INTERGROWTH-21st tool.19
‡
Data are for livebirths only.
§
Data are for infants with at least one night in a neonatal unit only.
¶
A full list of diagnoses is given in the appendix (p 29).