Table 2.
Perinatal and maternal outcomes according to ursodeoxycholic acid treatment for singleton pregnancies using individual participant data from all studies
|
All studies (n=34) |
Randomised controlled trials (n=4) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Treated with ursodeoxycholic acid | Not treated with ursodeoxycholic acid | aOR (95% CI) | p value | Treated with ursodeoxycholic acid | Not treated with ursodeoxycholic acid | aOR (95% CI) | p value | |
| Perinatal outcomes | ||||||||
| Stillbirth | 21/3700 (0·6%) | 11/1801 (0·6%) | 0·71 (0·10–4·99) | p=0·73 | 1/388 (0·3%) | 2/367 (0·5%) | 0·40 (0·03–4·66) | p=0·46 |
| Composite outcome | 1262/3881 (32·5%) | 353/1955 (18·1%) | 0·68 (0·48–0·97) | p=0·034 | 42/388 (10·8%) | 67/367 (18·3%) | 0·51 (0·33–0·78) | p=0·002 |
| Total preterm birth (<37 weeks' gestation) | 1258/3855 (32·6%) | 347/1952 (17·8%) | 0·69 (0·48–0·98) | p=0·040 | 42/387 (10·9%) | 66/366 (18·0%) | 0·51 (0·33–0·79) | p=0·002 |
| Spontaneous preterm birth (<37 weeks' gestation) | 365/3702 (9·9%) | 109/1932 (5·6%) | 0·54 (0·31–0·94) | p=0·028 | 18/387 (4·7%) | 32/366 (8·7%) | 0·46 (0·25–0·86) | p=0·015 |
| Iatrogenic preterm birth (<37 weeks' gestation) | 740/3702 (20·0%) | 218/1932 (11·3%) | 0·88 (0·56–1·37) | p=0·56 | 24/387 (6·2%) | 34/366 (9·3%) | 0·63 (0·37–1·09) | p=0·10 |
| Meconium-stained amniotic fluid | 499/3360 (14·9%) | 266/1760 (15·1%) | 0·58 (0·41–0·83) | p=0·003 | 48/385 (12·5%) | 72/365 (19·7%) | 0·54 (0·36–0·81) | p=0·003 |
| Apgar score <7 at 5 min | 115/3607 (3·2%) | 32/1902 (1·7%) | 0·76 (0·31–1·88) | p=0·56 | 5/386 (1·3%) | 7/361 (1·9%) | 0·67 (0·21–2·15) | p=0·51 |
| Umbilical cord arterial pH <7·0 | 3/1351 (0·2%) | 8/779 (1·0%) | 0·37 (0·04–3·30) | p=0·37 | 1/136 (0·7%) | 3/141 (2·1%) | 0·27 (0·02–2·89) | p=0·28 |
| Large for gestational age | 462/2878 (16·1%) | 213/1217 (17·5%) | 1·55 (1·07–2·25) | p=0·021 | 65/354 (18·4%) | 44/338 (13·0%) | 1·55 (1·02–2·37) | p=0·040 |
| Small for gestational age | 121/2878 (4·2%) | 39/1217 (3·2%) | 1·33 (0·61–2·93) | p=0·48 | 11/354 (3·1%) | 8/338 (2·4%) | 1·30 (0·51–3·28) | p=0·58 |
| Neonatal unit admission | 729/3407 (21·4%) | 371/1842 (20·1%) | 0·72 (0·50–1·06) | p=0·097 | 34/387 (8·8%) | 48/366 (13·1%) | 0·64 (0·40–1·02) | p=0·061 |
| Perinatal death | 19/2747 (0·7%) | 9/1439 (0·6%) | 0·54 (0·06–4·83) | p=0·58 | 1/335 (0·3%) | 2/320 (0·6%) | 0·40 (0·34–4·65) | p=0·46 |
| Maternal outcomes | ||||||||
| Pre-eclampsia | 122/2971 (4·1%) | 99/1469 (6·7%) | 0·75 (0·26–2·19) | p=0·60 | 1/48 (2·1%) | 0/40 (0·0%) | NA | NA |
| Unassisted vaginal birth | 1860/3224 (57·7%) | 1121/1740 (64·4%) | 1·06 (0·80–1·39) | p=0·70 | 255/387 (65·9%) | 247/366 (67·5%) | 0·92 (0·67–1·25) | p=0·60 |
Data are n/N (%), unless otherwise specified. ORs were calculated by use of multilevel mixed-effects logistic regression, with study level as a fixed effect and adjustment for baseline bile acid concentration and maternal parity. aOR=adjusted odds ratio. NA=not applicable.