Table 4.
Prespecified labour and birth outcomes in women with BMI ≥25 at trial entry by treatment group. Values are numbers (%) of women and treatment effects are relative risks based on imputed data unless otherwise indicated
| Outcome | Lifestyle advice (n=1075*) | Standard care (n=1067*) | Treatment effect (95% CI), P value | |
|---|---|---|---|---|
| Preterm birth | 62 (6) | 83 (8) | 0.75 (0.54 to 1.03), 0.07 | 0.74 (0.54 to 1.02), 0.07 |
| Chorioamnionitis requiring antibiotics | 27 (3) | 33 (3) | 0.81 (0.49 to 1.34), 0.41 | 0.78 (0.48 to 1.29), 0.34 |
| Induction of labour | 390 (36) | 378 (35) | 1.02 (0.91 to 1.15), 0.68 | 1.03 (0.92 to 1.15), 0.63 |
| Antibiotics during labour | 439 (41) | 454 (43) | 0.96 (0.87 to 1.06), 0.43 | 0.97 (0.88 to 1.07), 0.57 |
| Caesarean section | 370 (34) | 389 (37) | 0.94 (0.84 to 1.06), 0.33 | 0.95 (0.85 to 1.06), 0.34 |
| Postpartum haemorrhage >600 mL | 168 (18) | 177 (17) | 0.94 (0.77 to 1.14), 0.53 | 0.94 (0.77 to 1.14), 0.50 |
| 3rd/4th degree perineal trauma | 28 (3) | 20 (2) | 1.37 (0.78 to 2.43), 0.28 | 1.36 (0.77 to 2.40), 0.29 |
| Wound infection | 32 (3) | 30 (3) | 1.05 (0.65 to 1.72), 0.83 | 1.04 (0.64 to 1.70), 0.87 |
| Endometritis | 12 (1) | 10 (1) | 1.18 (0.51 to 2.72), 0.70 | 1.18 (0.51 to 2.72), 0.69 |
| Postpartum antibiotics | 99 (9) | 98 (9) | 1.00 (0.76 to 1.31), 1.00 | 0.98 (0.75 to 1.28), 0.90 |
| Mean (SD) postnatal length of stay (mother) (days)‡ | 2.85 (1.79) | 2.91 (1.71) | 0.98 (0.93 to 1.03), 0.37 | 0.97 (0.93 to 1.02), 0.31 |
| Thromboembolic disease | 1 (0.1) | 2 (0.2) | NA, 0.62§ | NA |
NA=not applicable.
*Includes all liveborn infants.
†Adjusted analyses included stratification variables BMI category, parity, and centre.
‡Treatment effects are ratios of means based on imputed data.
§P value derived Fisher’s exact test.