Table 3.
Perinatal outcomes in intention-to-treat groups
| Outcomes | Induction of labour (n=900) | Expectant management (n=901) | Relative risk (95% CI) | P value |
|---|---|---|---|---|
| Composite adverse perinatal outcome* | 15 (1.7) | 28 (3.1) | 0.54 (0.29 to 1.00) | 0.045† |
| with 5 min Apgar score <4 instead of <7 | 4 (0.4) | 12 (1.3) | 0.33 (0.11 to 1.03) | 0.06† |
| including arterial pH <7.05 | 27 (3.0) | 37 (4.1) | 0.72 (0.44 to 1.20) | 0.16† |
| Stillbirth | 1 (0.1) | 2 (0.2) | 0.50 (0.05 to 5.51) | 1.00† |
| Neonatal death post partum | 0 (0.0) | 0 (0.0) | NA | - |
| Apgar score 5 mins post partum‡: | ||||
| <7 | 11 (1.2) | 23 (2.6) | 0.48 (0.23 to 0.98) | 0.038 |
| <4 | 0 (0.0) | 3 (0.3) | NA | - |
| Neonate admitted to: | ||||
| NICU | 3/899 (0.3) | 8/899 (0.9) | 0.38 (0.10 to 1.41) | 0.23† |
| Medium care | 59 (6.6) | 60 (6.7) | 0.98 (0.69 to 1.39) | 0.90 |
| Meconium aspiration syndrome§ | 0 (0.0) | 2 (0.2) | NA | - |
| Plexus brachialis injury | 0 (0.0) | 0 (0.0) | NA | - |
| Intracranial haemorrhage¶ | 0 (0.0) | 0 (0.0) | NA | - |
| Umbilical cord pH (arterial): | ||||
| <7.05 | 16 (1.8) | 12 (1.3) | 1.06 (0.51 to 2.20) | 0.88 |
| Missing | 557 (62,0) | 629 (70,0) | NA | - |
| Congenital abnormality | 16 (1.8) | 19 (2.1) | 0.84 (0.44 to 1.63) | 0.61 |
| Hypoglycaemia** | 3 (0.3) | 6 (0.7) | 0.50 (0.13 to 2.00) | 0.51† |
| Neonatal infection/sepsis†† | 37 (4.1) | 37 (4.1) | 1.00 (0.64 to 1.56) | 1.00 |
| Female | 453 (50.3) | 463 (51.4) | 0.98 (0.89 to 1.07) | 0.65 |
| Mean (SD) birthweight (g) | 3685 (417.4) | 3741 (430.0) | −56.6 (−95.8 to −17.4)‡‡ | 0.005 |
| Small for gestational age: | ||||
| <2.3rd centile | 13 (1.4) | 11 (1.2) | 1.18 (0.53 to 2.62) | 0.68 |
| <10th centilethcentile | 61 (6.8) | 62 (6.9) | 0.99 (0.70 to 1.39) | 0.93 |
| Large for gestational age: | ||||
| >90th centile | 86 (9.6) | 99 (11.0) | 0.87 (0.66 to 1.14) | 0.32 |
| >97th centile | 15 (1.7) | 27 (3.0) | 0.56 (0.30 to 1.04) | 0.07 |
NA=not applicable; NICU=neonatal intensive care unit.
Composite outcome defined as perinatal mortality (fetal death, intrapartum death, and neonatal death until 28 days) or perinatal morbidity (a 5 minute Apgar score <7, and/or meconium aspiration syndrome, and/or plexus brachialis injury, and/or intracranial haemorrhage, and/or NICU admission). In the induction group all live births with a composite adverse perinatal outcome (CAPO) had either a 5 minute Apgar score <7 or a NICU admission. In the expectant management group, livebirths with a CAPO: two neonates had meconium aspiration syndrome, 5 minute Apgar score <7, and NICU admission; three neonates were admitted to NICU and also had a 5 minute Apgar score <7; three neonates were admitted to NICU but had no 5 minute Apgar score <7; 18 neonates had a 5 minute Apgar score <7 but no NICU admission.
Fisher’s exact test.
Apgar score of live births.
Defined as respiratory distress after birth in presence of meconium stained amniotic fluid.
Defined as clinical signs of intracranial haemorrhage.
Defined as glucose concentration <1.9 mmol/L and need for intravenous glucose.
Defined as clinical suspected findings or proved positive blood culture result.
Mean (95% confidence interval) difference between groups.