Table 3.
Comparisons of maternal outcomes from randomisation until postnatal hospital discharge. Values are numbers (percentages) of women unless stated otherwise
| Event | Structured care (n=2497) | Usual care (n=2499) | Odds ratio (CI) |
|---|---|---|---|
| Labour onset: | |||
| Spontaneous | 2232 (89.4) | 2209 (88.4) | — |
| Induced | 255 (10.2) | 283 (11.3) | — |
| No labour | 8 (0.3) | 6 (0.2) | — |
| Oxytocin started after active labour | 1553 (62.2) | 1587 (63.5) | 0.95 (0.77 to 1.12)* |
| Analgesia or anaesthesia†: | |||
| Regional‡ | 2112 (84.6) | 2159 (86.4) | 0.85 (0.62 to 1.08)* |
| Intramuscular or intravenous opioid | 1126 (45.1) | 1078 (43.2) | — |
| Nitrous oxide | 167 (6.7) | 146 (5.8) | — |
| Pudendal, paracervical, saddle block | 8 (0.3) | 4 (0.2) | — |
| General | 16 (0.6) | 22 (0.9) | — |
| Other§ | 6 (0.2) | 2 (0.1) | — |
| None | 112 (4.5) | 112 (4.5) | 1.06 (0.54 to 1.58)* |
| Continuous electronic fetal heart rate monitoring | 2117 (84.8) | 2160 (86.4) | 0.84 (0.59 to 1.08)* |
| Method of delivery: | |||
| Spontaneous vaginal delivery | 1597 (64.0) | 1533 (61.3) | 1.12 (0.96 to 1.27)* |
| Instrumental vaginal delivery | 341 (13.7) | 362 (14.5) | — |
| Vacuum | 231 | 240 | — |
| Forceps (low or mid) | 110 | 122 | — |
| Caesarean delivery | 559 (22.4) | 604 (24.2) | 0.90 (0.71 to 1.10)* |
| Perineal trauma requiring suturing: | 1336 (53.5) | 1350 (54.0) | 0.98 (0.82 to 1.13)* |
| Episiotomy | 569 | 573 | — |
| Second degree laceration | 764 | 790 | — |
| Third or fourth degree laceration | 131 | 111 | — |
| Other | 3 | 0 | — |
| Maternal death | 1¶ | 0 | — |
| Health problems during postnatal stay: | |||
| Postnatal fever | 24 (1.0) | 23 (0.9) | — |
| Haemorrhage >1000 ml | 51 (2.0) | 49 (2.0) | — |
| Transfusion given | 13 (0.5) | 7 (0.2) | — |
| Other** | 10 (0.4) | 4 (0.2) | — |
| Length of postnatal hospital stay, median (interquartile range), hours | 50.1 (41.4, 63.5) | 50.3 (41.2, 64.1), P=0.75‡‡ | — |
*Spontaneous vaginal delivery was primary outcome; prespecified confidence interval 95%. Oxytocin, regional analgesia, electronic fetal heart rate monitoring, and caesarean delivery were “other” outcomes; prespecified confidence interval 99.5%. Perineal trauma requiring suturing was a secondary outcome; prespecified confidence interval 98.75%.
†Some women had more than one form of analgesia or anaesthesia.
‡Epidural analgesia, combined spinal anaesthesia and epidural, or spinal anaesthesia.
§Sterile water injections (n=7) and intrathecal opioid (n=1).
¶Due to undetected haemorrhage from uterine artery after caesarean delivery. Data safety and monitoring committee concluded that death was unrelated to the trial.
**Such as hospital acquired pneumonia; severe pregnancy induced hypertension; septic pelvic thrombophlebitis; severe endometriosis; major delivery complications (tear of small bowel, cystostomy, bladder tear, severe bleeding requiring laparotomy, hysterectomy).
‡‡Prespecified “other” outcome.