Table 2.
Maternal outcomes. Values are numbers (percentages) unless stated otherwise
| Maternal outcomes | Study population | Relative risk (95% CI) | P value | |
|---|---|---|---|---|
| Discontinued (n=607) | Continued (n=591) | |||
| Primary outcome | ||||
| Caesarean section | 101 (16.6) | 84 (14.2) | 1.17 (0.90 to 1.53) | 0.25 |
| Secondary maternal outcomes | ||||
| Indication for caesarean section*: | - | - | ||
| Dystocia | 62 (10.2) | 58 (9.8) | ||
| Suspicion of fetal asphyxia | 26 (4.3) | 13 (2.2) | - | - |
| Suspicion of uterine rupture | 3 (0.5) | 1 (0.2) | - | - |
| Chorioamnionitis | 2 (0.3) | 1 (0.2) | - | - |
| Other | 8 (1.3) | 11 (1.9) | - | - |
| Assisted vaginal delivery (use of forceps or vacuum) | 64 (10.5)† | 67 (11.3)† | 0.93 (0.67 to 1.28) | 0.66 |
| Median (IQR) duration from start of initial oxytocin infusion to delivery, min | 535 (314-797) | 477 (272-727) | - | 0.01 |
| Median (IQR) duration from time of randomisation to delivery, min | 282 (119-484) | 203 (77-397) | - | <0.001 |
| Median (IQR) duration of second stage of labour* ‡, min | 95 (31-198) | 78 (29-182) | - | 0.07 |
| Epidural use: | 386 (63.6) | 350 (59.2) | 1.07 (0.98 to 1.17) | 0.14 |
| Before randomisation | 304 (50.1) | 295 (49.9) | 1.00 (0.90 to 1.12) | 0.95 |
| After randomisation | 83 (13.7) | 57 (9.6) | 1.42 (1.03 to 1.95) | 0.03 |
| Uterine tachysystole during labour: | ||||
| Before intervention | 61/599 (10.2) | 80/585 (13.7) | 0.74 (0.54 to 1.02) | 0.06 |
| During intervention | 20/546 (3.7) | 70/541 (12.9) | 0.28 (0.17 to 0.46) | <0.001 |
| Third or fourth degree perineal tears§ | 25/506 (4.9) | 27/507 (5.3) | 0.92 (0.54 to 1.57) | 0.76 |
| Postpartum haemorrhage within 24 h: | (n=605) | (n=590) | ||
| >1000 mL | 84 (13.8) | 102 (17.3) | 0.80 (0.61 to 1.05) | 0.10 |
| >1500 mL | 43 (7.1) | 51 (8.6) | 0.82 (0.56 to 1.21) | 0.32 |
| Postpartum blood transfusion | 8 (13.2) | 11 (18.6) | 0.71 (0.29 to 1.75) | 0.45 |
| Evacuation of retained tissue | 39/605 (7.7) | 45/590 (8.9) | 0.86 (0.58 to 1.31) | 0.50 |
| Maternal pyrexia during labour* | 70/606 (11.6) | 52/591 (8.8) | 1.31 (0.93 to 1.85) | 0.12 |
| Uterine rupture | 0 | 0 | .. | .. |
| Urinary retention¶ | 25/601 (4.2) | 20/586 (3.4) | 1.22 (0.68 to 2.17) | 0.50 |
| Puerperal infection during admission** | 26/601 (4.3) | 27/591 (4.6) | 0.95 (0.56 to 1.60) | 0.83 |
| Postpartum hospital stay: | ||||
| ≤2 days | 261 (43.0) | 284 (48.1) | 0.89 (0.79 to 1.10) | 0.08 |
| >2 days | 346 (57.0) | 307 (51.9) | 1.10 (0.99 to 1.22) | 0.08 |
| Exclusive breast feeding at discharge* | 403/589 (68.4) | 378/569 (66.4) | 1.03 (0.95 to 1.12) | 0.47 |
| Readmission within 7 days: | 31/605 (5.1) | 41/589 (7.0) | 0.74 (0.47 to 1.16) | 0.18 |
| Puerperal infection†† | 11 (1.8) | 9 (1.5) | - | - |
| Bowel obstruction | 1 (0.2) | 2 (0.4) | - | - |
| Thrombo-embolic complication | 0 | 1 (0.2) | - | - |
| Other‡‡ | 19 (3.1) | 29 (4.9) | - | - |
| Maternal death within 7 days | 0 | 0 | - | - |
The following pre-specified secondary outcome measures were not collected owing to logistical difficulties: breast feeding (time to establishment and duration of exclusive breast feeding), episiotomy, dose and duration of oxytocin stimulation, and time of birth of placenta.
Number of missing data: Hyperstimulation prior to intervention=14, Hyperstimulation after intervention=111, Postpartum haemorrhage=3, Maternal pyrexia during labour=1, Urinary retention=11, Puerperal infection during admission=6, Exclusive breastfeeding=40, Readmission within 7 days=4.
Not a pre-specified outcome measure.
All vacuum extractions except for one forceps delivery.
Reported for those reaching this stage of labour.
Vaginal deliveries only.
No spontaneous urination 6 h after vaginal delivery or 6 h after removal of catheter if caesarean section.
Two confirmed maternal temperatures of ≥38°C at least 4 h apart.
Endometritis, urinary tract infection, and wound infection.
Suspected infection, to accompany sick neonate, or pre-eclampsia/eclampsia.