Table 2.
Delivery outcomes in intention-to-treat population. Values are numbers (percentages) unless stated otherwise
| Outcomes | Induction of labour (n=900) | Expectant management (n=901) | Relative risk (95% CI) | P value |
|---|---|---|---|---|
| Median (interquartile range) gestational age delivery (days) | 287 (287-288) | 289 (287-292) | −2.1 (−2.3 to −1.9)* | <0.001† |
| Mean (SD) time from randomisation to delivery (days) | 2.1 (1.6) | 4.2 (3.0) | −2.2 (−2.5 to −2.0)* | <0.001† |
| Level of care at onset of labour: | ||||
| Primary | 255 (28.3) | 619 (68.7) | NC | - |
| Secondary | 645 (71.7) | 282 (31.3) | NC | - |
| Onset of labour: | ||||
| Spontaneous (reference) | 260 (28.9) | 664 (73.7) | 1.00 | - |
| Induction | 640 (71.1) | 237 (26.3) | 2.70 (2.41 to 3.04) | <0.001 |
| Mode of induction: | n=640 | n=237 | ||
| Cervical ripening (catheter/prostaglandins) | 382 (59.7) | 132 (55.7) | 1.07 (0.94 to 1.22) | 0.30 |
| Amniotomy without oxytocin | 87 (13.6) | 34 (14.8) | 0.95 (0.66 to 1.37) | 0.77 |
| Amniotomy with oxytocin | 156 (24.4) | 59 (24.9) | 0.98 (0.76 to 1.27) | 0.87 |
| Indication for induction: | ||||
| Randomisation | 634 (99.1) | 0 (0.0) | NC | - |
| Post-term pregnancy | 0 (0.0) | 85 (35.9) | NC | - |
| Fetal condition | 5 (0.8) | 37 (15.6) | NC | - |
| Maternal condition | 0 (0.0) | 23 (9.7) | NC | - |
| Elective or maternal request | 1 (0.2) | 87 (36.7) | NC | - |
| Membranes ruptured >24 h | 0 (0.0) | 4 (1.7) | NC | - |
| Other | 0 (0.0) | 1 (0.4) | NC | - |
| Use of oxytocin | 533 (59.2) | 355 (39.4) | 1.50 (1.36 to 1.66) | <0.001 |
| Use of tocolytics | 28 (3.1) | 16 (1.8) | 1.75 (0.95 to 3.22) | 0.07 |
| Maternal intrapartum infection: | n=900 | n=901 | ||
| Fever during labour (≥38°C) | 50 (5.6) | 46 (5.1) | 1.09 (0.74 to 1.61) | 0.67 |
| Use of antibiotics | 48 (5.3) | 35 (3.9) | 1.37 (0.90 to 2.10) | 0.14 |
| Meconium stained amniotic fluid | 147 (16.3) | 205 (22.8) | 0.72 (0.59 to 0.87) | 0.001 |
| Level of care at time of birth: | ||||
| Primary | 129 (14.3) | 309 (34.3) | NC | - |
| Secondary | 771 (85.7) | 592 (65.7) | NC | - |
| Mode of delivery: | ||||
| Spontaneous vaginal | 710 (78.9) | 696 (77.2) | 1.02 (0.97 to 1.07) | 0.40 |
| Operative vaginal | 93 (10.3) | 108 (12.0) | 0.86 (0.66 to 1.12) | 0.27 |
| (Secondary) caesarean section | 97 (10.8) | 97 (10.8) | 1.00 (0.77 to 1.31) | 0.99 |
| Indication successful operative vaginal delivery: | n=93 | n=108 | ||
| Failure to progress at second stage | 39 (41.9) | 49 (45.4) | 0.92 (0.67 to 1.27) | 0.63 |
| Suspected fetal distress | 43 (46.2) | 37 (34.3) | 1.35 (0.96 to 1.90) | 0.08 |
| Suspected fetal distress and failure to progress | 10 (10.8) | 22 (20.4) | 0.53 (0.26 to 1.06) | 0.07 |
| Maternal complication or other | 1 (1.1) | 0 (0.0) | NA | - |
| Indication for secondary caesarean section: | n=97 | n=97 | ||
| Failure to progress at first stage | 29 (29.9) | 21 (21.6) | 1.38 (0.85 to 2.25) | 0.19 |
| Failure to progress at second stage | 12 (12.4) | 18 (18.6) | 0.67 (0.34 to 1.31) | 0.24 |
| Failed operative vaginal delivery | 6 (6.2) | 12 (12.4) | 0.50 (0.20 to 1.28) | 0.22‡ |
| Suspected fetal distress | 24 (24.7) | 21 (21.6) | 1.14 (0.68 to 1.91) | 0.61 |
| Suspected fetal distress and failure to progress at first stage | 7 (7.2) | 8 (8.3) | 0.75 (0.17 to 3.26) | 1.00‡ |
| Suspected fetal distress and failure to progress at second stage | 4 (4.1) | 3 (3.1) | 1.00 (0.26 to 3.88) | 1.00‡ |
| Maternal complication or other | 15 (15.5) | 14 (14.4) | 0.93 (0.48 to 1.83) | 0.84 |
NC=not calculable; NA=not applicable.
*
Mean (95% confidence interval) difference between groups.
†
Mann-Whitney U test.
‡
Fisher’s exact test.