Table 3.
Process outcomes after trial entry
| Decision support (n=22 517) | No decision support*(n=22 564) | Adjusted effect measure (99% CI) | ||
|---|---|---|---|---|
| Epidural analgesia | ||||
| Yes | 2770 (27·3%) | 2689 (26·5%) | Risk ratio 1·03 (99% CI 0·97–1·09) | |
| No | 7383 (72·7%) | 7453 (73·5%) | ·· | |
| Unknown† | 12 364 | 12 422 | ·· | |
| Labour augmentation | ||||
| Yes | 2705 (30·9%) | 2750 (31·3%) | Risk ratio 0·99 (99% CI 0·93–1·04) | |
| No | 6047 (69·1%) | 6042 (68·7%) | ·· | |
| Unknown† | 13 765 | 13 772 | ·· | |
| Presence of meconium | ·· | ·· | ||
| Yes | 440 (4·5%) | 469 (4·8%) | Risk ratio 0·94 (99% CI 0·80–1·11) | |
| No | 9316 (95·5%) | 9346 (95·2%) | ·· | |
| Unknown† | 12 761 | 12 749 | ·· | |
| At least one blue, yellow, or red level of concern | 21 950 (97·5%) | 22 021 (97·6%) | Risk ratio 1·00 (99% CI 1·00–1·00) | |
| At least one blue level of concern (mild abnormality) | 21 863 (97·1%) | 21 913 (97·1%) | Risk ratio 1·00 (99% CI 1·00–1·00) | |
| At least one yellow level of concern (moderate abnormality) | 16 765 (74·5%) | 16 722 (74·1%) | Risk ratio 1·00 (99% CI 0·99–1·02) | |
| At least one red level of concern (severe abnormality) | 2335 (10·8%) | 2413 (11·1%) | Risk ratio 0·97 (99% CI 0·90–1·04) | |
| Unknown‡ | 822 | 833 | ·· | |
| Blue, yellow, or red levels of concern in women with at least one level of concern | ||||
| Median | 9 (5–15) | 9 (5–15) | ·· | |
| Rate (per h) | 1·37 | 1·40 | Rate ratio 0·98 (99% CI 0·96–1·00) | |
| Unknown§ | 765 | 824 | ||
| Blue levels of concern in women with a blue level | ||||
| Median | 7 (4–11) | 7 (4–11) | ·· | |
| Rate (per h) | 1·06 | 1·05 | Rate ratio 1·01 (99% CI 0·99–1·03) | |
| Unknown§ | 740 | 800 | ·· | |
| Yellow levels of concern in women with a yellow level | ||||
| Median | 2 (1–4) | 2 (1–5) | ·· | |
| Rate (per h) | 0·35 | 0·40 | Rate ratio 0·87 (99% CI 0·84–0·89) | |
| Unknown§ | 354 | 421 | ·· | |
| Red levels of concern in women with a red level | ||||
| Median | 1 (1–1) | 1 (1–1) | ·· | |
| Rate (per h) | 0·14 | 0·14 | Rate ratio 0·98 (99% CI 0·92–1·04) | |
| Unknown‡§ | 41 | 55 | ·· | |
| Interaction with Guardian system¶ | ||||
| Median | 5 (0–16) | 4 (0–15) | ·· | |
| Rate (per h) | 4·22 | 4·21 | Rate ratio 0·99 (99% CI 0·95–1·03) | |
| Unknown | 1723 | 1603 | ·· | |
| Vaginal examinations | ||||
| Median | 2 (1–3) | 2 (1–3) | ·· | |
| Rate (per h) | 0·28 | 0·27 | Rate ratio 1·03 (99% CI 1·00–1·05) | |
| Unknown | 877 | 929 | ·· | |
| Time from last red level of concern to delivery (mins) | ||||
| Median | 58 (13–279) | 58 (13–264) | HR 0·99 (99% CI 0·92–1·06) | |
| Unknown‡ | 822 | 823 | ·· | |
Data are n (%), n, or median (IQR), unless otherwise specified. Women with no labour or seemingly randomised after delivery were not included in calculations in this table, which is why the denominators differ from those in the footnotes of table 2. Effect measures were adjusted for stratification factors used in the randomisation (centre and twin birth) and clustering as a result of twins and multiple birth episodes. Crude effect measures are not presented as identical to one decimal place (two decimal places for most outcomes). CI=confidence interval. HR=hazard ratio.
For the control group with cardiotocographic monitoring only, decision-support software was used retrospectively to determine when an alert would have sounded.
These data were only recorded and uploaded for analysis from 2013 for most centres.
Data for timing of red level of concerns not available for two centres—Warwick (n=823) and Derby (n=832)·
Women with missing length of labour were not included in calculation of rates and rate ratios.
Measured via number of thumbprint entries from time of trial entry to first yellow level of concern, or until cervix fully dilated if no abnormality detected.