Table 2.
Maternal and neonatal outcomes (per protocol population).
| D24 Dilapan-S 24 h (N = 96) | D12 Dilapan-S 12 h (N = 88) | Dilapan-S All (N = 184) | P24 Propess (N = 87) | |
|---|---|---|---|---|
| Primary outcome | ||||
| Vaginal delivery | ||||
| Yes | 72 (75%) | 56 (64%) | 128 (70%) | 66 (76%) |
| No | 24 (25%) | 32 (36%) | 56 (30%) | 21 (24%) |
| Secondary outcomes (maternal) | ||||
| Gestational age at delivery (weeks) | 40 [39,40] | 39 [39,40] | 39 [39,40] | 39 [39,40] |
| Induction commencement to delivery time (hours) | 47 [42,58] | 35 [31,46] | 43 [33,52] | 42 [29,52] |
| Time from removal of induction agent to delivery time (hours)e | 22 [18,32] | 20 [15,29] | 21 [16,31] | 20 [10,29] |
| Delivery within 48 h of starting IOL | 53 (55%) | 72 (82%) | 125 (68%) | 55 (63%) |
| Delivery within 72 h of starting IOL | 85 (89%) | 86 (98%) | 171 (93%) | 83 (95%) |
| Vaginal delivery timing | ||||
| Within 36 h | 10 (10%) | 33 (38%) | 43 (23%) | 27 (31%) |
| Within 48 h | 42 (44%) | 47 (53%) | 89 (48%) | 48 (55%) |
| Within 72 h | 65 (68%) | 55 (63%) | 120 (65%) | 65 (75%) |
| Mode of Delivery | ||||
| SVD | 40 (42%) | 33 (38%) | 73 (40%) | 38 (44%) |
| OVD | 32 (33%) | 23 (26%) | 55 (30%) | 28 (32%) |
| Caesarean delivery | 24 (25%) | 32 (36%) | 56 (30%) | 21 (24%) |
| Indication for emergency intrapartum CSa | ||||
| Failure to progress | 7 (32%) | 12 (38%) | 19 (10%) | 10 (53%) |
| Abnormal CTG | 10 (45%) | 12 (38%) | 22 (12%) | 8 (42%) |
| Failed IOL | 4 (18%) | 7 (22%) | 11 (6%) | 1 (5%) |
| Maternal request | 1 (5%) | 1 (3%) | 2 (1%) | 0 |
| Indication for emergency pre-labour CSa | ||||
| Abnormal CTG | 2 (100%) | 0 | 2 (1%) | 1 (50%) |
| Maternal request | 0 | 0 | 0 | 1 (50%) |
| Shoulder dystocia | 1 (1%) | 1 (1%) | 2 (1%) | 1 (1%) |
| Obstetric anal sphincter injury | 3 (3%) | 1 (1%) | 4 (2%) | 4 (5%) |
| Postpartum haemorrhage >1,000 mls | 4 (4%) | 6 (7%) | 10 (5%) | 7 (8%) |
| Hyperstimulation | 0 | 0 | 0 | 3 (3%) |
| Epidural use | 82 (85%) | 79 (90%) | 161 (88%) | 74 (85%) |
| Hospital stay: Return-visitb to discharge (hours) | 79 [59,104] | 88 [67,111] | 83 [64,105] | 76 [56,98] |
| Secondary outcomes (neonatal) | ||||
| Liveborn | ||||
| Yes | 96 (100%) | 88 (100%) | 184 (100%) | 87 (100%) |
| No | 0 | 0 | 0 | 0 |
| Birthweight (g) | 3507 (353) | 3408 (392) | 3460 (374) | 3473 (307) |
| Apgar <7 at 5 min | 1 (1%) | 2 (2%) | 3 (2%) | 0 |
| NICU admission | 7 (7%) | 4 (5%) | 11 (6%) | 3 (3%) |
| Cord pH (arterial)c | 7.2 (0.1) | 7.2 (0.1) | 7.2 (0.1) | 7.2 (0.1) |
| Cord pH (venous)d | 7.1 (0.8) | 7.3 (0.1) | 7.2 (0.6) | 7.3 (0.1) |
| Antibiotics for suspected infection | 10 (10%) | 6 (7%) | 16 (9%) | 7 (8%) |
| Antibiotics for confirmed infection | 1 (1%) | 0 | 1 (<1%) | 0 |
Results presented are: n (%), mean (SD) and median [IQR].
SVD = spontaneous vaginal delivery; OVD = operative vaginal delivery; CTG = cardiotocograph; NICU = neonatal intensive care unit.
Percentages are based on those with emergency intrapartum or pre-labour CS.
Denotes time in hours from when the patient was re-admitted to hospital after their return with Propess or Dilapan-S in situ, until time of discharge after delivery.
Cord pH (arterial) was recorded in 45, 41 and 44 patients in the D24, D12 and P24 groups, respectively.
Cord pH (venous) was recorded in 48, 42 and 43 patients in the D24, D12 and P24 groups, respectively.
Removal time was missing for 1 patient in the D12 group and 1 patient in the P24 group.