Table 1.
Baseline characteristics.
| Characteristic | ITT |
Per-Protocol Population |
|||
|---|---|---|---|---|---|
| All (N = 327) | All (N = 271) | D24 Dilapan-S 24 h (N = 96) | D12 Dilapan-S 12 h (N = 88) | P24Propess (N = 87) | |
| Maternal age (years) | |||||
| 18–24 | 116 (35%) | 98 (36%) | 39 (41%) | 32 (36%) | 27 (31%) |
| 25–30 | 94 (29%) | 76 (28%) | 24 (25%) | 22 (25%) | 30 (34%) |
| 30–39 | 117 (36%) | 97 (36%) | 33 (34%) | 34 (39%) | 30 (34%) |
| Mean (SD) | 27.3 (5.1) | 27.2 (5.1) | 27.1 (5.2) | 27.4 (5.3) | 27.3 (4.8) |
| Min-Max | 18–39 | 18–39 | 18–38 | 18–39 | 19–38 |
| Maternal height (m)a | |||||
| Mean (SD) | 166 (6.2) | 166 (6.1) | 166 (5.5) | 166 (6.2) | 167 (6.6) |
| Maternal weight (kg) | |||||
| Mean (SD) | 70.4 (12) | 71.2 (12) | 71.8 (13) | 71.0 (12) | 70.9 (13) |
| BMI (kg/m2)a | |||||
| 18.0–24.9 | 162 (50%) | 130 (48%) | 45 (47%) | 43 (49%) | 42 (48%) |
| 25.0–29.9 | 115 (35%) | 96 (35%) | 35 (36%) | 30 (34%) | 31 (36%) |
| 30.0–34.9 | 49 (15%) | 45 (17%) | 16 (17%) | 15 (17%) | 14 (16%) |
| Mean (SD) | 25.5 (3.9) | 25.7 (4.0) | 25.9 (4.1) | 25.7 (3.8) | 25.5 (4.0) |
| Min-Max | 18.2–34.9 | 18.4–34.9 | 18.4–34.7 | 19.3–34.9 | 18.5–34.7 |
| Medical history | |||||
| Anaemia | 1 (<1%) | 1 (<1%) | 1 (1%) | 0 | 0 |
| Anxiety | 5 (2%) | 4 (1%) | 1 (1%) | 2 (2%) | 1 (1%) |
| Asthma | 12 (4%) | 10 (4%) | 5 (5%) | 3 (3%) | 2 (2%) |
| Depression | 5 (2%) | 5 (2%) | 3 (3%) | 1 (1%) | 1 (1%) |
| Hyperthyroidism | 1 (<1%) | 1 (<1%) | 0 | 0 | 1 (1%) |
| Hypothyroidism | 12 (4%) | 12 (4%) | 4 (4%) | 4 (5%) | 4 (5%) |
| Uterine fibroids | 2 (1%) | 2 (1%) | 1 (1%) | 0 | 1 (1%) |
| Recurrent UTI | 3 (1%) | 3 (1%) | 1 (1%) | 2 (2%) | 0 |
| COVID-19 | 49 (15%) | 46 (17%) | 14 (15%) | 17 (19%) | 15 (17%) |
| Other | 17 (5%) | 15 (6%) | 8 (8%) | 6 (7%) | 1 (1%) |
| Gestational age at screening (weeks) | |||||
| Mean (SD) | 38.5 (0.5) | 38.5 (0.5) | 38.6 (0.5) | 38.5 (0.4) | 38.5 (0.5) |
| Gestational age at induction (weeks) | |||||
| Mean (SD) | 39.2 (0.2) | 39.3 (0.2) | 39.2 (0.2) | 39.2 (0.2) | |
| Bishop Scoreb | |||||
| Median [IQR] | 1 [0,2] | 1 [0,2] | 1 [1,2] | 1 [0,2] | |
ITT, Intention-to-treat population; UTI, urinary tract infection; IQR, inter-quartile range.
a
Maternal height, and subsequently, BMI was not recorded for one patient in the D12 group (ITT population but not in the per-protocol population).
b
One patient in the D24 group had Bishop score recorded as “<6” at baseline and excluded from the statistical summaries.