Table 1 Model parameters informed by results from the EXPEDITE study (published [11] and unpublished data)
Model parameter | DVI (n = 680) | MVI (n = 678) |
|---|---|---|
Clinical efficacy (published [11] and unpublished observations) | ||
Median time to vaginal delivery per patient (hours) [11] | 32.8 | 21.5 |
Mean time to vaginal delivery per patient (hours) | 25.2 | 18.2 |
Proportion of women achieving vaginal delivery within 12 h (%) | 10 | 21 |
Proportion of women achieving vaginal delivery within 24 h (%) | 36 | 56 |
Proportion of women delivered by caesarean section due to a lack of efficacy (%) | 2 | 1 |
Safety (unpublished observations) | ||
Total adverse events (%) [11] | 2.6 % | 10.0 % |
Uterine tachysystole without fetal heart rate involvement (requiring treatment) (%) | 0.6 % | 1.9 % |
Uterine tachysystole with fetal heart rate involvement (late decelerations, bradycardia, or prolonged decelerations) (%) | 1.2 % | 6.0 % |
Postpartum haemorrhage (%) | 0.1 % | 0.0 % |
Meconium-stained liquor (%) | 0.6 % | 1.2 % |
NICU admission (%) | 0.1 % | 0.6 % |
Low Apgar score (%) | 0.0 % | 0.1 % |
Uterine rupture | 0.0 % | 0.1 % |
Neonatal acidosis (%) | 0.0 % | 0.1 % |