| Intention to treat | Intention to treat, adjusted for GA and EFW at inclusion | Per protocol | ||||||
---|---|---|---|---|---|---|---|---|---|
Sildenafil (n =) | Placebo (n =) | P value | Sildenafil (n =) | Placebo (n =) | P value | Sildenafil (n =) | Placebo (n =) | P value | |
Maternal outcomes | |||||||||
 Treatment duration (days) |  |  |  |  |  |  |  |  |  |
 Gestational age at delivery (weeks + days) |  |  |  |  |  |  |  |  |  |
 Pregnancy prolongation after randomisation (days) |  |  |  |  |  |  |  |  |  |
 Abdominal circumference at ultrasound closest to 2 weeks after randomisation (mm) |  |  |  |  |  |  |  |  |  |
Mode of delivery | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Caesarean section on fetal indication (%) |  |  |  |  |  |  |  |  |  |
 Caesarean section on maternal indication (%) |  |  |  |  |  |  |  |  |  |
 Induced vaginal delivery on fetal indication (%) |  |  |  |  |  |  |  |  |  |
 Induced vaginal delivery on maternal indication (%) |  |  |  |  |  |  |  |  |  |
 Spontaneous vaginal delivery (%) |  |  |  |  |  |  |  |  |  |
 Induction of labour after intra-uterine death (%) |  |  |  |  |  |  |  |  |  |
Pregnancy induced hypertension (%) | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Preeclampsia (%) | Â | Â | Â | Â | Â | Â | Â | Â | Â |
HELLP syndrome (%) | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Maternal use of antihypertensive treatment antenatal or postnatal | |||||||||
 One antihypertensive |  |  |  |  |  |  |  |  |  |
 Two antihypertensives |  |  |  |  |  |  |  |  |  |
 Three or more antihypertensives |  |  |  |  |  |  |  |  |  |
Maternal need for magnesium sulphate for hypertension (%) | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Neonate born between 48 h and 14 days after antenatal corticosteroids course (complete course) (%) |  |  |  |  |  |  |  |  |  |
Neonate born between 0 and 48 h after antenatal corticosteroids course (incomplete course) (%) |  |  |  |  |  |  |  |  |  |
Neonate born during maternal administration of intravenous magnesium sulphate (%) | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Fetal/neonatal outcomes | |||||||||
 Intra-uterine death (%) |  |  |  |  |  |  |  |  |  |
 Neonatal death (%) |  |  |  |  |  |  |  |  |  |
 Survival at hospital discharge (%) |  |  |  |  |  |  |  |  |  |
 Survival with relevant morbidity at hospital discharge (%) |  |  |  |  |  |  |  |  |  |
 Survival without relevant morbidity at hospital discharge (%) |  |  |  |  |  |  |  |  |  |
 Birth weight of neonates with intra-uterine death (grammes) |  |  |  |  |  |  |  |  |  |
 Birth weight of neonates with live birth (grammes) |  |  |  |  |  |  |  |  |  |
 Postmenstrual age at first discharge home (weeks + days) |  |  |  |  |  |  |  |  |  |
 IVH grade III or IV (%) |  |  |  |  |  |  |  |  |  |
 PVL grade II or more (%) |  |  |  |  |  |  |  |  |  |
 Moderate or severe BPD (%) |  |  |  |  |  |  |  |  |  |
 No BPD (%) |  |  |  |  |  |  |  |  |  |
 ROP treated by laser or surgery (%) |  |  |  |  |  |  |  |  |  |
 One or more culture-proven episode of infection or clinical episode of infection with antibiotic treatment necessary ≥ 5 days (%) |  |  |  |  |  |  |  |  |  |
 NEC grade II or more (%) |  |  |  |  |  |  |  |  |  |