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Table 2 Maternal and fetal/neonatal outcomes

From: Detailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restriction

 

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

         

 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 (%)

         

Preeclampsia (%)

         

HELLP syndrome (%)

         

Maternal use of antihypertensive treatment antenatal or postnatal

 One antihypertensive

         

 Two antihypertensives

         

 Three or more antihypertensives

         

Maternal need for magnesium sulphate for hypertension (%)

         

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 (%)

         

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 (%)

         
  1. GA gestational age, EFW estimated fetal weight, HELLP haemolysis, elevated liver enzymes, and low platelets syndrome, IVH intraventricular hemorrhage, PVL periventricular leukomalacia, BPD bronchopulmonary dysplasia, ROP retinopathy of prematurity, NEC necrotising enterocolitis