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

Table 1 Baseline criteria

	Sildenafil (n =)	Placebo (n =)
Age (years)
BMI (kg/m²)
Ethnicity
Caucasian (%)
African descent (%)
Asian (%)
Other (%)
Highest completed educational level mother
High (%)
Middle (%)
Low (%)
Unknown (%)
Highest completed educational level father/partner
High (%)
Middle (%)
Low (%)
Unknown (%)
Language spoken at home
Only Dutch
Only other language than Dutch
More than one language, including Dutch
Maternal smoking (%)
Gestational age at inclusion (weeks + days)
Estimated fetal weight at ultrasound (gram)
Fetal abdominal circumference at ultrasound (mm)
Notching uterine artery (one-or two-sided) (%)
PI umbilical artery > 95th centile (%)
PI middle cerebral artery < 5th centile (%)
End-diastolic flow
Positive (%)
Absent (%)
Reversed (%)
Pregnancy-induced hypertension (%)
Preeclampsia (%)
HELLP syndrome (%)
Systolic blood pressure (mmHg)
Diastolic blood pressure (mmHg)

BMI body mass index, PI pulsatility index, HELLP haemolysis, elevated liver enzymes, and low platelets syndrome

ISSN: 1745-6215