Sildenafil for early severe fetal growth restriction

The Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset intrauterine growth Restriction) Trial - Dutch STRIDER

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004112-63-NL

Enrollment

354

Registered

2014-07-24

Start date

2014-08-13

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal growth restriction

Interventions

Trade Name: Viagra Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria ((I OR II) AND III): I. at 200-276 weeks: an ultrasound measurement of the fetal abdominal circumference (AC) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: I. Plan to terminate pregnancy for maternal or fetal indication within days II. Known multiple pregnancy III. identified congenital anomalies or congenital infection IV. Maternal age at eligibility <18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival, in women with singleton pregnancies with severe fetal growth restriction of placental origin.;Secondary Objective: The secondary objectives of study are 1) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC); 2) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score); 3) to assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome ;Primary end point(s): The Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) Trial is a double-blind randomised controlled trial (RCT) designed to evaluate whether in pregnant women with severe early-onset FGR of placental origin, Sildenafil citrate compared with placebo increases the likelihood of intact perinatal survival until term age. This is defined by the survival to term age without evidence of either severe central nervous system (CNS) injury (by ultrasound and/or magnetic resonance imaging [MRI]) or non-CNS severe morbidity (bronchopulmonary dysplasia, retinopathy of prematurity, or necrotising enterocolitis requiring surgery). ;Timepoint(s) of evaluation of this end point: Term age	—

Measure

Time frame

Main Objective: We aim to evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival, in women with singleton pregnancies with severe fetal growth restriction of placental origin.;Secondary Objective: The secondary objectives of study are 1) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC); 2) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score); 3) to assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome ;Primary end point(s): The Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) Trial is a double-blind randomised controlled trial (RCT) designed to evaluate whether in pregnant women with severe early-onset FGR of placental origin, Sildenafil citrate compared with placebo increases the likelihood of intact perinatal survival until term age. This is defined by the survival to term age without evidence of either severe central nervous system (CNS) injury (by ultrasound and/or magnetic resonance imaging [MRI]) or non-CNS severe morbidity (bronchopulmonary dysplasia, retinopathy of prematurity, or necrotising enterocolitis requiring surgery). ;Timepoint(s) of evaluation of this end point: Term age

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary objectives of study are 1) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC); 2) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score); 3) to assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome Announced subgroup analyses: to evaluate the effect of Sildenafil on the abovementioned outcome measures, in subgroups defined by a) an abnormal or normal serum level of placental growth factor (PlGF); b) absent/reversed umbilical arterial end diastolic flow (REDF) at commencement of treatment; c) other patient characteristics available at baseline such as gestational age, estimated fetal weight;;Timepoint(s) of evaluation of this end point: Term age and 2 years	—

Measure

Time frame

Secondary end point(s): The secondary objectives of study are 1) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC); 2) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score); 3) to assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome Announced subgroup analyses: to evaluate the effect of Sildenafil on the abovementioned outcome measures, in subgroups defined by a) an abnormal or normal serum level of placental growth factor (PlGF); b) absent/reversed umbilical arterial end diastolic flow (REDF) at commencement of treatment; c) other patient characteristics available at baseline such as gestational age, estimated fetal weight;;Timepoint(s) of evaluation of this end point: Term age and 2 years

—

Countries

Netherlands

Contacts

Public ContactObs/gyn Consortium

Academic Medical Center

info@studies-obsgyn.nl31205663857

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026