Fetal growth restriction
Conditions
Interventions
Sildenafil 25mg or placebo tablet orally 3 times daily until fetal death,
delivery or 32 weeks of gestation (whichever comes first).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
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) <3rd percentile for gestational age or an ultrasound estimate of fetal weight (EFW) <5th percentile OR II. at 280-296 weeks: an ultrasound estimate of fetal weight (EFW) <700 grams AND III. likely placental origin defined by (a AND/OR b AND/OR c AND/OR d) a. the presence of uterine artery notching b. abnormal flow velocity patterns of the umbilical artery or middle cerebral artery c. maternal hypertensive disorders d. low PlGF in point-of-care assessment
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 |
|---|---|
| Perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term healthy survival; fetal growth during further pregnancy; incidence of maternal hypertensive disorders; | — |
Countries
Netherlands
Outcome results
None listed