The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)
Status:
Terminated
Trial end date:
2018-07-19
Target enrollment:
Participant gender:
Summary
Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency
is associated with a high risk of perinatal morbidity with long-lasting sequelae and
mortality. Placental insufficiency is the result of abnormal formation and function of the
placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental)
arteries. There is currently no therapy available with demonstrated effectiveness. Evidence
suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful
outcomes.
Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy
perinatal survival.
Study design: Multicenter nationwide randomized placebo-controlled clinical trial.
Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal
growth restriction of likely placental origin, and with estimated significant likelihood of
perinatal death.
Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study
parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal
morbidity at term age.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard
clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected
medication-associated risks can't be excluded on beforehand.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development