drugset / Trial / NCT02442492

Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

NCT02442492

Phase 2/3 Terminated 21 enrolled University of British Columbia
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high risk of perinatal morbidity and mortality. In association with reduced circulating placental growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling of the maternal uteroplacental arteries. There is no known treatment for placental IUGR. Management involves intensive fetal surveillance with delivery with evidence of serious fetal compromise. However, remote from term, delivery is associated with significant perinatal mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of IUGR-affected pregnancies and may represent a novel therapy.

Timeline

Start
2017-01
Primary completion
2018-07
Completion
2019-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sildenafil Unknown 25 mg Oral