Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

• Status: Terminated
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Gestational age from 18+0 - 27+6 weeks

AND

• EO IUGR, defined as

1. ultrasound (U/S) measurement of the fetal abdominal circumference (AC) <10th percentile for gestational age and/or documented reduced fetal growth velocity complicating either a prior EO IUGR with adverse perinatal outcome or abnormal uterine artery waveform in the index pregnancy;

OR

2. U/S estimate of fetal weight (EFW) <700g

AND

• Serum PlGF < 5th percentile for gestational age

Exclusion Criteria:

• known fetal aneuploidy

• known fetal anomaly/syndrome/congenital infection confirmed at the time of enrolment

• decision made to terminate pregnancy

• current cocaine or vasoconstrictor use (e.g. crystal meth) (risk of acute cardiac events)

• contraindication to sildenafil therapy, e.g. known significant maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil

• known HIV positive status (due drug-drug interaction between sildenafil and antiretrovirals)

• receiving peripheral alpha-blockers (e.g. prazosin)

• prior participation in a STRIDER trials

• pre-eclampsia or gestational hypertension diagnosed