TerminatedPhase 2/3

Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

Stopped: Trial terminated following Dutch DSMB recommendation for their Study

Canada21 participantsStarted 2017-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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;
✓. U/S estimate of fetal weight (EFW) \<700g

What they're measuring

compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups

Timeframe: 6 weeks after postpartum

Trial details

NCT IDNCT02442492

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07

View on ClinicalTrials.gov More Intrauterine Growth Restriction (IUGR) trials