NCT01107782

Sildenafil and Uteroplacental Perfusion

Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.

Detailed description

Fetal growth retardation affects up to 8% of all pregnancies and has massive short term (increased fetal morbidity and mortality) and long-term (increased incidence of cardiovascular disorders in adulthood) health implications. Doppler waveform analysis of these pregnancies suggests compromised uteroplacental circulation and placental hypoperfusion. Our aim is to assess if sildenafil citrate could improve vasodilatation in FGR pregnancies. Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental perfusion in FGR. Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil citrate, may improve uterine blood flow .

Conditions

• Fetal Growth Retardation

Interventions

Type	Name	Description
DRUG	sildenafil	50 mg TDS orally until birth
DRUG	placebo	50mg tid

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-06-01
• Completion: 2012-01-01
• First posted: 2010-04-21
• Last updated: 2011-02-23

Locations

1 site across 1 country: Iran