Clinical Trial: Sildenafil and Uteroplacental Perfusion
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil
Brief Summary: The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.
Detailed Summary:
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 .
Sponsor: Tehran University of Medical Sciences
Current Primary Outcome: Uteroplacental Perfusion [ Time Frame: 2 hours after sildenafil ingestion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- fetal growth [ Time Frame: after 6 months ]
- umbilical artery blood gass assessment [ Time Frame: immediately after birth ]
- effect on fetal well being [ Time Frame: 2 hours after sildenafil ]when BP score is<8 we repeat it after sildenafil ingestion
Original Secondary Outcome: Same as current
Information By: Tehran University of Medical Sciences
Dates:
Date Received: January 13, 2010
Date Started: June 2008
Date Completion: January 2012
Last Updated: February 22, 2011
Last Verified: February 2011
