Trial | NCT01107782  Report issue

Title

Sildenafil and Uteroplacental Perfusion
Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    sildenafil ...

  • Study Participants

    70
The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.
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 .
Study Started
Jun 30
2008
Primary Completion
Jun 30
2010
Anticipated
Study Completion
Jan 31
2012
Anticipated
Last Update
Feb 23
2011
Estimate

Drug sildenafil

50 mg TDS orally until birth

  • Other names: viagra

Drug placebo

50mg tid

  • Other names: placebo tid

sildenafil Experimental

Placebo control Placebo Comparator

Criteria 

Inclusion Criteria:

FGR pregnancies in 24-37 weeks of GA

Exclusion Criteria:

vasodilator agents usage
history of cardiovascular morbidity specially of right heart side
drug or alcohol abusers
systolic BP more than 210 mm Hg or diastolic BP more than 120 mm Hg
No Results Posted