Sildenafil and Uteroplacental Perfusion
- Registration Number
- NCT01107782
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief 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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 70
- FGR pregnancies in 24-37 weeks of GA
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sildenafil sildenafil - Placebo control placebo -
- Primary Outcome Measures
Name Time Method Uteroplacental Perfusion 2 hours after sildenafil ingestion
- Secondary Outcome Measures
Name Time Method fetal growth after 6 months umbilical artery blood gass assessment immediately after birth effect on fetal well being 2 hours after sildenafil when BP score is\<8 we repeat it after sildenafil ingestion
Trial Locations
- Locations (1)
Tehran UMS
🇮🇷Tehran, Iran, Islamic Republic of