Sildenafil and Uteroplacental Perfusion
Recruitment status was: Recruiting
Fetal Growth Retardation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil|
- Uteroplacental Perfusion [ Time Frame: 2 hours after sildenafil ingestion ] [ Designated as safety issue: Yes ]
- fetal growth [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]
- umbilical artery blood gass assessment [ Time Frame: immediately after birth ] [ Designated as safety issue: Yes ]
- effect on fetal well being [ Time Frame: 2 hours after sildenafil ] [ Designated as safety issue: No ]when BP score is<8 we repeat it after sildenafil ingestion
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
50 mg TDS orally until birth
Other Name: viagra
|Placebo Comparator: Placebo control||
Other Name: placebo tid
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 .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107782
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||marzieh vahid dastjerdi, M.D.||Iranian's ministery of health|
|Study Director:||Sayedeh Afagh Hosseini, MD.||resident of OB&GYN|