Sildenafil and Uteroplacental Perfusion
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|ClinicalTrials.gov Identifier: NCT01107782|
Recruitment Status : Unknown
Verified February 2011 by Tehran University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : April 21, 2010
Last Update Posted : February 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fetal Growth Retardation||Drug: sildenafil Drug: placebo||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||January 2012|
50 mg TDS orally until birth
Other Name: viagra
|Placebo Comparator: Placebo control||
Other Name: placebo tid
- Uteroplacental Perfusion [ Time Frame: 2 hours after sildenafil ingestion ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107782
|Contact: sayedeh afagh hosseini, M.D.||+firstname.lastname@example.org|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Contact: sayedeh afagh hosseini, M.D. +989188111670 email@example.com|
|Principal Investigator: Marzieh Vahid Dastjerdi, MD.|
|Principal Investigator: Sayedeh Afagh Hosseini, MD.|
|Study Chair:||marzieh vahid dastjerdi, M.D.||Iranian's ministery of health|
|Study Director:||Sayedeh Afagh Hosseini, MD.||resident of OB&GYN|