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Sildenafil and Uteroplacental Perfusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01107782
First received: January 13, 2010
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.


Condition Intervention Phase
Fetal Growth Retardation
 Drug: sildenafil
Drug: placebo
 Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Uteroplacental Perfusion [ Time Frame: 2 hours after sildenafil ingestion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
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)
Arms Assigned Interventions
Experimental: sildenafil Drug: sildenafil
50 mg TDS orally until birth
Other Name: viagra
Placebo Comparator: Placebo control Drug: placebo
50mg tid
Other Name: placebo tid

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 .

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107782

Contacts
Contact: sayedeh afagh hosseini, M.D. +989188111670 afahoss@yahoo.com

Locations
Iran, Islamic Republic of
Tehran UMS Recruiting
Tehran, Iran, Islamic Republic of
Contact: sayedeh afagh hosseini, M.D.     +989188111670     afahoss@yahoo.com    
Principal Investigator: Marzieh Vahid Dastjerdi, MD.            
Principal Investigator: Sayedeh Afagh Hosseini, MD.            
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: marzieh vahid dastjerdi, M.D. Iranian's ministery of health
Study Director: Sayedeh Afagh Hosseini, MD. resident of OB&GYN
  More Information

No publications provided

Responsible Party: Marzieh Vahid Dastjerdi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01107782     History of Changes
Other Study ID Numbers: 87-821
Study First Received: January 13, 2010
Last Updated: February 22, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
sildenafil
FGR

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013