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Sildenafil and Uteroplacental Perfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Fetal Growth Retardation Drug: sildenafil Drug: placebo Phase 2 Phase 3

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 .


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Uteroplacental Perfusion [ Time Frame: 2 hours after sildenafil ingestion ]

Secondary Outcome Measures :
  1. fetal growth [ Time Frame: after 6 months ]
  2. umbilical artery blood gass assessment [ Time Frame: immediately after birth ]
  3. effect on fetal well being [ Time Frame: 2 hours after sildenafil ]
    when BP score is<8 we repeat it after sildenafil ingestion


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

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


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

Responsible Party: Marzieh Vahid Dastjerdi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01107782     History of Changes
Other Study ID Numbers: 87-821
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

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 Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents