Sildenafil and Uteroplacental Perfusion

February 22, 2011 updated by: Tehran University of Medical Sciences

Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Tehran UMS
        • Contact:
        • Principal Investigator:
          • Marzieh Vahid Dastjerdi, MD.
        • Principal Investigator:
          • Sayedeh Afagh Hosseini, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control
Drug: placebo
50mg tid
Other Names:
  • placebo tid
Experimental: sildenafil
Drug: sildenafil
50 mg TDS orally until birth
Other Names:
  • viagra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Uteroplacental Perfusion
Time Frame: 2 hours after sildenafil ingestion
2 hours after sildenafil ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetal growth
Time Frame: after 6 months
after 6 months
umbilical artery blood gass assessment
Time Frame: immediately after birth
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
2 hours after sildenafil

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87-821

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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