search
Back to results

Sildenafil and Uteroplacental Perfusion

Primary Purpose

Fetal Growth Retardation

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
sildenafil
placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Growth Retardation focused on measuring sildenafil, FGR

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tehran UMSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sildenafil

Placebo control

Arm Description

Outcomes

Primary Outcome Measures

Uteroplacental Perfusion

Secondary Outcome Measures

fetal growth
umbilical artery blood gass assessment
effect on fetal well being
when BP score is<8 we repeat it after sildenafil ingestion

Full Information

First Posted
January 13, 2010
Last Updated
February 22, 2011
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01107782
Brief Title
Sildenafil and Uteroplacental Perfusion
Official Title
Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation
Keywords
sildenafil, FGR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sildenafil
Arm Type
Experimental
Arm Title
Placebo control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
sildenafil
Other Intervention Name(s)
viagra
Intervention Description
50 mg TDS orally until birth
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo tid
Intervention Description
50mg tid
Primary Outcome Measure Information:
Title
Uteroplacental Perfusion
Time Frame
2 hours after sildenafil ingestion
Secondary Outcome Measure Information:
Title
fetal growth
Time Frame
after 6 months
Title
umbilical artery blood gass assessment
Time Frame
immediately after birth
Title
effect on fetal well being
Description
when BP score is<8 we repeat it after sildenafil ingestion
Time Frame
2 hours after sildenafil

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sayedeh afagh hosseini, M.D.
Phone
+989188111670
Email
afahoss@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marzieh vahid dastjerdi, M.D.
Organizational Affiliation
Iranian's ministery of health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sayedeh Afagh Hosseini, MD.
Organizational Affiliation
resident of OB&GYN
Official's Role
Study Director
Facility Information:
Facility Name
Tehran UMS
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sayedeh afagh hosseini, M.D.
Phone
+989188111670
Email
afahoss@yahoo.com
First Name & Middle Initial & Last Name & Degree
Marzieh Vahid Dastjerdi, MD.
First Name & Middle Initial & Last Name & Degree
Sayedeh Afagh Hosseini, MD.

12. IPD Sharing Statement

Learn more about this trial

Sildenafil and Uteroplacental Perfusion

We'll reach out to this number within 24 hrs