Sildenafil and Uteroplacental Perfusion

Fetal Growth Retardation Clinical Trial

Official title:

Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01107782
• Other study ID #: 87-821
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 13, 2010
• Last updated: February 22, 2011
• Start date: June 2008
• Est. completion date: January 2012

Study information

• Verified date: February 2011
• Source: Tehran University of Medical Sciences
• Contact: sayedeh afagh hosseini, M.D.
• Phone: +989188111670
• Email: afahoss[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

Drug:
• sildenafil
50 mg TDS orally until birth
• placebo
50mg tid

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran UMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uteroplacental Perfusion		2 hours after sildenafil ingestion	Yes
Secondary	fetal growth		after 6 months	Yes
Secondary	umbilical artery blood gass assessment		immediately after birth	Yes
Secondary	effect on fetal well being	when BP score is<8 we repeat it after sildenafil ingestion	2 hours after sildenafil	No