Sildenafil and Uteroplacental Perfusion

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Fetal Growth Retardation

Treatments: Drug: sildenafil; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01107782

87-821

Details and patient eligibility

About

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

Full 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 .

Enrollment: 70 estimated patients

Sex: Female

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

sildenafil

Experimental group

Treatment:

Drug: sildenafil

Placebo control

Placebo Comparator group

Treatment:

Drug: placebo