Fetal Growth Retardation
Conditions
Keywords
sildenafil, FGR
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 .
Interventions
DRUGsildenafil
50 mg TDS orally until birth
DRUGplacebo
50mg tid
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uteroplacental Perfusion | 2 hours after sildenafil ingestion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fetal growth | after 6 months | — |
| umbilical artery blood gass assessment | immediately after birth | — |
| effect on fetal well being | 2 hours after sildenafil | when BP score is\<8 we repeat it after sildenafil ingestion |
Countries
Iran
Contacts
Primary Contactsayedeh afagh hosseini, M.D.
Outcome results
None listed