Fetal Growth Retardation
Conditions
Keywords
Sildenafil, Fetal growth Restriction, Umbilical Artery Doppler
Brief summary
This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler velocity indices of the umbilical arteries in patients with placental insufficiency and fetal growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those patients.
Interventions
DRUGSildenafil citrate
In patients with Fetal Growth Restriction (FGR)and abnormal umbilical artery Doppler, will be randomly assigned and divided to 2 groups which will be treated with sildenafil citrate either placebo. This study will compare the change in Resistance Index (RI) and the Pulsatility Index (PI) of the umbilical artery and fetal middle cerebral artery, for patients who receive 25 mg of oral sildenafil citrate 8 hourly starting at diagnosis of FGR until delivery against those who will receive placebo of the same color and shape of sildenafil citrate tablet.
DRUGplacebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women, singleton pregnancy, gestational age 24-34 weeks, with * Fetal growth restriction. * Intact membranes. * Abnormal umbilical artery Doppler waveforms. * Fetal abdominal circumference at or below the tenth percentile. * Normal venous fetal Doppler
Exclusion criteria
* Undetermined gestational age. * Intrauterine infection. * High Risk for aneuploidy (e.g. maternal age ≥40 years, detected congenital fetal anomalies in the current or previous pregnancies). * Maternal cardiovascular morbidity. * Users of any vasodilator agents. * Known allergy to sildenafil citrate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI) of the umbilical arteries as a Ratio | 24 weeks to 34 weeks of gestation. |
| The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI), of fetal middle cerebral artery as a Ratio | 24 weeks to 34 weeks of gestation. |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal birth weight in grams | At time of Delivery |
| Gestational age at delivery in weeks | At time of Delivery |
| Neonatal complication rates including Intraventricular hemorrhage (IVH) , Neonatal Necrotizing Enterocolitis (NEC) , Syndrome Respiratory Distress (RDS) , Neonatal anemia, Neonatal blood transfusion). | The first 28 day of delivery |
| Neonatal ICU admission rate | The first 28 day of delivery |
Countries
Egypt
Outcome results
None listed