Clinical Trial: A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Randomized Controlled Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
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.
Detailed Summary:
Sponsor: Ain Shams University
Current Primary Outcome: The change in Doppler velocity indices, Resistance index (RI) and the pulsatility index (PI), of the umbilical arteries and fetal middle cerebral artery as a Ratio [ Time Frame: 24 weeks to 34 weeks of gestation. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Neonatal birth weight in grams [ Time Frame: At time of Delivery ]
- Gestational age at delivery in weeks [ Time Frame: At time of Delivery ]
- Neonatal complication rates including Intraventricular hemorrhage (IVH) , Neonatal Necrotizing Enterocolitis (NEC) , Syndrome Respiratory Distress (RDS) , Neonatal anemia, Neonatal blood transfusion). [ Time Frame: The first 28 day of delivery ]
- Neonatal ICU admission rate [ Time Frame: The first 28 day of delivery ]
Original Secondary Outcome: Same as current
Information By: Ain Shams University
Dates:
Date Received: October 21, 2015
Date Started: October 2015
Date Completion:
Last Updated: October 28, 2015
Last Verified: October 2015
