A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction

Conditions
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Fetal Growth Retardation

Intervention / Treatment
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* Drug: Sildenafil citrate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sildenafil citrate<br>Group A (45 patients): pregnancies affected by Fetal Growth Restriction (FGR) being treated with sildenafil citrate 25 mg of sildenafil citrate every 8 hours starting at diagnosis of FGR until delivery | Drug: Sildenafil citrate<br>* 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.<br>|
| Placebo Comparator: placebo<br>Group B (45 patients): pregnancies affected by Fetal Growth Restriction (FGR) being treated with placebo every 8 hours starting at diagnosis of FGR until delivery. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sildenafil, Fetal growth Restriction, Umbilical Artery Doppler