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

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

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.

Study Overview

• Status: Completed
• Conditions: Fetal Growth Retardation
• Intervention / Treatment: Drug: placebo; Drug: Sildenafil citrate

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 25187
    • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sildenafil citrate; 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; 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.
Placebo Comparator: placebo; 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Neonatal birth weight in grams	At time of Delivery
Neonatal ICU admission rate	The first 28 day 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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Khaled I Abdullah, MD, Ain Shams University; Principal Investigator: Sherif A Ashoush, MD, Ain Shams University; Principal Investigator: Heba E Hosney, MSc, Ain Shams University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 2, 2017

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 13, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Sildenafil; Fetal growth Restriction; Umbilical Artery Doppler
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: SFGR