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

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Citric Acid; Sildenafil Citrate

Criteria

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