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

Phase 3

Completed

• Conditions: Fetal Growth Retardation
• Interventions: Drug: Sildenafil citrate; Drug: placebo

• Registration Number: NCT02590536
• Lead Sponsor: Ain Shams University

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 Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Primary Completion: 2017-06
• Study Completion: 2017-06-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-13
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sildenafil citrate	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
placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Neonatal birth weight in grams	At time of Delivery
Gestational age at delivery in weeks	At time of Delivery

Trial Locations

Locations (1)

Ain shams university maternity hospital; 🇪🇬 Cairo, Egypt