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

Fetal Growth Retardation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590536
• Other study ID #: SFGR
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2015
• Last updated: August 13, 2017
• Start date: October 2015
• Est. completion date: June 2, 2017

Study information

• Verified date: August 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain shams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Neonatal birth weight in grams		At time of Delivery
Secondary	Gestational age at delivery in weeks		At time of Delivery
Secondary	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
Secondary	Neonatal ICU admission rate		The first 28 day of delivery