Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Phase 3

• Conditions: Fetal Growth Restriction
• Interventions: Drug: Placebo Oral Tablet; Drug: Sildenafil Citrate 25Mg Tab

• Registration Number: NCT03177824
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-30
• Study First Submitted: 2017-04-26
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09
• Primary Completion: 2017-09-30
• Study Completion: 2017-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Maternal age ranging from 20-40 years.
• Gestational age 28-37 weeks.

Exclusion Criteria

• Obese patients (BMI >30 kg/m2).
• Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
• Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
• Fetal distress.
• Pregnancy of multiple fetuses.
• Congenital fetal malformation or chromosomal abnormalities.
• Diastolic blood pressure more than 110 mmHg.
• Hypersensitivity to the drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	Placebo Oral Tablet	placebo oral tablet
S	Sildenafil Citrate 25Mg Tab	Sildenafil citrate (25mg)

Primary Outcome Measures

Name	Time	Method
date of delivery after Sildenafil citrate administration.	for 6 months from the beginning of the study	the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.

Secondary Outcome Measures

Name	Time	Method
neonatal outcomes as regard birth weight	for 6 months from the beginning of the study	the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Expected fetal weight by serial ultrasound after Sildenafil citrate administration	every two weeks after drug intake for 6 months from the beginning of the study	the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Color Doppler changes on umbilical artery	weekly after drug intake for 6 months from the beginning of the study	Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
neonatal outcomes as regard APGAR score	for 6 months from the beginning of the study	the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.

Trial Locations

Locations (1)

Ain Shams matrnity hospital; 🇪🇬 Cairo, Egypt