Sildenafil Citrate for Treatment of Growth-restricted Fetuses

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

Study Overview

• Status: Unknown
• Conditions: Fetal Growth Restriction
• Intervention / Treatment: Drug: Sildenafil Citrate 25Mg Tab; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: shaimaa mohamed Ezz el Din, MB ChB; Phone Number: +201000484298; Email: dr.shaimaaezz666@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams matrnity hospital
    • Contact: shaimaa mohamed Ezz el Din, MB ChB; Phone Number: +201000484298; Email: dr.shaimaaezz666@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S; Sildenafil citrate (25mg)	Drug: Sildenafil Citrate 25Mg Tab; Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
Placebo Comparator: P; placebo oral tablet	Drug: Placebo Oral Tablet; Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
date of delivery after Sildenafil citrate administration.	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.	for 6 months from the beginning of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expected fetal weight by serial ultrasound after Sildenafil citrate administration	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 .	every two weeks after drug intake for 6 months from the beginning of the study
Color Doppler changes on umbilical artery	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 .	weekly after drug intake for 6 months from the beginning of the study
neonatal outcomes as regard birth weight	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.	for 6 months from the beginning of the study
neonatal outcomes as regard APGAR score	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.	for 6 months from the beginning of the study

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Anticipated): September 30, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• 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: 123sc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No