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

Primary Purpose

Fetal Growth Retardation

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil citrate
placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Growth Retardation focused on measuring Sildenafil, Fetal growth Restriction, Umbilical Artery Doppler

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ain shams university maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sildenafil citrate

placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI) of the umbilical arteries as a Ratio
The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI), of fetal middle cerebral artery as a Ratio

Secondary Outcome Measures

Neonatal birth weight in grams
Gestational age at delivery in weeks
Neonatal complication rates including Intraventricular hemorrhage (IVH) , Neonatal Necrotizing Enterocolitis (NEC) , Syndrome Respiratory Distress (RDS) , Neonatal anemia, Neonatal blood transfusion).
Neonatal ICU admission rate

Full Information

First Posted
October 21, 2015
Last Updated
August 13, 2017
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02590536
Brief Title
A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
Official Title
A Randomized Controlled Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation
Keywords
Sildenafil, Fetal growth Restriction, Umbilical Artery Doppler

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sildenafil citrate
Arm Type
Experimental
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI) of the umbilical arteries as a Ratio
Time Frame
24 weeks to 34 weeks of gestation.
Title
The change in Doppler velocity indices( Resistance index (RI) and the pulsatility index (PI), of fetal middle cerebral artery as a Ratio
Time Frame
24 weeks to 34 weeks of gestation.
Secondary Outcome Measure Information:
Title
Neonatal birth weight in grams
Time Frame
At time of Delivery
Title
Gestational age at delivery in weeks
Time Frame
At time of Delivery
Title
Neonatal complication rates including Intraventricular hemorrhage (IVH) , Neonatal Necrotizing Enterocolitis (NEC) , Syndrome Respiratory Distress (RDS) , Neonatal anemia, Neonatal blood transfusion).
Time Frame
The first 28 day of delivery
Title
Neonatal ICU admission rate
Time Frame
The first 28 day of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled I Abdullah, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherif A Ashoush, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heba E Hosney, MSc
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain shams university maternity hospital
City
Cairo
ZIP/Postal Code
25187
Country
Egypt

12. IPD Sharing Statement

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

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