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

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ClinicalTrials.gov Identifier: NCT02590536
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdel Shafy El Shahawy, 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.

Condition or disease Intervention/treatment Phase
Fetal Growth Retardation Drug: Sildenafil citrate Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
Study Start Date : October 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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 Comparator: 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.
Drug: placebo



Primary Outcome Measures :
  1. 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. ]
  2. 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 Measures :
  1. Neonatal birth weight in grams [ Time Frame: At time of Delivery ]
  2. Gestational age at delivery in weeks [ Time Frame: At time of Delivery ]
  3. 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 ]
  4. Neonatal ICU admission rate [ Time Frame: The first 28 day of delivery ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590536


Locations
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Egypt
Ain shams university maternity hospital
Cairo, Egypt, 25187
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Khaled I Abdullah, MD Ain Shams University
Principal Investigator: Sherif A Ashoush, MD Ain Shams University
Principal Investigator: Heba E Hosney, MSc Ain Shams University
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Responsible Party: Ahmed Abdel Shafy El Shahawy, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT02590536    
Other Study ID Numbers: SFGR
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Keywords provided by Ahmed Abdel Shafy El Shahawy, Ain Shams University:
Sildenafil
Fetal growth Restriction
Umbilical Artery Doppler
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents