NCT02590536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

October 21, 2015

Last Update Submit

August 13, 2017

Conditions

Fetal Growth Retardation

Keywords

SildenafilFetal growth RestrictionUmbilical Artery Doppler

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • Neonatal birth weight in grams

    At time of Delivery

  • Gestational age at delivery in weeks

    At time of Delivery

  • 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

  • Neonatal ICU admission rate

    The first 28 day of delivery

Study Arms (2)

sildenafil citrate

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Sildenafil citrateDRUG

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.

sildenafil citrate
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university maternity hospital

Cairo, 25187, Egypt

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Khaled I Abdullah, MD

    Ain Shams University

    STUDY CHAIR

  • Sherif A Ashoush, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Heba E Hosney, MSc

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 29, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 2, 2017

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

EG(1)