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NCT Number: NCT02590536

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

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.

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Key information

Conditions

Fetal Growth Retardation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ain shams university maternity hospital

Cairo, 25187, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sildenafil citrate

Drug

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

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2015
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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