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

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Fetal Growth Retardation

Treatments: Drug: placebo; Drug: Sildenafil citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02590536

SFGR

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

sildenafil citrate

Experimental group

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

Treatment:

Drug: Sildenafil citrate

placebo

Placebo Comparator group

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.

Treatment:

Drug: placebo