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

NCT ID: NCT02590536

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-06-02

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.

Conditions

Fetal Growth Retardation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Sildenafil citrate

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdel Shafy El Shahawy

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled I Abdullah, MD

Role: STUDY_CHAIR

Ain Shams University

Sherif A Ashoush, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Heba E Hosney, MSc

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain shams university maternity hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

SFGR

Identifier Type: -

Identifier Source: org_study_id