Sildenafil Citrate for Treatment of Growth-restricted Fetuses

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Fetal Growth Restriction

Treatments: Drug: Placebo Oral Tablet; Drug: Sildenafil Citrate 25Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT03177824

123sc

Details and patient eligibility

About

The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Maternal age ranging from 20-40 years.
• Gestational age 28-37 weeks.

Exclusion criteria

• Obese patients (BMI >30 kg/m2).
• Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
• Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
• Fetal distress.
• Pregnancy of multiple fetuses.
• Congenital fetal malformation or chromosomal abnormalities.
• Diastolic blood pressure more than 110 mmHg.
• Hypersensitivity to the drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

S

Experimental group

Description:

Sildenafil citrate (25mg)

Treatment:

Drug: Sildenafil Citrate 25Mg Tab

P

Placebo Comparator group

Description:

placebo oral tablet

Treatment:

Drug: Placebo Oral Tablet