NCT03153215

Sildenafil in Sever Intrauterine Growth Retardation

Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.

Detailed description

The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardation.A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study . Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil citrate therapy may increase the likelihood of increased growth velocity \[measured by abdominal circumference (AC) (ultrasound)\] for fetuses of pregnancies complicated by severe early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease, consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental abruption and has been implicated in more than 50% of iatrogenic premature births .For this reason, the problem of severe FGR forms a substantial portion of the population that tertiary care centres care.

Conditions

• Intra-Uterine Growth Retardation

Interventions

Type	Name	Description
OTHER	treatment	We will offer Sildenafil citrate (20 mg per os three times daily until delivery) as innovative therapy to 23 women with severe IUGR ('Sildenafil-treated') in addition to fish oil and zinc supplementation.
OTHER	Placebo	Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.

Timeline

• Start date: 2017-05-06
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2017-05-15
• Last updated: 2018-07-10

Locations

1 site across 1 country: Egypt