Beni-Suef University
Cairo, Beni Suweif Governorate, 12412, Egypt
NCT Number: NCT03153215
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.
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Notify Me25 year–40 year
Female
Interventional
Not applicable
Cairo, Beni Suweif Governorate, 12412, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.
Time frame: between 24 gestational weeks until 36 weeks
Change in umbilical artery pulsatility index after medication
Time frame: between 24 gestational weeks until 36 weeks
Change in middle cerebral artery pulsatility index after medication
Time frame: between 24 gestational weeks until 36 weeks
proportion of women in each group for whom fetal AC growth velocity will change post randomization.
Time frame: between 24 and 36 gestational weeks
Women in the Sildenafil-treated group will be also monitored for adverse side-effects, such as flushing, lightheadedness and visual disturbance
Time frame: between 24 and 36 gestational weeks
weight of neonate at birth in grams
Beni-Suef University
Other
Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction
Acronym: IUGR
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