The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score
Ain Shams matrnity hospital
Cairo, Egypt
RECRUITINGdate of delivery after Sildenafil citrate administration.
the study aims to assess date of delivery of growth restricted fetus after administration of sildenafil citrate by dose of 20mg three times per day , and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Time frame: for 6 months from the beginning of the study
Expected fetal weight by serial ultrasound after Sildenafil citrate administration
the Expected fetal weight in grams by serial ultrasound is assessed in women with growth redistricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Time frame: every two weeks after drug intake for 6 months from the beginning of the study
Color Doppler changes on umbilical artery
Color Doppler changes on umbilical artery is assessed in women with growth restricted fetuses in Ain shams university maternity hospital after Sildenafil citrate administration and till time of delivery .
Time frame: weekly after drug intake for 6 months from the beginning of the study
neonatal outcomes as regard birth weight
the study aims to assess neonatal outcomes as regard, birth weight in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
Time frame: for 6 months from the beginning of the study
neonatal outcomes as regard APGAR score
the study aims to assess neonatal outcomes as regard APGAR score in growth restricted fetus after administration of sildenafil citrate and that will be done by following up women with growth redistricted fetuses in Ain shams university maternity hospital till time of delivery.
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Time frame: for 6 months from the beginning of the study