comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency
One hundred pregnant women with documented intrauterine growth restriction due to placental insufficiency at 28-35 weeks of gestation will be distributed into two groups: * Group S: 50 women will receive Sildenafil citrate 25 mg tab 3 times daily. * Group H: 50 women will receive single dose of LMWH subcutaneous daily. Both groups will undergo strict fetal surveillance in the form of: Umbilical artery Doppler (UAD) is the primary surveillance tool in the FGR fetus: middle cerebral artery (MCA) Doppler, ultrasound for (AC, EFW, and deepest vertical pocket (DVP) for amniotic fluid) and non stress test and Biophysical profile (BPP)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
AinShams university maternity hospital
Cairo, Egypt
RECRUITINGNeonatal birth weight in grams
Time frame: At time of Delivery
The change in Doppler velocity indices,
Time frame: 24 week till 35 weeks
Fetal growth velocity
Time frame: weekly till time of delivery
Gestational age at delivery,
Time frame: at time of delivery
APGAR score
Time frame: at 1 and 5 min of life
Neonatal complication rates
respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion
Time frame: The first 28 day of delivery
Neonatal ICU admission rate
Time frame: The first 28 day of delivery
the interval between the diagnosis and delivery
Time frame: at time of delivery
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