Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

Study Overview
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Brief Summary
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comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency

Detailed Description
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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)

Official Title
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Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

Conditions
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Fetal Growth Abnormality, Fetal Growth Restriction

Intervention / Treatment
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* Drug: Sildenafil
* Drug: low molecular weight heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal age between 20-35 years. Being at a gestational age 28-35wks. Singleton pregnancy. Fetal growth restriction diagnosed by ultrasound with estimated fetal weight below the 10th percentile, and/or fetal abdominal circumference at or below the tenth percentile. Exclusion Criteria: Maternal age less than 20 years or more than 35 years. Undetermined gestational age. Multiple gestation. Chronic diseases with pregnancy e.g. Chronic hypertension, diabetes type 1 or 2. Etiologies of FGR other than placental insufficiency as fetal malformations, aneuploidy or infections. Suspected fetal compromise requiring emergency delivery. Any contraindication to the use of sildenafil e.g. known significant maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil. Any contraindication to the use of LMWH e.g. known bleeding disorder, active antenatal bleeding or at increased risk of major hemorrhage (e.g. placenta praevia), thrombocytopenia, severe renal or hepatic disease. Drug or alcohol abuse. Patient refusing to participate in the study or unable to consent.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sildenafil citrate<br>50 pregnant female will be treated with sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery. | Drug: Sildenafil<br>* sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery<br>* Other names: Silden EIPICO co.;|
| Experimental: low molecular weight heparin<br>50 pregnant female will be treated with a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery according to body weight as follow < 50 kg 3500 units daily 50-90 kg 4500 units daily 91-130 kg 7000 units daily 131-170 kg 9000 units daily > 170 kg 75 u/kg/day | Drug: low molecular weight heparin<br>* a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery<br>* Other names: Innohep LEO pharmaceutical products;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal birth weight in grams |  | At time of Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Doppler velocity indices, |  | 24 week till 35 weeks | 
| Fetal growth velocity |  | weekly till time of delivery | 
| Gestational age at delivery, |  | at time of delivery | 
| APGAR score |  | 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 | The first 28 day of delivery | 
| Neonatal ICU admission rate |  | The first 28 day of delivery | 
| the interval between the diagnosis and delivery |  | at time of delivery |