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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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sildenafil citrate | Experimental | 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. |
|
| low molecular weight heparin | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal birth weight in grams | At time of Delivery |
| 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, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radwa R Ali, MD | Contact | 01283492979 | +202 | radwaebed@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AinShams university maternity hospital | Recruiting | Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D006495 | Heparin, Low-Molecular-Weight |
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| low molecular weight heparin | Drug | a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till 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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |