Fetal Growth Abnormality, Fetal Growth Restriction
Conditions
Brief summary
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency
Detailed description
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)
Interventions
DRUGSildenafil
sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
DRUGlow molecular weight heparin
a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal birth weight in grams | At time of Delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the interval between the diagnosis and delivery | at time of delivery | — |
| The change in Doppler velocity indices, | 24 week till 35 weeks | — |
| Fetal growth velocity | weekly till time of delivery | — |
| Neonatal ICU admission rate | The first 28 day of delivery | — |
| APGAR score | at 1 and 5 min of life | — |
| Neonatal complication rates | The first 28 day of delivery | respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion |
| Gestational age at delivery, | at time of delivery | — |
Countries
Egypt
Contacts
Primary ContactRadwa R Ali, MD
Outcome results
None listed