Fetal Growth Restriction Clinical Trial
Official title:
Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 1, 2018 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | AinShams university maternity hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal birth weight in grams | At time of Delivery | ||
Secondary | The change in Doppler velocity indices, | 24 week till 35 weeks | ||
Secondary | Fetal growth velocity | weekly till time of delivery | ||
Secondary | Gestational age at delivery, | at time of delivery | ||
Secondary | APGAR score | at 1 and 5 min of life | ||
Secondary | 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 | |
Secondary | Neonatal ICU admission rate | The first 28 day of delivery | ||
Secondary | the interval between the diagnosis and delivery | at time of delivery |
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