Status:
UNKNOWN
Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
Lead Sponsor:
Ain Shams University
Conditions:
Fetal Growth Abnormality
Fetal Growth Restriction
Eligibility:
FEMALE
20-35 years
Phase:
PHASE3
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03230162
Start Date
June 1 2017
End Date
May 1 2018
Last Update
July 26 2017
Active Locations (1)
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1
AinShams university maternity hospital
Cairo, Egypt, 02