Sildenafil Citrate versus Aspirin/Heparin Combination for Fetal Growth Restriction: A Randomized Clinical Trial
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- Category: Vol. 85, December 2017
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Sildenafil Citrate versus Aspirin/Heparin Combination for Fetal Growth Restriction: A Randomized Clinical Trial, HEND A. SHALABY
Abstract
Objective: To investigate the effectiveness of Sildenafil vs Heparin/Aspirin combination in pregnancies complicated by IUGR.
Subjects and Mothods: The study was conducted at Man-soura University Hospitals, Mansoura, Egypt December 2015 to November 2016. One hundred patients (50 in each arm of the study), who had proven intrauterine growth restriction, were selected and enrolled into a randomized clinical trial. Patients were allocated into two groups using computer-generated tables; Group A n=40: Received Sildenafil citrate orally 20mg every 8 hours from inclusion till delivery and the dose was adjusted according to maternal perception of side effects. Group B n=43: Received prophylactic dose of low molecular weight Heparin 40mg/day (Clexane 40mg) as subcutaneous injection once daily plus low dose Aspirin 75mg orally once daily also from the time of inclusion till delivery. Cases were subjected to fetal and maternal surveillance and the frequency was depending on the result of preliminary assessment.
Results: Patients' age, parity, BMI, gestational age and other demographic data were similar in both groups, p>0.05. Sildenafil treatment group show significant increase in AC and EFW (188.7mm vs 206.8mm and 926gm vs 1105gm respectively p=0.001). Also there was significant increase in AFI and umbilical artery Doppler parameters. Group 2 (heparin/aspirin) also show significant improvement in fetal biometry and Doppler parameters but when comparing the differences between the two groups, none of these changes were statistically significant. The time between enrolment in the study and delivery was significantly longer in heparin group (25.4 days vs 21.7 days p=0.04) and the sildenafil group experienced significant side effects (13 cases vs none).
Conclusion: From the results of our study we concluded that sildenafil alone or heparin and aspirin combination has beneficial effects in the treatment strategy of growth restricted fetuses with improvement of fetal growth parameters and reduction of NICU admissions, none of the treatment options is found superior to the other.