Sildenafil plus Low Dose Aspirin for Prevention of Preeclampsia: A Randomized Controlled Trial

Abstract

Objective: To compare between the efficacy of the use of oral sildenafil plus low dose aspirin versus the use of oral low dose aspirin alone in pregnancy as preventive measure in women at risk for preeclampsia (PE). Design: A randomized clinical trial. Setting: Outpatient Obstetric clinic of Ain Shams University Maternity Hospital. Population or sample: Women at gestational age of ≤16 weeks who at risk for PE between June 2018 and June 2019. Methods: Participants were randomly allocated into two groups: Group I Included 200 women who received a 25 mg tablet of oral sildenafil citrate tid until delivery plus 100 mg tablet of aspirin orally once daily until gestational age of 36 weeks, Group II Included 200 women who received a 100 mg tablet of aspirin orally once daily until gestational age of 36 weeks. Main Outcome Measures: Incidence of preeclampsia diagnosed per ACOG criteria. Results: The incidence of PE in both groups showed no statistically significant difference. The incidence of PE in the first group is 11.0%, and it is 12.0% in the second group (p-value 0.754). Conclusion: The addition of sildenafil citrate to low dose aspirin had no impact on the prevention of preeclampsia for women at risk of PE, in addition, sildenafil did not improve maternal and fetal outcomes.