Evidence Hub

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

M. Ghaleb, Youssef Labib, K. Wahba

2021

200 participants · 1 citation

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.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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