The effect of sildenafil on maternal mortality and fetal adverse outcomes among pregnant patients with congenital heart disease-associated pulmonary artery hypertension: A retrospective cohort study
Abstract
Background and aim: Maternal and fetal mortality in patients with congenital heart disease-associated pulmonary artery hypertension (CHD-PAH) is reported to be quite high. Sildenafil is the standard of care in PAH. Studies on sildenafil in maternal and fetal clinical outcomes are few. This study aimed to determine the effect of oral sildenafil on the clinical outcomes of mothers and fetuses with CHD-PAH.
Methods: This study was an observational study with a retrospective cohort method. Patient data were taken from the hospital registry and medical records of patients who met the research criteria from August 2015 to August 2022. Based on sildenafil treatment, subjects were divided into two groups: subjects with oral sildenafil and those without sildenafil. The research outcome was maternal mortality and a composite of fetal adverse outcomes, defined as fetal mortality, oligohydramnios, intrauterine growth retardation (IUGR), and small for gestational age.
Results: There were 68 pregnant women who met research criteria, consisting of subjects with sildenafil (n = 32) and without sildenafil (n = 36). A composite of maternal and fetal adverse outcomes occurred in 24 subjects (35.3%). Subjects with oral sildenafil therapy were not associated with maternal mortality. Subjects with oral sildenafil therapy had a lower incidence of fetal adverse outcomes (n = 7, 21.9%) as compared to those without sildenafil (n = 25, 56.8%), P = 0.029. In the multivariate analysis, oral sildenafil…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 68 participants or records.
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