JAMA

Intrapartum sildenafil fails to improve fetal outcomes in randomized trial

June 16, 2025

Intrapartum sildenafil didn't improve perinatal outcomes and shouldn't be used for fetal hypoxia prevention during labor. These findings highlight the importance of evidence-based evaluation before introducing pharmacologic interventions in obstetric care.

Study details: This multicenter, placebo-controlled randomized trial enrolled 3,257 women at 13 Australian hospitals between September 2021 and June 2024. Participants were at term with singleton or dichorionic twin pregnancies and planned vaginal births. They were randomized to receive oral sildenafil citrate (50 mg every 8 hours, up to 150 mg) or placebo during labor. The primary outcome was a composite of adverse perinatal events related to intrapartum hypoxia.

Results: The primary outcome occurred in 5.1% of the sildenafil group and 5.2% of the placebo group (relative risk [RR], 1.02; 95% confidence interval [CI], 0.75–1.37), showing no significant difference. Secondary outcomes, including emergency cesarean or instrumental delivery for fetal distress, also showed no benefit (RR, 1.12; 95% CI, 0.98–1.29). Subgroup analyses revealed no heterogeneity in treatment effect.

Source:

Kumar S; iSEARCH Investigators, et al. (2025, June 9). JAMA. Intrapartum Sildenafil to Improve Perinatal Outcomes: A Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40489090/