Intrapartum Sildenafil to Improve Perinatal Outcomes: A Randomized Clinical Trial
Abstract
Importance
Sildenafil citrate may increase uteroplacental blood flow. Its ability to reduce perinatal complications related to fetal hypoxia during labor is uncertain.
Objective
To compare the effectiveness of intrapartum maternal oral sildenafil citrate vs placebo in improving perinatal outcomes potentially related to intrapartum hypoxia in term pregnancies.
Design, Setting, and Participants
This pragmatic, multicenter, investigator-initiated, placebo-controlled randomized clinical trial including 3257 women was conducted in 13 Australian hospitals from September 6, 2021, to June 28, 2024. The last date of follow-up (28-day neonatal mortality) was July 26, 2024. Women aged 18 years or older with singleton or dichorionic twin pregnancies, planning vaginal birth at term by either spontaneous labor or induction of labor, were recruited.
Interventions
Women were assigned to 50 mg oral sildenafil citrate every 8 hours up to 150 mg or equivalent placebo.
Main Outcome and Measures
The primary composite outcome was intrapartum stillbirth, neonatal death, Apgar score less than 4 at 5 minutes (a score of <4 at 5 minutes is indicative of severe neonatal depression at birth, with scores ranging from 0 to 10), acidosis at birth (umbilical cord artery pH <7.0), hypoxic ischemic encephalopathy, neonatal seizures, neonatal respiratory support for greater than 4 hours, neonatal unit admission for greater than 48 hours, persistent pulmonary hypertension of the newborn, or meconium aspiration…
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: 3,257 participants or records.
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