Safety and efficacy of sildenafil citrate to reduce operative birth for intrapartum fetal compromise at term: A Phase 2 Randomized Controlled Trial
Abstract
BACKGROUND AND OBJECTIVE
Sildenafil citrate is a vasodilator used in erectile dysfunction and pulmonary hypertension. We tested whether it reduces emergency operative births for fetal compromise and improves fetal or utero-placental perfusion in labor in a Phase II double blind randomized controlled trial.
STUDY DESIGN
Women at term in early labor or undergoing scheduled induction of labor at Mater Mother's Hospital, Brisbane, Australia were randomly allocated 50mg sildenafil citrate orally 8 hourly up to 150mg, or placebo. Intrapartum fetal monitoring followed Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines. Primary outcomes were (i) emergency operative birth (by cesarean section or instrumental vaginal birth) for intrapartum fetal compromise and (ii) mean indices of fetal and utero-placental perfusion using Doppler ultrasound. Analysis was by intention-to-treat.
TRIAL REGISTRATION NUMBER
ANZCTRN12615000319572 RESULTS: Between September 2015 and January 2019, 300 women were randomized equally to sildenafil citrate or placebo. Sildenafil citrate reduced the risk of emergency operative birth by 51% (18% vs. 36.7%; RR 0.49, 95% CI 0.33-0.73, p=0.0004, number needed to treat = 5 (3-11)). There was no difference in indices of fetal and utero-placental perfusion, but these were ascertained in only 71 women. Sildenafil citrate reduced the risk of meconium stained liquor or pathological fetal heart rate patterns by 43% (25.3% vs. 44.7%; RR…
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: 71 participants or records.
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