Halting the Canadian STRIDER randomised controlled trial of sildenafil for severe, early-onset fetal growth restriction: ethical, methodological, and pragmatic considerations.
Peter Von DadelszenFrançois AudibertEmmanuel BujoldJeffrey N BoneAsh SandhuJing LiChirag KariyaYoukee ChungTang LeeKelvin AuM Amanda SkollMarianne VidlerLaura A MageeBruno PiedboeufPhilip N BakerSayrin LaljiKenneth I LimPublished in: BMC research notes (2022)
Between May 2017 and June 2018, 21 (90 planned) women were randomised [10 sildenafil; 11 placebo (1 withdrawal)]. Baseline characteristics, PLGF levels, maternal and perinatal outcomes, and adverse events did not differ. Delivery GA: 26 + 6 weeks (sildenafil) vs 29 + 2 weeks (placebo); p = 0.200. Data will contribute to an individual participant data meta-analysis.
Keyphrases
- early onset
- study protocol
- pulmonary hypertension
- pulmonary arterial hypertension
- double blind
- late onset
- systematic review
- electronic health record
- placebo controlled
- clinical trial
- gestational age
- big data
- pregnancy outcomes
- birth weight
- pet ct
- phase iii
- open label
- pregnant women
- randomized controlled trial
- polycystic ovary syndrome
- meta analyses
- type diabetes
- machine learning
- physical activity
- skeletal muscle
- weight gain