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ToolsSTRIDER group (2018) Maternal sildenafil for severe fetal growth restriction (STRIDER):a multicentre, randomised, placebo-controlled, double-blind trial. The Lancet Child and Adolescent Health, 2 (2). p. 93. ISSN 2352-4642
Full text not available from this repository.Abstract
Background: Severe early-onset fetal growth restriction can lead to a range of adverse outcomes including fetal or neonatal death, neurodisability, and lifelong risks to the health of the affected child. Sildenafil, a phosphodiesterase type 5 inhibitor, potentiates the actions of nitric oxide, which leads to vasodilatation of the uterine vessels and might improve fetal growth in utero. Methods: We did this superiority, placebo-controlled randomised trial in 19 fetal medicine units in the UK. We used random computer allocation (1:1) to assign women with singleton pregnancies between 22 weeks and 0 days' gestation and 29 weeks and 6 days' gestation and severe early-onset fetal growth restriction to receive either sildenafil 25 mg three times daily or placebo until 32 weeks and 0 days' gestation or delivery. We stratified women by site and by their gestational age at randomisation (before week 26 and 0 days or at week 26 and 0 days or later). We defined fetal growth restriction as a combination of estimated fetal weight or abdominal circumference below tenth percentile and absent or reversed end-diastolic blood flow in the umbilical artery on Doppler velocimetry. The primary outcome was the time from randomisation to delivery, measured in days. This study is registered with BioMed Central, number ISRCTN 39133303. Findings: Between Nov 21, 2014, and July 6, 2016, we recruited 135 women and randomly assigned 70 women to sildenafil and 65 women to placebo. We found no difference in the median randomisation to delivery interval between women assigned to sildenafil (17 days [IQR 7–24]) and women assigned to placebo (18 days [8–28]; p=0·23). Livebirths (relative risk [RR] 1·06, 95% CI 0·84 to 1·33; p=0·62), fetal deaths (0·89, 0·54 to 1·45; p=0·64), neonatal deaths (1·33, 0·54 to 3·28; p=0·53), and birthweight (−14 g,–100 to 126; p=0·81) did not differ between groups. No differences were found for any other secondary outcomes. Eight serious adverse events were reported during the course of the study (six in the placebo group and two in the sildenafil group); none of these were attributed to sildenafil. Interpretation: Sildenafil did not prolong pregnancy or improve pregnancy outcomes in severe early-onset fetal growth restriction and therefore it should not be prescribed for this indication outside of research studies with explicit participants' consent.
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| Additional Information: | We would like to thank all the women who participated in this study during such a distressing time for them and their families. We would like to thank the members of the Trial Steering Committee (Alan Cameron, Elizabeth Draper, Paul Clarke, Laura Price, Alex Astor, Louise Hardman, and Karen Wilding), Independent Safety and Data Monitoring Committee (Ed Juszczak, Christoph Lees, and Ben Stenson), members of the STRIDER International collaboration, and all the individuals who helped with the management and conduct of the STRIDER UK study. We thank Sarah Quinby and Ediri O'Brien who provided trial management until August, 2016. We are also grateful to Sharp Clinical Services and University of British Columbia (UBC) for supporting the provision of masked investigational medicinal products to research sites and to staff of pharmacy and research and development departments in all of the participating hospitals. We would also like to thank UBC for the development and support of the STRIDER randomisation and electronic data capture systems and Liverpool Clinical Laboratories, Royal Liverpool University, and Broadgreen Hospital Trust for doing the Elecsys sFlt-1 and PlGF analyses. The EME Programme is funded by the MRC and NIHR, with contributions from the Chief Scientist Office in Scotland and National Institute for Social Care and Research in Wales. The trial was sponsored by the University of Liverpool and Liverpool Women's Hospital. PNB and LCK report a minority shareholding in Metabolomic Diagnostics, outside of the submitted work, and have patents relating to screening tests (not therapy) for pre-eclampsia issued. All other authors declare no competing interests. This report is independent research funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership. The views expressed in this publication are those of the authors and not necessarily those of the MRC, National Health Service, NIHR, or the Department of Health. |
| Uncontrolled Keywords: | pediatrics, perinatology, and child health,developmental and educational psychology ,/dk/atira/pure/subjectarea/asjc/2700/2735 |
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| Depositing User: | LivePure Connector |
| Date Deposited: | 16 Feb 2026 17:30 |
| Last Modified: | 16 Feb 2026 17:30 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/101966 |
| DOI: | 10.1016/S2352-4642(17)30173-6 |
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