STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials

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dc.contributor.authorPels, A.
dc.contributor.authorKenny, Louise C.
dc.contributor.authorAlfirevic, Zarko
dc.contributor.authorBaker, Philip N.
dc.contributor.authorvon Dadelszen, Peter
dc.contributor.authorGluud, C.
dc.contributor.authorKariya, C. T.
dc.contributor.authorMol, B. W.
dc.contributor.authorPapageorghiou, A. T.
dc.contributor.authorvan Wassenaer-Leemhuis, A. G.
dc.contributor.authorGanzevoort, W.
dc.contributor.authorGroom, K. M.
dc.contributor.funderMedical Research Council
dc.contributor.funderNational Institute for Health Research
dc.contributor.funderZonMw
dc.contributor.funderHealth Research Board
dc.contributor.funderCanadian Institutes of Health Research
dc.contributor.funderNurture Foundation for Reproductive Research
dc.contributor.funderCure Kids
dc.contributor.funderHealth Research Council of New Zealand
dc.contributor.funderCopenhagen Trial Unit
dc.date.accessioned2018-02-06T13:36:29Z
dc.date.available2018-02-06T13:36:29Z
dc.date.issued2017
dc.description.abstractBackground: Severe, early-onset fetal growth restriction due to placental insufficiency is associated with a high risk of perinatal mortality and morbidity with long-lasting sequelae. Placental insufficiency is the result of abnormal formation and function of the placenta with inadequate remodelling of the maternal spiral arteries. There is currently no effective therapy available. Some evidence suggests sildenafil citrate may improve uteroplacental blood flow, fetal growth, and meaningful infant outcomes. The objective of the Sildenafil TheRapy In Dismal prognosis Early onset fetal growth Restriction (STRIDER) collaboration is to evaluate the effectiveness of sildenafil versus placebo in achieving healthy perinatal survival through the conduct of randomised clinical trials and systematic review including individual patient data meta-analysis. Methods: Five national/bi-national multicentre randomised placebo-controlled trials have been launched. Women with a singleton pregnancy between 18 and 30 weeks with severe fetal growth restriction of likely placental origin, and where the likelihood of perinatal death/severe morbidity is estimated to be significant are included. Participants will receive either sildenafil 25 mg or matching placebo tablets orally three times daily from recruitment to 32 weeks gestation. Discussion: The STRIDER trials were conceived and designed through international collaboration. Although the individual trials have different primary outcomes for reasons of sample size and feasibility, all trials will collect a standard set of outcomes including survival without severe neonatal morbidity at time of hospital discharge. This is a summary of all the STRIDER trial protocols and provides an example of a prospectively planned international clinical research collaboration. All five individual trials will contribute to a pre-planned systematic review of the topic including individual patient data meta-analysisen
dc.description.sponsorshipHealth Research Council (New Zealand Project Grant 13/242); Cure Kids (3565); Nurture Foundation for Reproductive Research (Neonatal Sub-study); Health Research Board (HRA-2014-DI-620); ZonMW (80–83,600–98-20,081); National Institute for Health Research/Medical Research Council (Efficacy and Mechanism Evaluation 12–62-109)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid440
dc.identifier.citationPels, A., Kenny, L. C., Alfirevic, Z., Baker, P. N., von Dadelszen, P., Gluud, C., Kariya, C. T., Mol, B. W., Papageorghiou, A. T., van Wassenaer-Leemhuis, A. G., Ganzevoort, W. and Groom, K. M. (2017) 'STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials', BMC Pregnancy and Childbirth, 17, 440 (8pp). doi: 10.1186/s12884-017-1594-zen
dc.identifier.doi10.1186/s12884-017-1594-z
dc.identifier.endpage8
dc.identifier.journaltitleBMC Pregnancy and Childbirthen
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/5405
dc.identifier.volume17
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urihttps://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-017-1594-z
dc.rights© 2017, the Authors. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectFetal growth restrictionen
dc.subjectPlacental insufficiencyen
dc.subjectSildenafilen
dc.subjectRandomised placebo controlled trialen
dc.subjectNeonatal mortalityen
dc.subjectNeonatal morbidityen
dc.titleSTRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trialsen
dc.typeArticle (peer-reviewed)en
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