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

Show simple item record Pels, A en Kenny, LC en Alfirevic, Z en Baker, Philip en von Dadelszen, Peter en Gluud, C en Kariya, CT en Mol, BW en Papageorghiou, AT en van Wassenaer-Leemhuis, AG en Ganzevoort, W en Allan, Katie en international STRIDER Consortium en 2018-11-26T01:07:18Z en 2017-12-28 en
dc.identifier.issn 1471-2393 en
dc.identifier.uri en
dc.description.abstract BACKGROUND: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-analysis. TRIAL REGISTRATIONS:New Zealand and Australia: ACTRN12612000584831 . Registered 30/05/2012. Canada: NCT02442492 . Registered 05/05/2015. Ireland: CT 900/572/1 . Registered 15/07/2015. The Netherlands: NCT02277132 . Registered 29/09/2014. United Kingdom: ISRCTN39133303 . Registered 31/07/2014. en
dc.format.medium Electronic en
dc.language eng en
dc.relation.ispartofseries BMC pregnancy and childbirth en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. Details obtained from en
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dc.subject international STRIDER Consortium en
dc.subject Humans en
dc.subject Fetal Growth Retardation en
dc.subject Vasodilator Agents en
dc.subject Prognosis en
dc.subject Pregnancy Outcome en
dc.subject Treatment Outcome en
dc.subject Clinical Protocols en
dc.subject Gestational Age en
dc.subject Pregnancy en
dc.subject International Cooperation en
dc.subject Adult en
dc.subject Canada en
dc.subject Australia en
dc.subject Ireland en
dc.subject Netherlands en
dc.subject New Zealand en
dc.subject Female en
dc.subject Young Adult en
dc.subject Sildenafil Citrate en
dc.subject United Kingdom en
dc.title STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials. en
dc.type Journal Article en
dc.identifier.doi 10.1186/s12884-017-1594-z en
pubs.issue 1 en
pubs.begin-page 440 en
pubs.volume 17 en
dc.rights.holder Copyright: The authors en
dc.identifier.pmid 29282009 en
pubs.publication-status Published en
dc.rights.accessrights en
pubs.subtype Research Support, Non-U.S. Gov't en
pubs.subtype research-article en
pubs.subtype Multicenter Study en
pubs.subtype Randomized Controlled Trial en
pubs.subtype Journal Article en
pubs.elements-id 720234 en Liggins Institute en Medical and Health Sciences en Population Health en Epidemiology & Biostatistics en School of Medicine en Obstetrics and Gynaecology en
dc.identifier.eissn 1471-2393 en
pubs.record-created-at-source-date 2017-12-29 en
pubs.dimensions-id 29282009 en

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