STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials.pdf (395.7 kB)
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STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials.

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posted on 17.01.2018, 16:29 by A. Pels, L. C. Kenny, Z. Alfirevic, P. N. Baker, P. von Dadelszen, C. Gluud, C. T. Kariya, B. W. Mol, A. T. Papageorghiou, A. G. van Wassenaer-Leemhuis, W. Ganzevoort, K. M. Groom, international STRIDER Consortium
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.

Funding

Funding: New Zealand/Australia: Health Research Council New Zealand Project Grant 13/242, Cure Kids Grant 3565, Nurture Foundation Grant (Neonatal Sub-study). Canada: Canadian Institutes of Health Research (CIHR). Ireland: Health Research Board HRA-2014-DI-620. The Netherlands: ZonMW 80–83,600–98-20,081. United Kingdom: EME MRC NIHR 12–62-109. Denmark: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark.

History

Citation

BMC Pregnancy Childbirth, 2017, 17:440

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES

Version

VoR (Version of Record)

Published in

BMC Pregnancy Childbirth

Publisher

BioMed Central

eissn

1471-2393

Acceptance date

23/11/2017

Copyright date

2017

Available date

17/01/2018

Publisher version

https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-017-1594-z

Notes

The datasets that will be generated and/or analysed from these studies will be publicly available once all trials are complete, individual completed trial datasets will be available from the chief investigator of each trial upon reasonable request.

Language

en