مورد إلكتروني
Prolong: A double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia. A clinical trial protocol.
| العنوان: | Prolong: A double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia. A clinical trial protocol. |
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| بيانات النشر: | BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com) United Kingdom 2019-11-15 |
| تفاصيل مُضافة: | Palmer, Kirsten R. Wallace E.M. Marshall S.A. Langston-Cox A.G. |
| نوع الوثيقة: | Electronic Resource |
| مستخلص: | Introduction Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. There is a need for adjuvant, targeted therapies to improve outcomes. Broccoli sprout extract, rich in the antioxidant sulforaphane, reduces oxidative stress and placental secretion of the antiangiogenic factors that contribute to vascular dysfunction in preeclampsia. We propose a phase III trial investigating broccoli sprout extract. We will assess broccoli sprout extract in women with early onset (<34 weeks) preeclampsia, investigating (1) the interval between enrolment and delivery (days), (2) biomarkers of placental and endothelial function and (3) maternal and fetal outcomes. Methods A double-blind, placebo-controlled randomised trial will be conducted at Monash Health, Melbourne, Australia. One hundred and eighty women (45 each arm of each stratum) with early onset preeclampsia (defined as per Society for Obstetric Medicine of Australia and New Zealand guidelines) will be recruited. Consenting women will be randomised to receive an oral dose of either broccoli sprout extract (24 mg of activated sulforaphane) or identical placebo, twice daily until delivery. Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites. Maternal and perinatal outcomes will be monitored throughout. All clinical care decisions, including the timing of delivery, will be made by the treating team, blinded to treatment allocation. Participation in this trial will not affect routine care. At delivery, maternal and cord blood and placentae will be collected to measure sulforaphane metabolites and sFlt-1, PlGF, sEng and activin A. Ethics and dissemination Approval to conduct the trial has been granted by Monash Health Human Research and Ethics Committee (RES-18-0000-109A). Deidentified data |
| مصطلحات الفهرس: | fetus outcome, broccoli sprout extract/dt [Drug Therapy], broccoli sprout extract/po [Oral Drug Administration], broccoli sprout extract/pd [Pharmacology], broccomax, adult, Apgar score, article, broccoli, clinical trial protocol, controlled study, double blind procedure, drug monitoring, drug safety, drug tolerability, endothelial dysfunction, female, broccoli sprout extract/cm [Drug Comparison], human, major clinical study, maternal blood, phase 3 clinical trial, placenta function, preeclampsia/dt [Drug Therapy], pregnancy outcome, randomized controlled trial, umbilical cord blood, activin A/ec [Endogenous Compound], endoglin/ec [Endogenous Compound], placental growth factor/ec [Endogenous Compound], plant extract/ct [Clinical Trial], plant extract/cm [Drug Comparison], plant extract/dt [Drug Therapy], plant extract/po [Oral Drug Administration], plant extract/pd [Pharmacology], sulforaphane, unclassified drug, vasculotropin receptor 1/ec [Endogenous Compound], broccoli sprout extract/ct [Clinical Trial], Article |
| URL: | BMJ Open LibKey Link |
| الإتاحة: | Open access content. Open access content Copyright 2019 Elsevier B.V., All rights reserved. |
| أرقام أخرى: | AUSHL oai:repository.monashhealth.org:1/35794 BMJ Open. 9 (10) (no pagination), 2019. Article Number: 027493. Date of Publication: 01 Oct 2019. 2044-6055 (electronic) https://repository.monashhealth.org/monashhealthjspui/handle/1/35794Test Obstetrics and Gynaecology (Monash Women's) 31628121 [http://www.ncbi.nlm.nih.gov/pubmed/?term=31628121Test] 629627777 (Langston-Cox, Marshall, Palmer, Wallace) Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia (Langston-Cox, Marshall, Wallace) Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia (Palmer) Monash Women's, Monash Health, Clayton, VIC, Australia Wallace E.M.; euan.wallace@monash.edu 1305119579 |
| المصدر المساهم: | MONASH HEALTH LIBRS From OAIster®, provided by the OCLC Cooperative. |
| رقم الانضمام: | edsoai.on1305119579 |
| قاعدة البيانات: | OAIster |
| الوصف غير متاح. |