دورية أكاديمية
أعرض في EDS

OPtimal TIming of antenatal COrticosteroid administration in pregnancies complicated by early-onset fetal growth REstriction (OPTICORE): study protocol of a multicentre, retrospective cohort study.

التفاصيل البيبلوغرافية
العنوان: OPtimal TIming of antenatal COrticosteroid administration in pregnancies complicated by early-onset fetal growth REstriction (OPTICORE): study protocol of a multicentre, retrospective cohort study.
المؤلفون: van de Meent M; Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands., Kleuskens DG; Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands., Ganzevoort W; Department of Obstetrics and Gynaecology, Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands., Gordijn SJ; Department of Obstetrics and Gynaecology, University Medical Center Groningen, Groningen, Netherlands., Kooi EMW; Department of Pediatrics, University Medical Center Groningen, Groningen, Netherlands., Onland W; Department of Pediatrics, Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands.; Amsterdam Reproduction and Development, Amsterdam, Netherlands., van Rijn BB; Department of Obstetrics and Gynaecology, Erasmus MC, Rotterdam, Netherlands., Duvekot JJ; Department of Obstetrics and Gynaecology, Erasmus MC, Rotterdam, Netherlands., Kornelisse RF; Department of Pediatrics, Erasmus MC Sophia, Rotterdam, Netherlands., Al-Nasiry S; Department of Obstetrics and Gynaecology, Maastricht UMC+, Maastricht, Netherlands., Jellema RK; Department of Pediatrics, Maastricht UMC+, Maastricht, Netherlands., Knol HM; Department of Obstetrics and Gynaecology, Isala Zwolle, Zwolle, Netherlands., Manten GTR; Department of Obstetrics and Gynaecology, Isala Zwolle, Zwolle, Netherlands., Mulder-de Tollenaer SM; Department of Pediatrics, Isala Zwolle, Zwolle, Netherlands., Derks JB; Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands., Groenendaal F; Department of Neonatology, University Medical Center Utrecht, Utrecht, Netherlands., Bekker MN; Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands., Schuit E; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Lely AT; Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands., Kooiman J; Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands j.kooiman@umcutrecht.nl.
المصدر: BMJ open [BMJ Open] 2023 Mar 17; Vol. 13 (3), pp. e070729. Date of Electronic Publication: 2023 Mar 17.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Fetal Growth Retardation* , Premature Birth*/prevention & control, Pregnancy ; Infant, Newborn ; Humans ; Female ; Retrospective Studies ; Fetal Hypoxia ; Stillbirth ; Adrenal Cortex Hormones ; Ultrasonography, Prenatal ; Gestational Age ; Multicenter Studies as Topic
مستخلص: Introduction: Early-onset fetal growth restriction (FGR) requires timely, often preterm, delivery to prevent fetal hypoxia causing stillbirth or neurologic impairment. Antenatal corticosteroids (CCS) administration reduces neonatal morbidity and mortality following preterm birth, most effectively when administered within 1 week preceding delivery. Optimal timing of CCS administration is challenging in early-onset FGR, as the exact onset and course of fetal hypoxia are unpredictable. International guidelines do not provide a directive on this topic. In the Netherlands, two timing strategies are commonly practiced: administration of CCS when the umbilical artery shows (A) a pulsatility index above the 95th h centile and (B) absent or reversed end-diastolic velocity (a more progressed disease state). This study aims to (1) use practice variation to compare CCS timing strategies in early-onset FGR on fetal and neonatal outcomes and (2) develop a dynamic tool to predict the time interval in days until delivery, as a novel timing strategy for antenatal CCS in early-onset FGR.
Methods and Analysis: A multicentre, retrospective cohort study will be performed including pregnancies complicated by early-onset FGR in six tertiary hospitals in the Netherlands in the period between 2012 and 2021 (estimated sample size n=1800). Main exclusion criteria are multiple pregnancies and fetal congenital or genetic abnormalities. Routinely collected data will be extracted from medical charts. Primary outcome for the comparison of the two CCS timing strategies is a composite of perinatal, neonatal and in-hospital mortality. Secondary outcomes include the COSGROVE core outcome set for FGR. A multivariable, mixed-effects model will be used to compare timing strategies on study outcomes. Primary outcome for the dynamic prediction tool is 'days until birth'.
Ethics and Dissemination: The need for ethical approval was waived by the Ethics Committee (University Medical Center Utrecht). Results will be published in open-access, peer-reviewed journals and disseminated by presentations at scientific conferences.
Trial Registration Number: ClinicalTrials.gov: NCT05606497.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
References: Acta Obstet Gynecol Scand. 2020 Feb;99(2):153-166. (PMID: 31376293)
Ultrasound Obstet Gynecol. 2001 Dec;18(6):564-70. (PMID: 11844190)
Ann Oncol. 2015 Jun;26(6):1254-1262. (PMID: 25862439)
Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. (PMID: 26909664)
Obstet Gynecol. 2021 Feb 1;137(2):e16-e28. (PMID: 33481528)
Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. (PMID: 11401896)
Neonatology. 2019;116(3):227-235. (PMID: 31108490)
Front Pediatr. 2016 Oct 20;4:114. (PMID: 27812521)
BMJ. 2020 Mar 18;368:m441. (PMID: 32188600)
Lancet. 2015 May 30;385(9983):2162-72. (PMID: 25747582)
Hypertension. 2018 Jul;72(1):24-43. (PMID: 29899139)
Cochrane Database Syst Rev. 2020 Dec 25;12:CD004454. (PMID: 33368142)
Obstet Gynecol Clin North Am. 2020 Mar;47(1):81-98. (PMID: 32008673)
N Engl J Med. 2007 Sep 20;357(12):1190-8. (PMID: 17881751)
Lancet Respir Med. 2017 Aug;5(8):657-666. (PMID: 28687343)
N Engl J Med. 2011 Jan 20;364(3):255-64. (PMID: 21247316)
JAMA. 1995 Feb 1;273(5):413-8. (PMID: 7823388)
J Pediatr. 1978 Apr;92(4):529-34. (PMID: 305471)
Am J Obstet Gynecol. 2018 Feb;218(2S):S818-S828. (PMID: 29422213)
Clin Obstet Gynecol. 2006 Jun;49(2):228-35. (PMID: 16721103)
Diagn Progn Res. 2018 Dec 18;2:23. (PMID: 31093570)
Ultrasound Obstet Gynecol. 2014 Jan;43(1):34-40. (PMID: 23754253)
Am J Obstet Gynecol. 2019 Oct;221(4):339.e1-339.e10. (PMID: 31152710)
JAMA Pediatr. 2017 Jul 1;171(7):678-686. (PMID: 28505223)
Vaccine. 2019 Dec 10;37(52):7596-7609. (PMID: 31783981)
Int J Gynaecol Obstet. 2021 Mar;152 Suppl 1:3-57. (PMID: 33740264)
Am J Obstet Gynecol. 2018 Feb;218(2S):S745-S761. (PMID: 29422210)
Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. (PMID: 32738107)
Ultrasound Obstet Gynecol. 2013 Oct;42(4):400-8. (PMID: 24078432)
BJOG. 2007 Sep;114(9):1072-8. (PMID: 17617191)
BMC Med Res Methodol. 2017 Jan 19;17(1):8. (PMID: 28103817)
Dev Med Child Neurol. 2005 Aug;47(8):571-6. (PMID: 16108461)
J Clin Epidemiol. 2005 Mar;58(3):246-51. (PMID: 15718113)
Am J Obstet Gynecol MFM. 2020 Nov;2(4):100215. (PMID: 33345924)
Am J Obstet Gynecol. 2011 Jan;204(1):34.e1-9. (PMID: 21056403)
Am J Obstet Gynecol. 2019 Apr;220(4):383.e1-383.e17. (PMID: 30576661)
Ir Med J. 2018 May 10;111(5):747. (PMID: 30489707)
Obstet Gynecol. 2015 Jun;125(6):1377-1384. (PMID: 26000509)
فهرسة مساهمة: Keywords: EPIDEMIOLOGY; NEONATOLOGY; OBSTETRICS
سلسلة جزيئية: ClinicalTrials.gov NCT05606497
المشرفين على المادة: 0 (Adrenal Cortex Hormones)
تواريخ الأحداث: Date Created: 20230317 Date Completed: 20230321 Latest Revision: 20230324
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC10030622
DOI: 10.1136/bmjopen-2022-070729
PMID: 36931680
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2022-070729