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Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study
E. Llurba, F. Crispi, F. Crovetto, L. Youssef, JL. Delgado, I. Puig, J. Mora, L. Krofta, K. Mackova, A. Martinez-Varea, A. Tubau, A. Ruiz, A. Paya, M. Prat, F. Chantraine, C. Comas, A. Kajdy, MF. Lopez-Tinajero, F. Figueras, E. Gratacos, PE37 study group
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu protokol klinické studie, časopisecké články
Free Medical Journals od 2011
PubMed Central od 2011
Europe PubMed Central od 2011
ProQuest Central od 2011-01-01
Open Access Digital Library od 2011-01-01
Open Access Digital Library od 2011-01-01
Nursing & Allied Health Database (ProQuest) od 2011-01-01
Health & Medicine (ProQuest) od 2011-01-01
Family Health Database (ProQuest) od 2011-01-01
Psychology Database (ProQuest) od 2011-01-01
ROAD: Directory of Open Access Scholarly Resources od 2011
Odkazy
PubMed
38458783
DOI
10.1136/bmjopen-2023-076201
Knihovny.cz E-zdroje
- MeSH
- biologické markery MeSH
- císařský řez MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- novorozenec MeSH
- placentární růstový faktor MeSH
- prediktivní hodnota testů MeSH
- preeklampsie * diagnóza prevence a kontrola epidemiologie MeSH
- randomizované kontrolované studie jako téma MeSH
- receptor 1 pro vaskulární endoteliální růstový faktor MeSH
- těhotenství MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
INTRODUCTION: Pre-eclampsia affects ~5%-7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal-fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35-37 weeks' gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35-37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes. METHODS AND ANALYSIS: We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35-37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect). ETHICS AND DISSEMINATION: The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences. TRIAL REGISTRATION NUMBER: NCT04766866.
Biochemistry Hospital Sant Pau Barcelona Spain
Centre Hospitalier Universitaire de Liège Liege Belgium
Hospital Clinic de Barcelona Barcelona Spain
Hospital del Mar Barcelona Spain
Hospital Germans Trias i Pujol Badalona Spain
Hospital Politécnico y Universitario La Fe Valencia Spain
Obstetrician Son Llàtzer Hospital Palma de Mallorca Illes Balears Spain
Obstetrics and Gynecology Hospital de la Santa Creu i Sant Pau Barcelona Spain
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