Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term : protocol of the PE37 study
Llurba, E (Institut de Recerca Sant Pau)
Crispi, Fatima (Hospital Clínic i Provincial de Barcelona)
Crovetto, Francesca (Hospital Clínic i Provincial de Barcelona)
Youssef, Lina (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Delgado, Juan Luis (Hospital Clínico Universitario Virgen de la Arrixaca (El Palmar, Múrcia))
Puig, Isabel (Hospital Clínico Universitario Virgen de la Arrixaca (El Palmar, Múrcia))
Mora, Josefina (Institut de Recerca Sant Pau)
Krofta, Ladislav (Charles University)
Mackova, Katerina (Charles University)
Martinez-Varea, Alicia (Hospital Universitari i Politècnic La Fe (València))
Tubau Navarra, Albert (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Ruiz, Aina (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Paya, Antoni (Hospital del Mar (Barcelona, Catalunya))
Prat, Maria (Hospital del Mar (Barcelona, Catalunya))
Chantraine, Frederic (Centre Hospitalier Universitaire de Liège)
Comas, Carmina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Kajdy, Anna (Centre of Postgraduate Medical Education)
Lopez-Tinajero, Maria Fernanda (Hospital Clínic i Provincial de Barcelona)
Figueras, Francesc (Hospital Clínic i Provincial de Barcelona)
Gratacós, Eduard (Hospital Clínic i Provincial de Barcelona)
Castillo, Heidi (Hospital Clínic i Provincial de Barcelona)
Casas, I. (Hospital Clínic i Provincial de Barcelona)
Campos, Rafael José (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Timmermans, Marie (Centre Hospitalier Universitaire de Liège)
Parriego, Vanessa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Sys, Dorota (Centre of Postgraduate Medical Education)
Modzelewski, Jan (Centre of Postgraduate Medical Education)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	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. 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). 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.
Ajuts:	Instituto de Salud Carlos III PI17/01350 Instituto de Salud Carlos III PI22/00109
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Biomarkers ; Cesarean Section ; Female ; Humans ; Infant, Newborn ; Multicenter Studies as Topic ; Placenta Growth Factor ; Pre-Eclampsia ; Predictive Value of Tests ; Pregnancy ; Randomized Controlled Trials as Topic ; Vascular Endothelial Growth Factor Receptor-1
Publicat a:	BMJ open, Vol. 14 Núm. 3 (august 2024) , p. e076201, ISSN 2044-6055

DOI: 10.1136/bmjopen-2023-076201
PMID: 38458783

7 p, 351.5 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut de Recerca Sant Pau
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