Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study.

Autor:	Llurba E; Obstetrics and Gynecology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Crispi F; BCNatal, Fetal Medicine Research Center, Hospital Clínic and Hospital Sant Joan de Déu, University of Barcelona, Barcelona, Spain., Crovetto F; Hospital Clinic de Barcelona, Barcelona, Spain., Youssef L; IDIBAPS, Barcelona, Spain., Delgado JL; Unidad Medicina Fetal Murcia, IMIB Arrixaca, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain., Puig I; Unidad Medicina Fetal Murcia, IMIB Arrixaca, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain., Mora J; Biochemistry, Hospital Sant Pau, Barcelona, Spain., Krofta L; Institute for the Care of Mother and Child, Third Faculty of Medicine, Charles University, Prague, Czech Republic., Mackova K; Institute for the Care of Mother and Child, Third Faculty of Medicine, Charles University, Prague, Czech Republic., Martinez-Varea A; Hospital Politécnico y Universitario La Fe, Valencia, Spain., Tubau A; Obstetrician, Son Llàtzer Hospital, Palma de Mallorca, Illes Balears, Spain., Ruiz A; Obstetrician, Son Llàtzer Hospital, Palma de Mallorca, Illes Balears, Spain., Paya A; Hospital del Mar, Barcelona, Spain., Prat M; Hospital del Mar, Barcelona, Spain., Chantraine F; Centre Hospitalier Universitaire de Liège, Liege, Belgium., Comas C; Hospital Germans Trias i Pujol, Badalona, Spain., Kajdy A; Centre of Postgraduate Medical Education, Obstetrics and Gynecology and Perinatal Medicine, Warsaw, Poland., Lopez-Tinajero MF; Hospital Clinic de Barcelona, Barcelona, Spain., Figueras F; BCNatal, Fetal Medicine Research Center, Hospital Clínic and Hospital Sant Joan de Déu, University of Barcelona, Barcelona, Spain FFIGUERA@clinic.cat., Gratacos E; Hospital Clinic de Barcelona, Barcelona, Spain.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Mar 08; Vol. 14 (3), pp. e076201. Date of Electronic Publication: 2024 Mar 08.
DOI:	10.1136/bmjopen-2023-076201
Abstrakt:	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. Competing Interests: Competing interests: Roche Diagnostics International (Switzerland) will provide at no cost the assays for the sFlt-1 and PlGF measurements (Elecsys). EL has received financial support for her presentations from Cook and Roche Diagnostics. JLD has received fees for advisory services from Roche Diagnostics. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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