Study protocol for a randomised controlled trial: treatment of early intrauterine growth restriction with low molecular weight heparin (TRACIP).

Autor:	Mazarico E; BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Barcelona, Spain.; Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.; Maternal and Child Health and Development Network II (SAMID II), funded by Instituto de Salud Carlos III (ISCIII), Sub-Directorate General for Research Assessment and Promotion and the European Regional Development Fund (ERDF), Barcelona, Spain., Peguero A; Fetal i+D Fetal Medicine Research Center, BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Barcelona, Spain., Camprubí M; BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Barcelona, Spain., Rovira C; Department of Pathology, Hospital Sant Joan de Déu, University of Barcelona, Barcelona, Spain., Gomez Roig MD; BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Barcelona, Spain.; Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.; Maternal and Child Health and Development Network II (SAMID II), funded by Instituto de Salud Carlos III (ISCIII), Sub-Directorate General for Research Assessment and Promotion and the European Regional Development Fund (ERDF), Barcelona, Spain., Oros D; Maternal and Child Health and Development Network II (SAMID II), funded by Instituto de Salud Carlos III (ISCIII), Sub-Directorate General for Research Assessment and Promotion and the European Regional Development Fund (ERDF), Barcelona, Spain.; Aragon Institute for Health Research (IIS Aragón), Obstetrics Department, Hospital Clínico Universitario Zaragoza, Zaragoza, Spain., Ibáñez-Burillo P; Aragon Institute for Health Research (IIS Aragón), Obstetrics Department, Hospital Clínico Universitario Zaragoza, Zaragoza, Spain., Schoorlemmer J; Institute for Health Sciences in Aragon (IACS), Aragon Institute for Health Research (IIS Aragón), Pluripotency in Embryonic Stem Cells group, Centro de Investigación Biomédica de Aragón (CIBA), ARAID Foundation, Zaragoza, Spain., Masoller N; Fetal i+D Fetal Medicine Research Center, BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Barcelona, Spain., Tàssies MD; Department of Hemotherapy Hemostasis, Hospital Clinic de Barcelona, Barcelona, Spain., Figueras F; Fetal i+D Fetal Medicine Research Center, BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Barcelona, Spain.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2018 Oct 23; Vol. 8 (10), pp. e020501. Date of Electronic Publication: 2018 Oct 23.
DOI:	10.1136/bmjopen-2017-020501
Abstrakt:	Introduction: The incidence of intrauterine growth restriction (IUGR) is estimated at about 3% of pregnancies, and it is associated with 30% of all perinatal mortality and severe morbidity with adverse neurodevelopmental and cardiovascular health consequences in adult life. Early onset IUGR represents 20%-30% of all cases and is highly associated with severe placental insufficiency. The existing evidence suggests that low molecular weight heparin (LMWH) has effects beyond its antithrombotic action, improving placental microvessel structure and function of pregnant women with vascular obstetric complications by normalising proangiogenic and antiapoptotic protein levels, cytokines and inflammatory factors. The objective of our study is to demonstrate the effectiveness of LMWH in prolonging gestation in pregnancies with early-onset IUGR. Methods and Analysis: This is a multicentre, triple-blind, parallel-arm randomised clinical trial. Singleton pregnancies qualifying for early (20-32 weeks at diagnosis) placental IUGR (according to Delphi criteria) will be randomised to subcutaneous treatment with bemiparin 3500 IU/0.2 mL/day or placebo from inclusion at diagnosis to the time of delivery. Analyses will be based on originally assigned groups (intention-to-treat). The primary objective will be analysed by comparing gestational age and prolongation of pregnancy (days) in each group with Student's t-tests for independent samples and by comparing Kaplan-Maier survival curves (from inclusion to delivery, log-rank test). A linear regression model for gestational age at birth will consider the following covariates: gestational age at inclusion (continuous) and pre-eclampsia (binary). Ethics and Dissemination: The study will be conducted in accordance with the principles of Good Clinical Practice. This study was approved by the Clinical Research Ethics Committee (CEIC) of Sant Joan de Déu Hospital, on 13 July 2017. The trial is registered in the public registry www.clinicaltrial.gov. according to Science Law 14/2011, and the results will be published in an open access journal. Trial Registration Number: NCT03324139; Pre-results. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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