000075785 001__ 75785
000075785 005__ 20220621094623.0
000075785 0247_ $$2doi$$a10.1136/bmjopen-2017-020501
000075785 0248_ $$2sideral$$a108774
000075785 037__ $$aART-2018-108774
000075785 041__ $$aeng
000075785 100__ $$aMazarico, E.
000075785 245__ $$aStudy protocol for a randomised controlled trial: Treatment of early intrauterine growth restriction with low molecular weight heparin (TRACIP)
000075785 260__ $$c2018
000075785 5060_ $$aAccess copy available to the general public$$fUnrestricted
000075785 5203_ $$aIntroduction 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.
000075785 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII-FEDER/PI15-00151
000075785 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/
000075785 590__ $$a2.376$$b2018
000075785 591__ $$aMEDICINE, GENERAL & INTERNAL$$b50 / 159 = 0.314$$c2018$$dQ2$$eT1
000075785 592__ $$a1.321$$b2018
000075785 593__ $$aMedicine (miscellaneous)$$c2018$$dQ1
000075785 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000075785 700__ $$aPeguero, A.
000075785 700__ $$aCamprubí, M.
000075785 700__ $$aRovira, C.
000075785 700__ $$aGomez Roig, M.D.
000075785 700__ $$0(orcid)0000-0002-8476-9161$$aOros, D.$$uUniversidad de Zaragoza
000075785 700__ $$aIbáñez-Burillo, P.
000075785 700__ $$aSchoorlemmer, J.
000075785 700__ $$aMasoller, N.
000075785 700__ $$aTàssies, M.D.
000075785 700__ $$aFigueras, F.
000075785 7102_ $$11004$$2645$$aUniversidad de Zaragoza$$bDpto. Cirugía,Ginecol.Obstetr.$$cÁrea Obstetricia y Ginecología
000075785 773__ $$g8, 10 (2018), e020501 [7 pp]$$pBMJ Open$$tBMJ Open$$x2044-6055
000075785 8564_ $$s211815$$uhttps://zaguan.unizar.es/record/75785/files/texto_completo.pdf$$yVersión publicada
000075785 8564_ $$s129281$$uhttps://zaguan.unizar.es/record/75785/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000075785 909CO $$ooai:zaguan.unizar.es:75785$$particulos$$pdriver
000075785 951__ $$a2022-06-21-09:40:08
000075785 980__ $$aARTICLE