Study protocol for a randomised controlled trial: treatment of early intrauterine growth restriction with low molecular weight heparin (TRACIP)
| Autor: | Patricia Ibáñez-Burillo, Jon Schoorlemmer, Carlota Rovira, Daniel Oros, Anna Peguero, Maria Dolors Tàssies, Narcís Masoller, Edurne Mazarico, Maria Dolores Gómez Roig, Francesc Figueras, M Camprubí |
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| Rok vydání: | 2018 |
| Předmět: |
fetal medicine
prenatal diagnosis Perinatal Death Diagnòstic prenatal Prenatal diagnosis Intrauterine growth restriction 030204 cardiovascular system & hematology law.invention 0302 clinical medicine Randomized controlled trial Retard del creixement intrauterí Pregnancy law Obstetrics and Gynaecology Protocol Multicenter Studies as Topic Randomized Controlled Trials as Topic Fetal Growth Retardation 030219 obstetrics & reproductive medicine Obstetrics Pregnancy Outcome Gestational age Fetal ultrasonic imaging ultrasonography General Medicine Intention to Treat Analysis Gestation Female medicine.medical_specialty Ecografia fetal medicine.drug_class Low molecular weight heparin Gestational Age Placental insufficiency Fetal growth retardation 03 medical and health sciences medicine Humans business.industry Infant Newborn Heparin Low-Molecular-Weight Placental Insufficiency medicine.disease Clinical trial Linear Models business |
| Zdroj: | BMJ Open r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu instname r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu Fundació Sant Joan de Déu Zaguán. Repositorio Digital de la Universidad de Zaragoza |
| ISSN: | 2044-6055 |
| Popis: | IntroductionThe 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 analysisThis 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 disseminationThe 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 registrywww.clinicaltrial.gov. according to Science Law 14/2011, and the results will be published in an open access journal.Trial registration numberNCT03324139; Pre-results. |
| Databáze: | OpenAIRE |
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