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

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.

La rata Wistar como modelo animal experimental, para el adiestramiento laparoscópico de residentes con entrenadores pélvicos / Wistar rats as an experimental animal model for use with gynecological pelvi-trainers in surgical resident physicians

Presentamos nuevos ejercicios de entrenamiento endoscópico ginecológico en modelo animal (rata Wistar) para formación de los residentes en esta disciplina quirúrgica. Las intervenciones y los ejercicios de adiestramiento se efectuarán en una rata Wistar viva y anestesiada, introducida en un entrenador pélvico endoscópico ginecológico. A través del mismo se realizarán en la rata las prácticas de disección, coagulación, corte, movilización de estructuras de cavidad abdominal, histerectomía subtotal con anexectomía bilateral, extracción de pieza en bolsa y anudado para cerrar la herida abdominal. Con 12h de trabajo un residente de obstetricia y ginecología en su tercer año conseguiría el dominio de los movimientos necesarios para realizarlos en humanos (AU)

We describe a new animal model for training resident physicians in gynecological endoscopy. The surgery and training exercises are performed in live, anesthetized, Wistar rats in a pelvitrainer for gynecological endoscopy. The pelvitrainer is used to practice dissection, cutting, electrocoagulation, mobilization of structures in the abdominal cavity, subtotal hysterectomy with double anexectomy, extraction of the surgical specimen in a bag, and knotting to close the surgical wound. Twelve hours of training are sufficient for third-year resident surgeons to master the movements required to perform these techniques in humans (AU)