Alessandra Carvalho
SARAH Network of Rehabilitation Hospitals, Salvador, Bahia, Brazil.
Camila Awad
Centro de Epidemiología y Políticas de la Salud, Universidad del Desarrollo, Santiago, Chile
Alessia Gallucci
School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
Ana Paula Flores
Universidad Francisco Marroquin School of Medicine, Guatemala
Anibal La Riva
Department of Surgery, Cleveland Clinic, Cleveland, Ohio, USA
Daniel Díaz-Gil
Department of Cardiac Surgery, Boston Children's Hospital/ Har- vard Medical School, Boston, MA, USA
Deivid da Silva
Department of Radiation Oncology, D’Or Oncology - IDOR Insti- tute - Rio de Janeiro, Brazil
Taylor J Saraceno
Department of Neurology, Brigham and Women’s Hospital, Boston, MA, US
Oswaldo Rivera
Ph.D program in Robotics and Mechatronics Systems, ESIME, Insti- tuto Politécnico Nacional, Ciudad de México, México
Stephan Fricke
Clinic for Hematology, Oncology and Stem Cell Transplantation, Klinikum Chemnitz gGmbH, Bürgerstraße 2, 09113 Chemnitz, Germany
Regina Garcia
Tecnológico de Monterrey, servicio médico, Campus Santa Fe, Ciudad de México, México
Steven Zhou
Acupuncture Program, Central College, New Westminster, BC, Canada
Maria Bazan
Maria Castellaro
MD, Residencia de pediatría Hospital J.P Garrahan, Buenos Aires, Argentina
Luiza Alencar
Pedro López-Blanco
Eliluane Teixeira
Departement of Nuclear Medecine, Hôpitaux Universitaire de Genève, Switzerland
Roberta Gonçalves
Federal University of Amazonas, Manaus, Brazil
Priscila Etchebehere
Department of Clinical Oncology, São Camilo Oncology - São Paulo, Brazil
Jessica Gonzalez
MD. Department of surgery, University of Miami Miller School of Medicine / Holy Cross, Miami, FL, USA
Tasneem Abdallah
A. K. Abdallah, Internal Medicine department, Hamad Medical Corporation, Doha, Qatar
Malaz Hamad Darmood
Hamad Medical Corporation
Shiema Ahmed
PharmD - Clinical pharmacist - Pharmacy Department,Communicable Disease Center , Hamad Medical Corporation, Doha, Qatar
Paola Mendez
Escuela de medicina, Universidad Peruana de Ciencias Apli- cadas, Lima, Perú
Saif Faisal
Pharmacy department, King Abdullah Medical City, Makkah re- gion, Saudi Arabia
Devy Robladillo
Dresden International University
Judith Gutierrez
MD - Department of Family and Community Medicine, Baylor College of Medicine, Houston, Texas, USA
Metteo Guidetti
Aldo Ravelli Research Center for Neurotechnology and Experi- mental Neurotherapeut ics, Department of Health Sciences, Univer- sity of Milan, via Antonio di Rudinì, 8, 20142 Milan,Italy; Department of Electronics, Information and Bioengineering, Politecnico di Milano, Piazza Leonardo da Vinci, 32 20133 Milan, Italy
Nebal Hussein
Inselspital, Univers ity Hospital Bern, Switzerland, Lung Precision Medicine, Department for BioMedical Research, University of Bern, Switzerland
Abstract
ABSTRACT
Background/Objective: In pregnant women with inherited thrombophilia (IT) and recurrent pregnancy loss, there is no higher-level evidence proving the beneficial effects of anticoagulation or platelet inhibition in preventing miscarriages. We hypothesize that anticoagulation with low molecular weight heparin (LMWH) and/or platelet aggregation inhibition with aspirin will increase the proportion of live birth in this population.
Methods: In this phase IIb, factorial, randomized, triple blinded, placebo-controlled (double dummy) clinical trial, pregnant women age 18 to 40 with a history of IT and 2 or more previous miscarriages will be randomized and stratified by age and number of miscarriages in a 2x2 factorial design will be allocated equally to one of the four arms. The primary outcome of live birth will be analyzed through logistic regression analysis, controlling for strata, and results will be reported as odds ratio (OR) and 95% confidence intervals (CIs). Analyzed similarly, the secondary outcomes will include pregnancy loss, maternal mortality, major bleeding events, medication-associated adverse events, placental abruption, preterm birth, and gestational age at delivery. We will perform subgroup analysis for smoking status, weight, age, number of miscarriages, and type of thrombophilia.
Discussion: There is lack of evidence for the use of anticoagulants to prevent pregnancy loss in women with inherited thrombophilia, despite the common diverging prescribing practice predominantly extrapolated from observations in acquired thrombophilia. With this study, we aim to provide an evidence base to create a standard of care in cases of recurrent pregnancy loss in women with IT.
Keywords: heparin; aspirin; inherited thrombophilia; pregnant; live birth
