Meital Shlomo1,2, Rafael Gorodischer3,4,5,2, Sharon Daniel1,3,4,2, Arnon Wiznitzer6,4,5, Ilan Matok7,2, Boris Fishman1,2, Gideon Koren7,2, Amalia Levy8,9. 1. Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva, 84105, Israel. 2. BeMORE Collaboration (Ben-Gurion Motherisk Obstetric Registry of Exposure Collaboration), Beer-Sheva, Israel. 3. Department of Pediatrics, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. 4. Soroka Medical Center, Beer-Sheva, Israel. 5. Clalit Health Services (Southern District), Beer-Sheva, Israel. 6. Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. 7. The Motherisk Program, Division of Clinical Pharmacology-Toxicology, Department of Pediatrics, The Hospital for Sick Children and The University of Toronto, Toronto, ON, Canada. 8. Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva, 84105, Israel. lamalia@bgu.ac.il. 9. BeMORE Collaboration (Ben-Gurion Motherisk Obstetric Registry of Exposure Collaboration), Beer-Sheva, Israel. lamalia@bgu.ac.il.
Abstract
INTRODUCTION: Enoxaparin is widely used during pregnancy as pregnancy is a hypercoagulable state; however, its fetal safety has scarcely been investigated. OBJECTIVE: Our study aimed to examine fetal safety following enoxaparin exposure during pregnancy. METHODS: A population-based, retrospective cohort study was performed by linking computerized databases, including the drug dispensing registries of Clalit Health Services in Israel and maternal and infant hospital records, between 1998 and 2009. Multivariate logistic regression models were used to examine associations between first- and third-trimester exposure to enoxaparin, major malformations, and other adverse birth outcomes, adjusted for confounders. RESULTS: From a total of 109,473 singleton pregnancies, 418 and 572 were exposed to enoxaparin during the first and third trimesters, respectively. Exposure to enoxaparin during the first trimester of pregnancy was not associated with an increased risk of major congenital malformations [adjusted odds ratio (aOR) 1.1, 95% confidence interval (CI) 0.8-1.6], while exposure during the third trimester was not associated with an increased risk of low birth weight (aOR 1.1, 95% CI 0.8-1.4), low Apgar score (aOR 0.9, 95% CI 0.4-1.8), or risk of perinatal mortality (aOR 0.6, 95% CI 0.1-2.9). CONCLUSION: Exposure to enoxaparin during pregnancy was not associated with an increased risk of major malformations in general or according to organ systems. Nonetheless, risk for specific malformations cannot be ruled out.
INTRODUCTION:Enoxaparin is widely used during pregnancy as pregnancy is a hypercoagulable state; however, its fetal safety has scarcely been investigated. OBJECTIVE: Our study aimed to examine fetal safety following enoxaparin exposure during pregnancy. METHODS: A population-based, retrospective cohort study was performed by linking computerized databases, including the drug dispensing registries of Clalit Health Services in Israel and maternal and infant hospital records, between 1998 and 2009. Multivariate logistic regression models were used to examine associations between first- and third-trimester exposure to enoxaparin, major malformations, and other adverse birth outcomes, adjusted for confounders. RESULTS: From a total of 109,473 singleton pregnancies, 418 and 572 were exposed to enoxaparin during the first and third trimesters, respectively. Exposure to enoxaparin during the first trimester of pregnancy was not associated with an increased risk of major congenital malformations [adjusted odds ratio (aOR) 1.1, 95% confidence interval (CI) 0.8-1.6], while exposure during the third trimester was not associated with an increased risk of low birth weight (aOR 1.1, 95% CI 0.8-1.4), low Apgar score (aOR 0.9, 95% CI 0.4-1.8), or risk of perinatal mortality (aOR 0.6, 95% CI 0.1-2.9). CONCLUSION: Exposure to enoxaparin during pregnancy was not associated with an increased risk of major malformations in general or according to organ systems. Nonetheless, risk for specific malformations cannot be ruled out.
Authors: J Lepercq; J Conard; A Borel-Derlon; J Y Darmon; O Boudignat; C Francoual; P Priollet; C Cohen; N Yvelin; J F Schved; M Tournaire; J Y Borg Journal: BJOG Date: 2001-11 Impact factor: 6.531