OBJECTIVE: To compare low molecular weight heparin (LMWH), specifically dalteparin, to unfractionated heparin (UFH) for the treatment of antiphospholipid antibody syndrome (APS) in pregnancy. METHODS: In a tertiary referral centre, 28 women met the 1999 International Consensus Criteria for APS, based on their obstetrical history and APS serology. The women were randomized, using a random numbers table with blocks of 12, to receive either prophylactic dosing of dalteparin or UFH starting either preconceptionally or early in pregnancy. All women also received low-dose acetylsalicylic acid, started preconceptionally. The primary outcome was a live birth. The secondary outcomes were maternal and fetal complications. RESULTS: Of the 14 women who received theLMWH, dalteparin, and the 14 women who received UFH, 1 woman in each group did not conceive. Nine of the 13 women (69%) given dalteparin had a successful pregnancy (95% confidence interval [CI], 39-91%), compared to 4 out of the 13 women (31%) in the UFH group (95% CI, 9-61%). Nine women in total had spinal or epidural anaesthesia, and there were no complications overall. CONCLUSION:Dalteparin may be an effective alternative to UFH for treatment of APS in pregnancy. A multicentre randomized trial is needed to determine benefit-to-risk ratios for the use of dalteparin and UFH to treat this high-risk obstetrical condition. Pharmacokinetic and pharmacodynamic studies are also recommended to maximize therapeutic response and minimize toxicity.
RCT Entities:
OBJECTIVE: To compare low molecular weight heparin (LMWH), specifically dalteparin, to unfractionated heparin (UFH) for the treatment of antiphospholipid antibody syndrome (APS) in pregnancy. METHODS: In a tertiary referral centre, 28 women met the 1999 International Consensus Criteria for APS, based on their obstetrical history and APS serology. The women were randomized, using a random numbers table with blocks of 12, to receive either prophylactic dosing of dalteparin or UFH starting either preconceptionally or early in pregnancy. All women also received low-dose acetylsalicylic acid, started preconceptionally. The primary outcome was a live birth. The secondary outcomes were maternal and fetal complications. RESULTS: Of the 14 women who received the LMWH, dalteparin, and the 14 women who received UFH, 1 woman in each group did not conceive. Nine of the 13 women (69%) given dalteparin had a successful pregnancy (95% confidence interval [CI], 39-91%), compared to 4 out of the 13 women (31%) in the UFH group (95% CI, 9-61%). Nine women in total had spinal or epidural anaesthesia, and there were no complications overall. CONCLUSION:Dalteparin may be an effective alternative to UFH for treatment of APS in pregnancy. A multicentre randomized trial is needed to determine benefit-to-risk ratios for the use of dalteparin and UFH to treat this high-risk obstetrical condition. Pharmacokinetic and pharmacodynamic studies are also recommended to maximize therapeutic response and minimize toxicity.
Authors: Shannon M Bates; Ian A Greer; Saskia Middeldorp; David L Veenstra; Anne-Marie Prabulos; Per Olav Vandvik Journal: Chest Date: 2012-02 Impact factor: 9.410
Authors: Fosca A F Di Prima; Oriana Valenti; Entela Hyseni; Elsa Giorgio; Marianna Faraci; Eliana Renda; Roberta De Domenico; Santo Monte Journal: J Prenat Med Date: 2011-04
Authors: Esme V Menezes; Mohammad Yawar Yakoob; Tanya Soomro; Rachel A Haws; Gary L Darmstadt; Zulfiqar A Bhutta Journal: BMC Pregnancy Childbirth Date: 2009-05-07 Impact factor: 3.007
Authors: Maristella D'Uva; Pierpaolo Di Micco; Ida Strina; Antonio Ranieri; Carlo Alviggi; Antonio Mollo; Francesca Fabozzi; Lucia Cacciapuoti; Maria Teresa Scotto di Frega; Mariateresa Iannuzzo; Giuseppe De Placido Journal: Biologics Date: 2008-12