PMID- 15307977 OWN - NLM STAT- MEDLINE DCOM- 20041116 LR - 20220331 IS - 1701-2163 (Print) IS - 1701-2163 (Linking) VI - 26 IP - 8 DP - 2004 Aug TI - Treatment of antiphospholipid antibody syndrome (APS) in pregnancy: a randomized pilot trial comparing low molecular weight heparin to unfractionated heparin. PG - 729-34 AB - 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. FAU - Stephenson, Mary D AU - Stephenson MD AD - Department of Obstetrics and Gynaecology, University of British Columbia,Vancouver. FAU - Ballem, Penny J AU - Ballem PJ FAU - Tsang, Peter AU - Tsang P FAU - Purkiss, Sue AU - Purkiss S FAU - Ensworth, Stephanie AU - Ensworth S FAU - Houlihan, Edwina AU - Houlihan E FAU - Ensom, Mary H H AU - Ensom MH LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - Netherlands TA - J Obstet Gynaecol Can JT - Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC JID - 101126664 RN - 0 (Anticoagulants) RN - 9005-49-6 (Heparin) RN - R16CO5Y76E (Aspirin) RN - S79O08V79F (Dalteparin) SB - IM MH - Adult MH - Anticoagulants/*therapeutic use MH - Antiphospholipid Syndrome/*drug therapy MH - Aspirin/therapeutic use MH - Dalteparin/*therapeutic use MH - Female MH - Heparin/*therapeutic use MH - Humans MH - Pilot Projects MH - Preconception Care MH - Pregnancy MH - Pregnancy Complications/*drug therapy MH - Pregnancy Outcome EDAT- 2004/08/17 10:00 MHDA- 2004/11/17 09:00 CRDT- 2004/08/17 10:00 PHST- 2004/08/17 10:00 [pubmed] PHST- 2004/11/17 09:00 [medline] PHST- 2004/08/17 10:00 [entrez] AID - S1701-2163(16)30644-2 [pii] AID - 10.1016/s1701-2163(16)30644-2 [doi] PST - ppublish SO - J Obstet Gynaecol Can. 2004 Aug;26(8):729-34. doi: 10.1016/s1701-2163(16)30644-2.