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Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial

The Lancet (British edition), 2014-11, Vol.384 (9955), p.1673-1683 [Peer Reviewed Journal]

Elsevier Ltd ;2015 INIST-CNRS ;Copyright © 2014 Elsevier Ltd. All rights reserved. ;Copyright Elsevier Limited Nov 8, 2014 ;Distributed under a Creative Commons Attribution 4.0 International License ;ISSN: 0140-6736 ;EISSN: 1474-547X ;DOI: 10.1016/S0140-6736(14)60793-5 ;PMID: 25066248 ;CODEN: LANCAO

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Title:
Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial
Author: Rodger, Marc A, Prof ; Hague, William M, Prof ; Kingdom, John, Prof ; Kahn, Susan R, Prof ; Karovitch, Alan, MD ; Sermer, Mathew, Prof ; Clement, Anne Marie, RN ; Coat, Suzette, PhD ; Chan, Wee Shian, MD ; Said, Joanne, MBBS ; Rey, Evelyne, MD ; Robinson, Sue, Prof ; Khurana, Rshmi, MD ; Demers, Christine, MD ; Kovacs, Michael J, Prof ; Solymoss, Susan, MD ; Hinshaw, Kim, MBBS ; Dwyer, James, MBBS ; Smith, Graeme, Prof ; McDonald, Sarah, MD ; Newstead-Angel, Jill, MD ; McLeod, Anne, MD ; Khandelwal, Meena, Prof ; Silver, Robert M, Prof ; Le Gal, Gregoire, Prof ; Greer, Ian A, Prof ; Keely, Erin, Prof ; Rosene-Montella, Karen, Prof ; Walker, Mark, MD ; Wells, Philip S, Prof
Subjects: Adult ; Age ; Anticoagulants ; Biological and medical sciences ; Dalteparin - adverse effects ; Dalteparin - therapeutic use ; Drug dosages ; Drug therapy ; Female ; Fibrinolytic Agents - adverse effects ; Fibrinolytic Agents - therapeutic use ; General aspects ; Gynecology and obstetrics ; Hematologic and hematopoietic diseases ; Hematology ; Hemorrhage - chemically induced ; Human health and pathology ; Humans ; Internal Medicine ; Life Sciences ; Medical sciences ; Mortality ; Placenta ; Platelet diseases and coagulopathies ; Preeclampsia ; Pregnancy ; Pregnancy Complications, Cardiovascular - prevention & control ; Pregnancy Outcome - epidemiology ; Prevention and actions ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Risk Factors ; Thrombophilia - complications ; Thrombophilia - drug therapy ; Thrombosis ; Treatment Outcome ; Venous Thromboembolism - prevention & control
Is Part Of: The Lancet (British edition), 2014-11, Vol.384 (9955), p.1673-1683
Description: Summary Background Thrombophilias are common disorders that increase the risk of pregnancy-associated venous thromboembolism and pregnancy loss and can also increase the risk of placenta-mediated pregnancy complications (severe pre-eclampsia, small-for-gestational-age infants, and placental abruption). We postulated that antepartum dalteparin would reduce these complications in pregnant women with thrombophilia. Methods In this open-label randomised trial undertaken in 36 tertiary care centres in five countries, we enrolled consenting pregnant women with thrombophilia at increased risk of venous thromboembolism or with previous placenta-mediated pregnancy complications. Eligible participants were randomly allocated in a 1:1 ratio to either antepartum prophylactic dose dalteparin (5000 international units once daily up to 20 weeks' gestation, and twice daily thereafter until at least 37 weeks' gestation) or to no antepartum dalteparin (control group). Randomisation was done by a web-based randomisation system, and was stratified by country and gestational age at randomisation day with a permuted block design (block sizes 4 and 8). At randomisation, site pharmacists (or delegates) received a randomisation number and treatment allocation (by fax and/or e-mail) from the central web randomisation system and then dispensed study drug to the local coordinator. Patients and study personnel were not masked to treatment assignment, but the outcome adjudicators were masked. The primary composite outcome was independently adjudicated severe or early-onset pre-eclampsia, small-for-gestational-age infant (birthweight <10th percentile), pregnancy loss, or venous thromboembolism. We did intention-to-treat and on-treatment analyses. This trial is registered with ClinicalTrials.gov , number NCT00967382 , and with Current Controlled Trials, number ISRCTN87441504. Findings Between Feb 28, 2000, and Sept 14, 2012, 292 women consented to participate and were randomly assigned to the two groups. Three women were excluded after randomisation because of ineligibility (two in the antepartum dalteparin group and one in the control group), leaving 146 women assigned to antepartum dalteparin and 143 assigned to no antepartum dalteparin. Some patients crossed over to the other group during treatment, and therefore for on-treatment and safety analysis there were 143 patients in the dalteparin group and 141 in the no dalteparin group. Dalteparin did not reduce the incidence of the primary composite outcome in both intention-to-treat analysis (dalteparin 25/146 [17·1%; 95% CI 11·4–24·2%] vs no dalteparin 27/143 [18·9%; 95% CI 12·8–26·3%]; risk difference −1·8% [95% CI −10·6% to 7·1%)) and on-treatment analysis (dalteparin 28/143 [19·6%] vs no dalteparin 24/141 [17·0%]; risk difference +2·6% [95% CI −6·4 to 11·6%]). In safety analysis, the occurrence of major bleeding did not differ between the two groups. However, minor bleeding was more common in the dalteparin group (28/143 [19·6%]) than in the no dalteparin group (13/141 [9·2%]; risk difference 10·4%, 95% CI 2·3–18·4; p=0·01). Interpretation Antepartum prophylactic dalteparin does not reduce the occurrence of venous thromboembolism, pregnancy loss, or placenta-mediated pregnancy complications in pregnant women with thrombophilia at high risk of these complications and is associated with an increased risk of minor bleeding. Funding Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, and Pharmacia and UpJohn.
Publisher: Kidlington: Elsevier
Language: English
Identifier: ISSN: 0140-6736
EISSN: 1474-547X
DOI: 10.1016/S0140-6736(14)60793-5
PMID: 25066248
CODEN: LANCAO
Source: ProQuest One Psychology
MEDLINE
ProQuest Central

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Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial

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