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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

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 t... Full description

Journal Title: Lancet November 8, 2014, Vol.384(9955), pp.1673-1683
Main Author: Rodger, Marc A
Other Authors: Hague, William M , Kingdom, John , Kahn, Susan R , Karovitch, Alan , Sermer, Mathew , Clement, Anne Marie , Coat, Suzette , Chan, Wee Shian , Said, Joanne , Rey, Evelyne , Robinson, Sue , Khurana, Rshmi , Demers, Christine , Kovacs, Michael J , Solymoss, Susan , Hinshaw, Kim , Dwyer, James , Smith, Graeme , Mcdonald, Sarah , Newstead-Angel, Jill , Mcleod, Anne , Khandelwal, Meena , Silver, Robert M , Le Gal, Gregoire , Greer, Ian A , Keely, Erin , Rosene-Montella, Karen , Walker, Mark , Wells, Philip S
Format: Electronic Article Electronic Article
Language: English
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ID: ISSN: 0140-6736
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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
format: Article
creator:
  • Rodger, Marc A
  • Hague, William M
  • Kingdom, John
  • Kahn, Susan R
  • Karovitch, Alan
  • Sermer, Mathew
  • Clement, Anne Marie
  • Coat, Suzette
  • Chan, Wee Shian
  • Said, Joanne
  • Rey, Evelyne
  • Robinson, Sue
  • Khurana, Rshmi
  • Demers, Christine
  • Kovacs, Michael J
  • Solymoss, Susan
  • Hinshaw, Kim
  • Dwyer, James
  • Smith, Graeme
  • Mcdonald, Sarah
  • Newstead-Angel, Jill
  • Mcleod, Anne
  • Khandelwal, Meena
  • Silver, Robert M
  • Le Gal, Gregoire
  • Greer, Ian A
  • Keely, Erin
  • Rosene-Montella, Karen
  • Walker, Mark
  • Wells, Philip S
subjects:
  • Randomised Controlled Trial
  • Quantitative Research
  • Pregnancy : Complications
  • Thrombosis
  • Drug Therapy
  • Abortion : Spontaneous
  • Miscarriage
  • Pregnancy
  • Pregnancy Complications
  • Clinical Trials
  • Canada
  • Australia
  • France
  • United States–Us
  • United Kingdom–UK
ispartof: Lancet, November 8, 2014, Vol.384(9955), pp.1673-1683
description: 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
language: eng
source:
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 01406736
  • 0140-6736
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titleAntepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial
creatorRodger, Marc A ; Hague, William M ; Kingdom, John ; Kahn, Susan R ; Karovitch, Alan ; Sermer, Mathew ; Clement, Anne Marie ; Coat, Suzette ; Chan, Wee Shian ; Said, Joanne ; Rey, Evelyne ; Robinson, Sue ; Khurana, Rshmi ; Demers, Christine ; Kovacs, Michael J ; Solymoss, Susan ; Hinshaw, Kim ; Dwyer, James ; Smith, Graeme ; Mcdonald, Sarah ; Newstead-Angel, Jill ; Mcleod, Anne ; Khandelwal, Meena ; Silver, Robert M ; Le Gal, Gregoire ; Greer, Ian A ; Keely, Erin ; Rosene-Montella, Karen ; Walker, Mark ; Wells, Philip S
ispartofLancet, November 8, 2014, Vol.384(9955), pp.1673-1683
identifierISSN: 0140-6736
subjectRandomised Controlled Trial ; Quantitative Research ; Pregnancy : Complications ; Thrombosis ; Drug Therapy ; Abortion : Spontaneous ; Miscarriage ; Pregnancy ; Pregnancy Complications ; Clinical Trials ; Canada ; Australia ; France ; United States–Us ; United Kingdom–UK
descriptionThrombophilias 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 withClinicalTrials.gov, numberNCT00967382, 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%]vsno 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%]vsno 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. 45 references
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8Chan, Wee Shian
9Said, Joanne
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13Demers, Christine
14Kovacs, Michael J
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16Hinshaw, Kim
17Dwyer, James
18Smith, Graeme
19Mcdonald, Sarah
20Newstead-Angel, Jill
21Mcleod, Anne
22Khandelwal, Meena
23Silver, Robert M
24Le Gal, Gregoire
25Greer, Ian A
26Keely, Erin
27Rosene-Montella, Karen
28Walker, Mark
29Wells, Philip S
titleAntepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial
descriptionThrombophilias 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 withClinicalTrials.gov, numberNCT00967382, 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%]vsno 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%]vsno 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. 45 references
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titleAntepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial
authorRodger, Marc A ; Hague, William M ; Kingdom, John ; Kahn, Susan R ; Karovitch, Alan ; Sermer, Mathew ; Clement, Anne Marie ; Coat, Suzette ; Chan, Wee Shian ; Said, Joanne ; Rey, Evelyne ; Robinson, Sue ; Khurana, Rshmi ; Demers, Christine ; Kovacs, Michael J ; Solymoss, Susan ; Hinshaw, Kim ; Dwyer, James ; Smith, Graeme ; Mcdonald, Sarah ; Newstead-Angel, Jill ; Mcleod, Anne ; Khandelwal, Meena ; Silver, Robert M ; Le Gal, Gregoire ; Greer, Ian A ; Keely, Erin ; Rosene-Montella, Karen ; Walker, Mark ; Wells, Philip S
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1Quantitative Research
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3Thrombosis
4Drug Therapy
5Abortion : Spontaneous
6Miscarriage
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8Pregnancy Complications
9Clinical Trials
10Canada
11Australia
12France
13United States–Us
14United Kingdom–UK
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1Hague, William M
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7Coat, Suzette
8Chan, Wee Shian
9Said, Joanne
10Rey, Evelyne
11Robinson, Sue
12Khurana, Rshmi
13Demers, Christine
14Kovacs, Michael J
15Solymoss, Susan
16Hinshaw, Kim
17Dwyer, James
18Smith, Graeme
19Mcdonald, Sarah
20Newstead-Angel, Jill
21Mcleod, Anne
22Khandelwal, Meena
23Silver, Robert M
24Le Gal, Gregoire
25Greer, Ian A
26Keely, Erin
27Rosene-Montella, Karen
28Walker, Mark
29Wells, Philip S
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1Hague, William M
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8Chan, Wee Shian
9Said, Joanne
10Rey, Evelyne
11Robinson, Sue
12Khurana, Rshmi
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14Kovacs, Michael J
15Solymoss, Susan
16Hinshaw, Kim
17Dwyer, James
18Smith, Graeme
19Mcdonald, Sarah
20Newstead-Angel, Jill
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25Greer, Ian A
26Keely, Erin
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28Walker, Mark
29Wells, Philip S
atitleAntepartum 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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abstractThrombophilias 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 withClinicalTrials.gov, numberNCT00967382, 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%]vsno 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%]vsno 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. 45 references
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doi10.1016/S0140-6736(14)60793-5
eissn1474547X
date2014-11-08