“Even if I wish we had shown that LMWH prevents complications, actuallyà, we have shown that it does not help,” said the lead author, Marc A. Rogers, professor at the Facultyà of Medicine of the Università Ottawa, Ontario, Canada, in a statement. “However, I am very pleased that we can now spare these women all those unnecessary needles”.
adverse Outcomes of thrombophilia include venous thromboembolism associated with pregnancy, loss of pregnancy, severe pre-eclampsia, infants small for the età management and sudden detachment of the placenta. Even if the use of LMWH to treat pregnant women with thrombophilia became widespread in the ’90s, no experiment random multisite had ever been done to prove its effectiveness.
The purpose of this study was to see if dalteparin pre-birth would have lowered the percentage of these complications in pregnant women with thrombophilia.
Between 28 February 2000 and 14 September 2012, the researchers recruited 292 pregnant women with thrombophilia at high risk for venous thromboembolism or with previous complications from the pregnancy compared to the placenta, from 36 service centers are tertiary in 5 nations.
They randomly assigned the women 1:1 to receive LMWH ante-partum (dalteparin) (5000 IU once a day for up to 20 weeks of gestation, and twice a day after at least 37 weeks) or to a control group that did not receive deltaparin. The researchers excluded 3 women (2 in group deltaparin and 1 in the other) after randomization for inelegibilità. The judges of the result, but not the patients and the staff of the studio, they were unaware of the distribution of the treatment.
in the analysis, the intention of care in the analysis of care, the deltaparin has not reduced the incidence of the primary outcome composite (pre-eclampsia independently judged to be of a serious incident, a small child, for the età gestational, pregnancy loss, or venous thromboembolism).
“These findings allow us to move forward, to pursue other methods, potentially effective, for treating pregnant women with thrombophilia and/or complications from blood clots in the placenta,” said Dr. Rogers in the statement.
The safety analysis showed that the two groups did not differ in the occurrence of extensive bleeding, but that bleeding lower was the più comune in the group dalteparin (28/143 (19.6%)) than in the control group (13/141 (9.2%)); risk difference, 10.4%; ); 95% confidence interval, 2.3% – 18.4%; P=.01).
“The dalteparin prophylactic pre-partum does not reduce the occurrence of venous thromboembolism, loss of pregnancy, or complications of pregnancy related to the placenta in pregnant women with thrombophilia at high risk of these complications and is associated with an increased risk of bleeding from minor”, wrote the autorte of the study.
an editorial accompanying Paul S. Gibson, MD, of the Department of Medicine and the Department of Obstetrics and Gynecology, University of Calgary, Calgary, Alberta, and Kara A. Nerenberg, MD, of the Department of Medicine, University of Ottawa, Ontario, Canada, define TIPPS “methodologically rigorous”, but notice the limitations of the study of the low percentage of event (18.9% observed events compared to 49% advance in the control group), using the differential of aspirin among the study groups, slow percentage of recruitment and the small entityà of the subgroups.
TIPPS “show that (LMWH) is ineffective in preventing a large amount of important risuktati adverse pregnancy in women with thrombophilia,” writes the columnist. “Hopefully, these results dissuaderanno physicians from using the medication in this field and will motivate researchers to pursue other interventions potentially effective in the prevention of.”
The Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, and Pharmacia and UpJohn had funded this study. Some of the authors of the study have reported to have received support from the Heart and Stroke Foundation of Ontario, University of Ottawa, Fonds de la Recherche en Santé du Québec, the Canadian Institutes of Health Research, and/or Rose Torno Chair. One of the authors of the study received fees for the activities; educational from Leo Pharma, Sanofi, and Bayer. Dr. Gibson reported having received funding unlimited from Sanofi. Dr. Nerenberg has found no financial relationships relevant.
Lancet. Published online July 24, 2014
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