Evaluation of the LMWH Thromboprophylaxis in Pregnancy
The project aims to clarify the effect of the thromboprophylactic LMWH dose on coagulation in pregnant women just before birth, at the period of maximal physiological hypercoagulable state and with high risk of thromboembolism, the most common cause of maternal mortality in developed countries. Although LMWH are now routinely administered as prevention of thromboembolism, their effect on coagulation in pregnant women was not yet studied. The doses of LMWH in pregnancy are only derived in terms of coagulation from totally different groups of patients (surgical, orthopedic). We therefore will map the effect of thromboprophylactic LMWH dose on coagulation in pregnant women using recently available methods, especially a complex examination of coagulation within 24 h after LMWH application using thrombelastography, including examination with heparinase, and monitoring the effect of LMWH by measuring antiXa and TGT (thrombin generation time) activity. Based on these results we will also evaluate the possible influence of LMWH prophylaxis on the risk of spinal haematoma during neuraxial analgesia/anesthesia for delivery/Caesarean section. On the basis of our pilot results we can presume the current dosage of LMWH in pregnant women is inadequate and that it would be appropriate to adjust presently used dosage. At the same time we want to prove that the standard LMWH thromboprophylaxis in pregnant women does not increase the risk of spinal haematoma during neuraxial blockade. In both situations the targeted outcome is to increase the safety of pregnant women.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Evaluation of the Impact of the Thromboprophylactic Dose of LMWH on Coagulation in Pregnant Women.|
- Effect of standard prophylactic dose of LMWH on coagulation in pregnant women [ Time Frame: 24 hours after LMWH application ] [ Designated as safety issue: No ]To map the coagulation effect of standard prophylactic dose of LMWH in pregnant women at the end of pregnancy. Based on these results, to evaluate the possible prophylactic effect of LMWH on TED prevention in pregnant compared to non-pregnant women.
- Evaluation of the possible influence of LMWH on the potential risk of spinal hematoma development during neuraxial blockade in pregnancy. [ Time Frame: 24 hours after LMWH application ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
whole blood, serum
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
50 pregnant women with physiological ongoing pregnancy and undergoing planned caesarean section, without known coagulation disorders, will be included in to the study.
Inclusion criteria: pregnant women undergoing planned caesarean section, 39th-40th week of pregnancy, age 18-40 years, informed consent.
50 healthy women in fertility age (18-40 years) undergoing elective surgery for other than oncology or inflammatory indication, without known risk factors for coagulation disorders, not using hormonal contraception, informed consent.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01394107
|Contact: Jan Blaha, md, PhD||+420 firstname.lastname@example.org|
|General University Hospital in Prague||Recruiting|
|Prague 2, Czech Republic, 128 08|
|Contact: Jan Blaha, MD, PhD +420 224947241|
|Principal Investigator: Jan Blaha, MD, PhD|
|Principal Investigator:||Jan Blaha, MD, PhD||Charles University, 1st Medical Faculty in Prague|