Evaluation of the LMWH Thromboprophylaxis in Pregnancy
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Purpose
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.
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Pregnancy |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Pregnant
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. |
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Control
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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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
pregnant women undergoing planned caesarean section, 39th-40th week of pregnancy, age 18-40 years
Inclusion Criteria:
- pregnant women undergoing planned caesarean section
- 39th-40th week of pregnancy
- age 18-40 years
Exclusion Criteria:
- disapproval or non-cooperation of the mother
- allergy to LMWH
- coagulation disorders or the risk of
- anticoagulant therapy in the last 3 months
- signs of infection
- history of cancer
- signs of thrombosis or a history of thrombosis
- the ongoing non-physiological pregnancy
- significant obesity, or other severe comorbidity
Contacts and Locations| Contact: Jan Blaha, md, PhD | +420 224967241 | jan.blaha@lf1.cuni.cz |
| Czech Republic | |
| 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 |
More Information
No publications provided
| Responsible Party: | Jan Blaha, MD, PhD., M.D., PhD., Charles University, Czech Republic |
| ClinicalTrials.gov Identifier: | NCT01394107 History of Changes |
| Other Study ID Numbers: | LMWH_jB |
| Study First Received: | July 13, 2011 |
| Last Updated: | April 6, 2013 |
| Health Authority: | Czech Republic: Ethics Committee |
Keywords provided by Charles University, Czech Republic:
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Thromboprophylaxis Effect of LMWH on coagulation Pregnancy Neuraxial anesthesia Spinal haematoma |
ClinicalTrials.gov processed this record on May 19, 2013