Evaluation of the LMWH Thromboprophylaxis in Pregnancy
Verified July 2015 by Charles University, Czech Republic
Information provided by (Responsible Party):
Jan Blaha, MD, PhD., Charles University, Czech Republic
First received: July 13, 2011
Last updated: July 27, 2015
Last verified: July 2015
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Evaluation of the Impact of the Thromboprophylactic Dose of LMWH on Coagulation in Pregnant Women.
Primary Outcome Measures:
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- 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 ]
whole blood, serum
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 40 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
pregnant women undergoing planned caesarean section, 39th-40th week of pregnancy, age 18-40 years
- pregnant women undergoing planned caesarean section
- 39th-40th week of pregnancy
- age 18-40 years
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01394107
|General University Hospital in Prague
|Prague 2, Czech Republic, 128 08 |
|Contact: Jan Blaha, MD, PhD +420 224947241 |
|Principal Investigator: Jan Blaha, MD, PhD |
Charles University, Czech Republic
||Jan Blaha, MD, PhD
||Charles University, 1st Medical Faculty in Prague
||Jan Blaha, MD, PhD., M.D., PhD., Charles University, Czech Republic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 13, 2011
||July 27, 2015
||Czech Republic: Ethics Committee
Keywords provided by Charles University, Czech Republic:
ClinicalTrials.gov processed this record on July 28, 2016
Effect of LMWH on coagulation