Evaluation of the LMWH Thromboprophylaxis in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Charles University, Czech Republic
Sponsor:
Information provided by (Responsible Party):
Jan Blaha, MD, PhD., Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01394107
First received: July 13, 2011
Last updated: October 9, 2013
Last verified: October 2013
  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.


Condition
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.

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • 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.


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 ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  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
Study Population

pregnant women undergoing planned caesarean section, 39th-40th week of pregnancy, age 18-40 years

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394107

Contacts
Contact: Jan Blaha, md, PhD +420 224967241 jan.blaha@lf1.cuni.cz

Locations
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         
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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: October 9, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
Thromboprophylaxis
Effect of LMWH on coagulation
Pregnancy
Neuraxial anesthesia
Spinal haematoma

ClinicalTrials.gov processed this record on September 30, 2014