Evaluation of the LMWH Thromboprophylaxis in Pregnancy

NCT01394107 | Completed

• 1 other identifier: LMWH_jB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Thromboprophylaxis; Effect of LMWH on coagulation; Pregnancy; Neuraxial anesthesia; Spinal haematoma

Outcome Measures

Primary Outcomes (1)

• Effect of standard prophylactic dose of LMWH on coagulation in pregnant women

  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.

  24 hours after LMWH application

Secondary Outcomes (1)

• Evaluation of the possible influence of LMWH on the potential risk of spinal hematoma development during neuraxial blockade in pregnancy.

  24 hours after LMWH application

Study Arms (2)

Pregnant

20 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

20 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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator

Study Sites (1)

General University Hospital in Prague

Prague, 128 08, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum

Study Officials

• Jan Blaha, MD, PhD

  Charles University, 1st Medical Faculty in Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD.

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 14, 2011
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: October 30, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CZ (1)