NCT00225108

Brief Summary

Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT refers to a blood clot that has formed in a deep vein, often in the legs and/or pelvis and PE refers to the passage of these clots into the lungs (which can be fatal). VTE is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy related VTE occur during the 6 weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold. A medication called low molecular weight heparin is sometimes prescribed during pregnancy and after delivery to prevent VTE. However, clinical practice varies because there hasn't been adequate research to determine that this medication is safe and effective at preventing VTE during this time. The potential benefits of the medication must also be weighed against its cost and possible side effects. The researchers are conducting a study that will assess the effectiveness and safety of low molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean section. They will monitor these women to determine if those who received the medication have fewer blood clots. Participants will also be monitored closely for any side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

First QC Date

September 21, 2005

Last Update Submit

February 5, 2018

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosisbleeding

Outcome Measures

Primary Outcomes (1)

  • VTE on magnetic resonance venography (MRV) or bilateral leg Doppler ultrasound

Interventions

TinzaparinDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At high risk for thromboembolism (any one of the following):
  • Age \> 35 years
  • Obesity (\> 80 kg)
  • Para \4
  • Gross varicose veins
  • Current infection
  • Pre-eclampsia
  • Immobility prior to surgery (\> 4 days)
  • Major current disease: includes heart or lung disease, cancer, inflammatory bowel disease, and nephrotic syndrome.
  • Emergency cesarean section in labour
  • Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)
  • Patients with a family history of VTE
  • History of superficial phlebitis
  • Delivered by cesarean section (emergency or planned)
  • Signed, informed consent

You may not qualify if:

  • Greater than 36 hours since delivery
  • Need for anticoagulation, including:
  • Women with a confirmed thrombophilia
  • Women with paralysis of lower limbs
  • Women with personal history of VTE
  • Women with antiphospholipid antibody syndrome (APLA)
  • Women with mechanical heart valves
  • Contraindication to heparin therapy, including:
  • History of heparin induced thrombocytopenia
  • Platelet count of less than 100,000 x 10\^6/L
  • Hemoglobin \<= 90 g/L or a greater than 30 g/L drop in hemoglobin compared to last antepartum result
  • History of osteoporosis
  • History of steroid use (one week or more)
  • Active bleeding
  • Documented peptic ulcer within 6 weeks
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (2)

  • Rodger MA, Avruch LI, Howley HE, Olivier A, Walker MC. Pelvic magnetic resonance venography reveals high rate of pelvic vein thrombosis after cesarean section. Am J Obstet Gynecol. 2006 Feb;194(2):436-7. doi: 10.1016/j.ajog.2005.07.044.

    PMID: 16458642RESULT

  • Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.

    PMID: 33779986DERIVED

MeSH Terms

Conditions

Venous ThrombosisHemorrhage

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Marc Rodger, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

July 1, 2002

Study Completion

September 1, 2006

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

CA(1)