NCT01321788

Brief Summary

Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It 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 occurs during the six weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 6, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

March 22, 2011

Last Update Submit

February 3, 2012

Conditions

BleedingVenous Thromboembolism

Keywords

thromboprophylaxispregnancypost-cesarian section

Outcome Measures

Primary Outcomes (1)

  • Deep Vein Thrombosis

    The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.

    24 months

Secondary Outcomes (1)

  • symptomatic DVT and bleeding

    Symptomatic DVT

Study Arms (2)

STUDY GROUP

will receive the study drug Innohep ® for 14 days

Drug: TINZAPARIN

CONTROL

The group that will receive placebo for 14 days

Drug: PLACEBO

Interventions

TINZAPARINDRUG

Eligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.

Also known as: Innohep
STUDY GROUP
PLACEBODRUG

Eligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.

CONTROL

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adult patients (aged over 18 years) that had been delivered by emergency or elective cesarean section with no previous history of VTE are eligible for the study.

You may qualify if:

  • Age \> 18 years old.
  • Delivered by cesarean section (emergency or planned).
  • Signed, informed consent.
  • Ready access to a local health service.
  • Capable of using Tinzaparin.

You may not qualify if:

  • at high risk for thromboembolism (any one of the following):
  • age more than 35 years old
  • obesity (more than 80 kg)
  • parity more than 4
  • gross varicose veins
  • current infection
  • pre-eclampsia
  • immobility prior to surgery (more than 4 days)
  • Major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome.
  • Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)
  • Patients with a family history of VTE
  • History of superficial phlebitis
  • More than 36 hours since delivery
  • Need for anticoagulation, including:
  • women with a confirmed thrombophilia
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Security Forces Hospital

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

Related Publications (5)

  • Kujovich JL. Hormones and pregnancy: thromboembolic risks for women. Br J Haematol. 2004 Aug;126(4):443-54. doi: 10.1111/j.1365-2141.2004.05041.x.

    PMID: 15287937BACKGROUND

  • Samuelsson E, Hellgren M, Hogberg U. Pregnancy-related deaths due to pulmonary embolism in Sweden. Acta Obstet Gynecol Scand. 2007;86(4):435-43. doi: 10.1080/00016340701207500.

    PMID: 17486465BACKGROUND

  • Morris JM, Algert CS, Roberts CL. Incidence and risk factors for pulmonary embolism in the postpartum period. J Thromb Haemost. 2010 May;8(5):998-1003. doi: 10.1111/j.1538-7836.2010.03794.x. Epub 2010 Feb 1.

    PMID: 20128859BACKGROUND

  • Chan WS. Venous thromboembolism in pregnancy. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1731-40. doi: 10.1586/erc.10.169.

    PMID: 21108555BACKGROUND

  • 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

Related Links

MeSH Terms

Conditions

HemorrhageVenous Thromboembolism

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • FARJAH H ALGAHTANI, MD

    King Saud University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FARJAH H ALGAHTANI, MD

CONTACT

0505805919falgahtani@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 24, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 6, 2012

Record last verified: 2012-02

Locations

SA(1)