Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S L Monte

ORCID ID

Contact details

Department of Obstetric Anaesthesia
Leeds Teaching Hospitals NHS Trust
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130319

Study information

Scientific title

A comparison of enoxaparin and tinzaparin as thromboprophylaxis during pregnancy

Acronym

Study hypothesis

Unpublished data prepared by our department has shown that pregnant women display some resistance to the use of low molecular weight heparins. We would like to compare the use of enoxaparin and tinzaparin in pregnant women who have a previous history of venous thromboembolism, or who have inherited of acquired condition which predisposes them to venous thromboprophylactic doses as recommended by the respective manufacturers and monitoring the effects by using anti factor Xa assays and thromboelastography.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Thromboembolism

Intervention

Randomised controlled trial.
Random allocation to receive:
1. Enoxaparin
2. Tinaparin

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

We propose to compare the coagulation profiles of enoxaparin and tinaparin. We will use TEG and anti Xa activity to monitor effects.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2001

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant patients with moderate risks of venous thromboembolism
2. Patients with history of recurrent miscarriage
3. Patients on low dose aspirin will be included as this has been shown not to adversely affect their TEG variables

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Subjects who have been admitted to hospital and are able to maintain their self catheterization regime
2. Subjects with symptomatic urinary tract infection, who are currently undergoing chemotherapy, radiation or steroid therapy, who self catheterize only once a day

Recruitment start date

01/08/2001

Recruitment end date

01/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
Department of Obstetric Anaesthesia
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator