A comparison of enoxaparin and tinzaparin as thromboprophylaxis during pregnancy

ISRCTN	ISRCTN65511274
DOI	https://doi.org/10.1186/ISRCTN65511274
Secondary identifying numbers	N0436130319

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Dr S L Monte
Scientific

Department of Obstetric Anaesthesia
Leeds Teaching Hospitals NHS Trust
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)113 243 3144
Email	r&d@leedsth.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title	A comparison of enoxaparin and tinzaparin as thromboprophylaxis during pregnancy
Study hypothesis	Unpublished data prepared by our department has shown that pregnant women display some resistance to the use of low molecular weight heparins.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(s)	Not provided at time of registration
Condition	Thromboembolism
Intervention	Randomised controlled trial. Random allocation to receive: 1. Enoxaparin 2. Tinaparin
Intervention type	Other
Primary outcome measure	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 study start date	01/08/2001
Overall study end date	01/08/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	200
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 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

Leeds Teaching Hospitals NHS Trust

Department of Obstetric Anaesthesia
Leeds
LS9 7TF
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Leeds Teaching Hospitals NHS Trust

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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