ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612001094864

Ethics application status

Approved

Date submitted

12/10/2012

Date registered

12/10/2012

Date last updated

8/03/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Review of Management and Outcome of Women with Thrombophilia-Risk during Pregnancy at a Single Institution

Scientific title

Review of Management and Outcome of Women with Thrombophilia-Risk during Pregnancy at a Single Institution

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

VTE in Pregnancy

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Thrombophilia

Pregnancy

Condition category

Condition code

Blood

Haematological diseases

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

To study pregnant women at risk of thrombophilia who received anticoagulation therapy according to the Royal College of Obstetricians and Gynaecologists 2004 guidelines “Thromboprophylaxis During Pregnancy, Labour and after Vaginal Delivery” and compare their obstetric outcomes with a matched cohort of women without thrombophilia-risk.
The patients’ medical records will be reviewed by a trainee of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and supervised by senior Obstetricians. All patients were co-managed by a haematologist who assessed the patients and determined the need for anticoagulation and the appropriate anticoagulant and regimen as per the Royal College of Obstetricians and Gynaecologists 2004 guidelines “Thromboprophylaxis During Pregnancy, Labour and after Vaginal Delivery” and its subsequent edition in 2009 “Green-top Guideline 37a”. The data will be collected from January 2007 to December 2010.

Intervention code [1]

Not applicable

Comparator / control treatment

pregnant women without thrombophilia risk during the same period at the same institution.

Control group

Active

Outcomes

Primary outcome [1]

To study pregnant women at risk of thrombophilia who received anticoagulation therapy according to the Royal College of Obstetricians and Gynaecologists 2004 guidelines Thromboprophylaxis During Pregnancy, Labour and after Vaginal Delivery and compare their obstetric outcomes with a matched cohort of women without thrombophilia-risk.

An assessment form was designed and used to collect medical, obstetric, and family history for each patient as well as risk factors for thrombosis and previous VTE. Outcomes of previous and current pregnancies were also recorded.

Timepoint [1]

at the end of the study.

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Pregnant women above the age of 18, that having risk for developing thrmboembolic events and underwent anticoagulation therapy during their pregnancy.

Minimum age

No limit

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

non-pregnant females are excluded and pregnant women without any thrombophilia-risk are not eligible as well.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/09/2009

Actual

15/01/2007

Date of last participant enrolment

Anticipated

Actual

31/12/2010

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Launceston General Hospital

Address [1]

Charles Street,
Launceston, 7250
Tasmania

Country [1]

Australia

Primary sponsor type

Hospital

Name

Launceston General Hospital

Address

Charles Street,
Launceston, 7250
Tasmania

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmania State wide Human Ethics Committee

Ethics committee address [1]

University of Tasmania
Private Bag 01
Hobart TAS 7001

Web: http://www.research.utas.edu.au/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/06/2009

Ethics approval number [1]

H0010651

Summary

Brief summary

Pregnancy is associated with major physiological changes that affect coagulation and fibrinolytic system.  An imbalance to this system leads to a hypercoaguable state and pregnant women are therefore at an increased risk of venous thromboembolic disease (VTE), especially if they are affected by an associated acquired or inherited thrombophilia. There are two factors that may exaggerate this risk; the high-risk nature of the thrombophilia and a history of a previous unprovoked VTE.  High-risk hereditary thrombophilia include antithrombin deficiency, prothrombin gene mutation (PGM), and factor V leiden (FVL), while the presence of lupus anticoagulant or anticardiolipin antibodies are considered as acquired risk factors. Furthermore, homozygosity or presence of a combination of thrombophilia factors will aggravate the VTE-risk by certain fold increase.
Apart from the occurrence of VTE, maternal thrombophilia has also been variably associated with an increased risk of early miscarriages, intrauterine growth restriction (IUGR), and pregnancy loss. 
Although it may seem intuitive to treat pregnant women with high-risk thrombophilia with anticoagulant prophylactically, there is a paucity of randomised trials in this area, and the balance of intervention versus conservative management should be carefully evaluated from both fetal and maternal point of view. Evidence-based guidelines have been published in an attempt to provide a more uniform clinical approach; however there appears to be a lack of consistency among different guidelines.
The decision to recommend anticoagulant prophylaxis to women with thrombophilia is based on the risk-assessment or balance of bleeding versus VTE-risk as well as the potential effects of VTE and anticoagulant can have on pregnancy. However, the use of anticoagulant in pregnancy is challenging because of the potential for maternal and fetal complications. Despite this and the lack of controlled trials, there has been increased use of anticoagulants to prevent VTE and adverse pregnancy outcomes. 
In this retrospective/prospective study, the management strategies of women with high risk for thrombophilia who received antenatal care at a single institution during the period between Jan 2007 and December 2010 were reviewed and analysed.

Trial website

Trial related presentations / publications

Khalafallah AA, Ibraheem AR, Teo QY, Albarzan AM, Parameswaran R, Hooper E, Pavlov T, Dennis AE, Hannan T. Review of Management and Outcomes in Women with Thrombophilia Risk during Pregnancy at a Single Institution.
ISRN Obstet Gynecol. 2014 Feb 17;2014:381826. doi: 10.1155/2014/381826. eCollection 2014.

www.ncbi.nlm.nih.gov/pubmed/24693443
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3945432/

Public notes

Contacts

Principal investigator

Name

Prof Professor Alhossain Khalafallah

Address

Launceston General Hospital
Charles Street
TAS
7250 Australia

Country

Australia

Phone

+61367776777

Fax

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

Professor Alhossain A. Khalafallah

Address

Launceston General Hospital Charles Street, Launceston, TAS 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

Contact person for scientific queries

Name

Professor Alhossain A. Khalafallah

Address

Launceston General Hospital Charles Street, Launceston, TAS 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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