Trial Review

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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] 281386 0
nil
Universal Trial Number (UTN)
Trial acronym
VTE in Pregnancy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thrombophilia 287620 0
Pregnancy 287621 0
Condition category
Condition code
Blood 287949 287949 0 0
Haematological diseases
Reproductive Health and Childbirth 287950 287950 0 0
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] 285864 0
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] 288158 0
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] 288158 0
at the end of the study.
Secondary outcome [1] 299526 0
Nil
Timepoint [1] 299526 0
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?
No
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
40
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 286137 0
Hospital
Name [1] 286137 0
Launceston General Hospital
Country [1] 286137 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles Street,
Launceston, 7250
Tasmania
Country
Australia
Secondary sponsor category [1] 284949 0
None
Name [1] 284949 0
Address [1] 284949 0
Country [1] 284949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288189 0
Tasmania State wide Human Ethics Committee
Ethics committee address [1] 288189 0
University of Tasmania
Private Bag 01
Hobart TAS 7001

Web: http://www.research.utas.edu.au/
Ethics committee country [1] 288189 0
Australia
Date submitted for ethics approval [1] 288189 0
Approval date [1] 288189 0
23/06/2009
Ethics approval number [1] 288189 0
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 34824 0
Prof Professor Alhossain Khalafallah
Address 34824 0
Launceston General Hospital
Charles Street
TAS
7250 Australia
Country 34824 0
Australia
Phone 34824 0
+61367776777
Fax 34824 0
Email 34824 0
[email protected]
Contact person for public queries
Name 18071 0
Prof Professor Alhossain A. Khalafallah
Address 18071 0
Launceston General Hospital Charles Street, Launceston, TAS 7250
Country 18071 0
Australia
Phone 18071 0
+61373487111
Fax 18071 0
+61373487695
Email 18071 0
[email protected]
Contact person for scientific queries
Name 8999 0
Prof Professor Alhossain A. Khalafallah
Address 8999 0
Launceston General Hospital Charles Street, Launceston, TAS 7250
Country 8999 0
Australia
Phone 8999 0
+61373487111
Fax 8999 0
+61373487695
Email 8999 0
[email protected]

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
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