Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612001094864
Acronym
VTE in Pregnancy
Enrollment
38
Registered
2012-10-12
Start date
2007-01-15
Completion date
2010-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Launceston General Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026