From the Guidelines
Anticoagulation therapy improves pregnancy outcomes in patients with thrombophilia, specifically those with antiphospholipid antibody syndrome or a history of pregnancy losses, by reducing the risk of placental thrombosis and subsequent pregnancy complications. According to the American College of Chest Physicians evidence-based clinical practice guidelines 1, for women who fulfill the laboratory criteria for antiphospholipid antibody (APLA) syndrome and meet the clinical APLA criteria based on a history of three or more pregnancy losses, antepartum administration of prophylactic or intermediate-dose unfractionated heparin or prophylactic low-molecular-weight heparin combined with low-dose aspirin (75-100 mg/d) is recommended over no treatment. Some key points to consider when implementing anticoagulation therapy in these patients include:
- The use of low-molecular-weight heparin (LMWH) for the prevention and treatment of VTE in pregnant women, instead of unfractionated heparin 1
- The continuation of anticoagulants for at least 6 weeks postpartum (for a minimum duration of therapy of 3 months) in women with acute VTE 1
- The importance of regular monitoring of platelet counts during the first two weeks of therapy to detect heparin-induced thrombocytopenia
- Patient education on injection technique, signs of bleeding, and when to seek medical attention However, for women with inherited thrombophilia and a history of pregnancy complications, antithrombotic prophylaxis is not recommended unless they have additional risk factors 1. In terms of specific treatment regimens, a combination of LMWH and low-dose aspirin may be beneficial for women with recurrent pregnancy loss and thrombophilia. Overall, the decision to initiate anticoagulation therapy in patients with thrombophilia should be individualized, taking into account the patient's specific risk factors and medical history.
From the FDA Drug Label
There are no adequate and well-controlled studies in pregnant women. A retrospective study reviewed the records of 604 women who used Enoxaparin Sodium Injection during pregnancy. A total of 624 pregnancies resulted in 693 live births. There were 72 hemorrhagic events (11 serious) in 63 women. There were 14 cases of neonatal hemorrhage. Major congenital anomalies in live births occurred at rates (2. 5%) similar to background rates.
Pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilias, have an increased risk of other maternal complications and fetal loss regardless of the type of anticoagulant used.
The FDA drug label does not answer the question.
From the Research
Anticoagulation Therapy in Patients with Thrombophilia
- The use of anticoagulant agents during pregnancy in patients with thrombophilia has been studied in various research papers 2, 3, 4, 5, 6.
- According to the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy, anticoagulation therapy is recommended for women with a history of venous thromboembolism (VTE) or thrombophilia 2.
- A study published in the Cochrane database of systematic reviews found that anticoagulant agents, such as aspirin and heparin, did not improve live-birth rates in women with recurrent miscarriage without antiphospholipid syndrome 3.
- Another study published in the Journal of thrombosis and haemostasis found that low-molecular weight heparin (LMWH) may have a positive effect on pregnancy outcome after single or recurrent abortions, but more research is needed 4.
- A review published in Advances in clinical and experimental medicine found that direct oral anticoagulants (DOACs) may be an attractive therapeutic option for patients with thrombophilia, but more research is needed to confirm their efficacy and safety 5.
- A retrospective cohort study published in The journal of maternal-fetal & neonatal medicine found that women with double thrombophilias did not have a greater risk for obstetric complications compared to women with single thrombophilias when treated with anticoagulation 6.
Pregnancy Outcomes
- The studies suggest that anticoagulation therapy may improve pregnancy outcomes in patients with thrombophilia, but the evidence is not conclusive 2, 4, 6.
- The use of anticoagulant agents, such as LMWH, may reduce the risk of recurrent miscarriage and improve live-birth rates in women with thrombophilia 4.
- However, the studies also suggest that the risk of obstetric complications is not significantly different between women with single and double thrombophilias when treated with anticoagulation 6.
Treatment Options
- The treatment options for patients with thrombophilia include anticoagulant agents, such as LMWH, unfractionated heparin, and DOACs 2, 3, 4, 5.
- The choice of treatment depends on the individual patient's risk factors and medical history 2, 5.
- More research is needed to confirm the efficacy and safety of different treatment options for patients with thrombophilia 3, 4, 5.