What is the recommended treatment for a pregnant woman in her mid 30s with antiphospholipid syndrome (APS)?

From the Guidelines

The recommended treatment for a pregnant woman in her mid-30s with antiphospholipid syndrome (APS) is a combination of low-dose aspirin and prophylactic-dose heparin (usually low molecular weight heparin, LMWH), as strongly recommended by the 2020 American College of Rheumatology guideline 1. This approach is based on evidence of moderate strength and aims to prevent complications associated with APS in pregnancy.

• The treatment should include low-dose aspirin (81-100 mg daily) and prophylactic-dose LMWH, such as enoxaparin 40 mg subcutaneously once daily or dalteparin 5,000 units subcutaneously once daily.
• The aspirin can be started preconceptionally when trying to conceive, while LMWH is added once pregnancy is confirmed.
• For women with a history of thrombosis, therapeutic (full-dose) anticoagulation with LMWH may be required, as recommended by the guideline 1.
• The addition of hydroxychloroquine (HCQ) to prophylactic-dose heparin or LMWH and low-dose aspirin therapy may be conditionally recommended for patients with primary APS, as suggested by recent small studies 1.
• Close monitoring by a multidisciplinary team, including maternal-fetal medicine specialists and rheumatologists, is essential, with regular ultrasounds to assess fetal growth and placental function.
• This treatment approach works by addressing the two main pathological mechanisms in APS during pregnancy: thrombosis and inflammation, and has been shown to improve pregnancy outcomes significantly in women with APS 1.

From the FDA Drug Label

Pregnancy Do not administer Heparin Sodium Injection, USP (porcine), preserved with benzyl alcohol, to pregnant women Heparin Sodium Injection, USP (porcine), preservative free, when indicated, should be administered to pregnant women Teratogenic Effects: Pregnancy Category C- Animal reproduction studies have not been conducted with heparin sodium. It is also not known whether heparin sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Heparin sodium should be given to a pregnant woman only if clearly needed.

The recommended treatment for a pregnant woman in her mid 30s with antiphospholipid syndrome (APS) is not directly stated in the provided drug labels. However, based on the information provided, heparin sodium may be considered for use in pregnant women, but only if clearly needed, and the preservative-free formulation should be used.

• Key considerations for the use of heparin in pregnant women with APS include:
  • The potential benefits of heparin therapy in preventing thrombotic events
  • The potential risks of heparin therapy, including bleeding and thrombocytopenia
  • The need for close monitoring of the patient's coagulation parameters and clinical status 2
  • The importance of using the preservative-free formulation of heparin sodium to minimize the risk of adverse effects 2

From the Research

Treatment Options for Antiphospholipid Syndrome (APS) in Pregnancy

The recommended treatment for a pregnant woman in her mid 30s with antiphospholipid syndrome (APS) includes:

• Aspirin and low molecular weight heparin (LMWH) to prevent recurrent pregnancy loss and thrombosis 3, 4, 5, 6
• Hydroxychloroquine (HCQ) has been suggested as an additional treatment to conventional therapy (aspirin and LMWH) due to its anti-inflammatory and anti-thrombotic properties, although more research is needed to confirm its effectiveness 3, 4

Factors Associated with Unfavorable Obstetrical Outcome

The following factors are associated with an increased risk of unfavorable obstetrical outcome in women with APS:

• Presence of lupus erythematosus
• History of thrombosis
• Presence of lupus anticoagulant
• APL triple positivity 3

Current Treatment and Pregnancy Morbidity

Current treatment with heparin and aspirin can improve live birth rates, but other obstetric morbidities remain high, especially in patients with a history of thrombotic events 7 The addition of HCQ to conventional treatment may improve refractory obstetrical APS, but more research is needed to confirm its effectiveness 3, 4

Evidence for Antithrombotic Therapy

A systematic review of randomized controlled trials found that heparin (LMWH or unfractionated heparin) plus aspirin may improve live birth rates in women with recurrent pregnancy loss and antiphospholipid antibodies, but the evidence is of low certainty 6