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Antithrombin did not significantly prolong pregnancy in early-onset severe preeclampsia. The recombinant human antithrombin-gamma group showed increased rates of hemorrhage and anemia compared to placebo.

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Area of Science:

  • Obstetrics and Gynecology
  • Maternal-Fetal Medicine
  • Hematology

Background:

  • Preeclampsia poses risks to fetal well-being, making pregnancy prolongation a key management goal.
  • Early-onset severe preeclampsia requires careful management to balance maternal and fetal outcomes.

Purpose of the Study:

  • To assess the efficacy and safety of antithrombin in extending pregnancy duration for women with early-onset severe preeclampsia.
  • To compare pregnancy prolongation and adverse events between antithrombin and placebo groups.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial was conducted across 61 institutions.
  • Participants with early-onset severe preeclampsia (24-31 weeks gestation) and ≤100% antithrombin activity were randomized to receive recombinant human antithrombin-gamma (rhAT-gamma) or placebo.
  • The primary endpoint was the number of days from treatment initiation to delivery.

Main Results:

  • No significant difference in pregnancy prolongation was observed between the rhAT-gamma group (16.9 days) and the placebo group (13 days) (P=0.07).
  • The rhAT-gamma group experienced a higher incidence of hemorrhage-related adverse events (19.0% increase) and anemia (16.8% increase) compared to the placebo group.

Conclusions:

  • Recombinant human antithrombin-gamma did not significantly prolong pregnancy in women with early-onset severe preeclampsia.
  • Treatment with rhAT-gamma was associated with increased risks of hemorrhage and anemia.