Obstet Gynecol Sci.  2017 Nov;60(6):535-541. 10.5468/ogs.2017.60.6.535.

Efficacy and safety of venous thromboembolism prophylaxis with fondaparinux in women at risk after cesarean section

• Kawaguchi
• Haruta S
• Kobayashi

• KMID: 2418354
• DOI: http://doi.org/10.5468/ogs.2017.60.6.535

Abstract

OBJECTIVES
Cesarean section is associated with an increased risk for venous thromboembolism (VTE). The safety and efficacy of primary prophylaxis of fondaparinux, a synthetic sulfated pentasaccharide heparin analog, in women at risk after cesarean section is uncertain.
METHODS
This was a retrospective study of 295 cases of pregnant women presenting to a tertiary referral center of Nara, Japan, to evaluate the usefulness of thromboprophylaxis with fondaparinux after cesarean delivery between 2011 and 2012. Patients were initially received unfractionated heparin (once 5,000 IU subcutaneously, twice a day), starting 6 hours after cesarean section for 24 hours, and then treated with fondaparinux (once 2.5 mg daily, subcutaneously) for 5 days. The primary efficacy end-point was an improvement in the incidence of symptomatic VTE or fatal post-cesarean pulmonary thromboembolism. The primary safety end-point was major bleeding during treatment.
RESULTS
There were neither any episodes of symptomatic VTE cases nor maternal deaths. A total of 10 patients had a bleeding event. Major bleeding complication was observed in 2 (0.68%) of 295 patients receiving fondaparinux. Non-major bleeding into critical sites was observed in 8 patients, often at surgical sites, and recovery was not delayed.
CONCLUSION
This study demonstrates the safety and efficacy of fondaparinux in women at high risk of VTE after cesarean section. Large phase trials comparing clinical outcomes with fondaparinux across a wide spectrum of patients are needed to confirm these observations.

Keyword

Cesarean section; Fondaparinux; Prevention & control; Venous thromboembolism

MeSH Terms

Cesarean Section*
Female
Hemorrhage
Heparin
Humans
Incidence
Japan
Maternal Death
Pregnancy
Pregnant Women
Pulmonary Embolism
Retrospective Studies
Tertiary Care Centers
Venous Thromboembolism*
Heparin

Figure

• 

  Fig. 1 Study protocol. C/S, cesarean section; IPC, intermittent pneumatic compression; UFH, unfractionated heparin.

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