BACKGROUND AND PURPOSE:

• TXA, based on evidence, is an effective treatment for PPH (see related ‘Related ObG Topics’ below)
• Sentilhes et al. (NEJM, 2018) examined whether addition of prophylactic administration of tranexamic acid (TXA) vs oxytocin reduces incidence of postpartum hemorrhage

METHODS:

• Multicenter, double-blind, randomized, controlled trial (RCT)
• Participants
  • ≥18 years, singleton pregnancy
  • ≥35w0d
  • Planning vaginal delivery
• Women were randomized to one of the following
  • 1g TXA IV
  • Matched placebo
• Procedure
  • IV slowly administered over 30 – 60 seconds during the 2 minutes after delivery after routine prophylactic oxytocin IV at delivery of the anterior shoulder and clamping of the umbilical cord
• Statistical analysis
  • Power calculation: 3628 women with a vaginal delivery would provide a power of at least 90%
• Primary outcome
  • PPH (≥ 500 ml)
  • Objective collection device
• Secondary outcomes
  • Multiple additional PPH outcomes (e.g., blood loss >500 ml and at least 1000 ml, total EBL, proportion of women requiring supplementary uterotonics etc.)

RESULTS:

• 3,891 women had a vaginal delivery on the study
  • 1945 TXA group | 1946 placebo group

Primary Outcome – PPH

• There was no difference between the TXA group (8.1%) vs placebo group (9.8%)
  • Relative risk (RR) 0.83; 95% CI, 0.68 to 1.01 (P=0.07)

Secondary Outcomes

• Women in the TXA group (7.8%) had a lower rate of provider-assessed clinically significant postpartum hemorrhage vs placebo group (10.4%)
  • RR 0.74; 95% CI, 0.61 to 0.91 (adjusted P=0.04)
• Women in TXA group (7.2%) received additional uterotonic agents less often compared to placebo group (9.7%)
  • RR 0.75; 95% CI, 0.61 to 0.92 (adjusted P=0.04)
• The incidence of thromboembolic events in the 3 months after delivery did not differ between groups
• Other Secondary outcomes: No differences between groups

CONCLUSION:

• The addition of tranexamic acid did not significantly reduce rates of PPH (≥ 500 ml) for women who delivered vaginally and had received prophylactic oxytocin
• Further trials are required to assess the role for prophylactic TXA for cesarean delivery

Learn More – Primary Sources:

Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery

Related ObG Topics:

Results From the Landmark Trial on Tranexamic Acid for Postpartum Hemorrhage

Postpartum Hemorrhage – Medications to Treat Uterine Atony 

How does TXA Measure Up as a Treatment for Menorrhagia?