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#Grand Rounds

Cochrane Review: TXA for Postpartum Hemorrhage – Safe and Effective?

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BACKGROUND AND PURPOSE:

  • This current Cochrane review (Shakur et al., Cochrane Database of Systematic Reviews, 2018) focused specifically at antifibrinolytic drugs for the treatment of primary PPH

METHODS:

  • Systematic review and meta-analysis
  • Search methods
    • Searches included: Cochrane Pregnancy and Childbirth’s Trials Register | ClinicalTrials.gov | WHO International Clinical Trials Registry Platform (ICTRP) | Reference lists of retrieved studies
  • Inclusion criteria
    • RCTs
    • Studies that included antifibrinolytic drugs
      • Aprotinin | TXA | epsilon-aminocaproic acid (EACA) | Aminomethylbenzoic acid
    • Any route of administration
    • Indication: Primary PPH
  • Exclusion criteria
    • Quasi-randomized trials or cross-over studies
    • Abstracts with insufficient information to assess biases
  • Participants
    • Women after birth following a pregnancy of at least 24 weeks’ gestation with a diagnosis of PPH
    • Mode of birth (vaginal or cesarean), and other aspects of third stage management were not examined
  • Primary outcomes
    • Mortality due to bleeding
    • All-cause mortality*
    • Serious maternal morbidity
  • Secondary outcomes included mortality from other causes, shock, amount of blood loss, transfusion etc.
  • Data collection and analysis
    • Two review authors independently extracted data from each study using an agreed form and checked for accuracy
    • Quality of evidence was rated as ‘high’, ‘moderate’, ‘low’ or ‘very low’ according to the GRADE criteria

RESULTS:

  • 3 trials |20,412 women
    • No trials assessed EACA, aprotinin or aminomethylbenzoic acid
    • For the remaining 3 studies, standard care plus IV TXA for the treatment of primary PPH was compared to placebo or standard of care alone
  • The WOMAN trial contributed over 99% of the data and was assessed as low risk of bias (for more on this study, see ‘Related ObG Topics’ below)
    • The quality of evidence varied for different outcomes
  • Overall, evidence was moderate to high quality
  • IV TXA reduces the risk of maternal death due to bleeding
    • Risk ratio (RR) 0.81 (95% CI, 0.65 to 1.00; two trials, 20,172 women; quality of evidence: moderate)
    • Result not impacted by mode of birth
  • Timing of TXA treatment was critical for effect size
    • <1 hr: RR 0.80 (95% CI,0.55 to 1.16)
    • 1 to 3 hrs: RR 0.60 (95% CI, 0.41 to 0.88)
    • >3 hrs: RR 1.07 (95% CI, 0.76 to 1.51)
  • There was no heterogeneity in the effect by mode of birth
  • Fewer all cause deaths but not statistically significant
  • TXA did not reduce the risk of
    • Serious maternal morbidity: RR 0.99 (95% CI, 0.83 to 1.19; one trial, 20,015 women; quality of evidence: high)
    • Hysterectomy to control bleeding: RR 0.95 (95% CI, 0.81 to 1.12; one trial, 20,017 women; quality of evidence: high)
    • Blood transfusion: RR 1.00 (95% CIm 0.97 to 1.03; two trials, 20,167 women; quality of evidence: moderate)
    • Maternal vascular occlusive events: RR 0.88 (95% CI, 0.54 to 1.43; one trial, 20,018 women; quality of evidence: moderate)
  • There was an increase in the use of brace sutures (B-Lynch)  in the TXA group
    • RR 1.19 (95% CI, 1.01 to 1.41)
  • There was a reduction in the need for laparotomy in the TXA group
    • RR 0.64 (95% CI 0.49 to 0.85)

CONCLUSION:

  • When IV TXA was used to treat PPH
    • There as reduced mortality risk related to bleeding, regardless of mode of birth
    • No increase in risk for thromboembolic events
  • Findings in obstetrics are consistent with that of trauma settings
  • Authors recommend exploring other routes of administration for out-of-hospital settings where IV may not be readily accessible

Learn More – Primary Sources:

Antifibrinolytic drugs for treating primary postpartum haemorrhage

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Related ObG Topics:

How Effective is Intrauterine Balloon Tamponade for Severe Postpartum Hemorrhage
Postpartum Hemorrhage Prophylaxis: The World Health Organization Recommendations
Postpartum Hemorrhage – Medications to Treat Uterine Atony 
Results From the Landmark Trial on Tranexamic Acid for Postpartum Hemorrhage
Does Prophylactic TXA Reduce Postpartum Hemorrhage?

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