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Grand Rounds

WOMAN Trial Secondary Analysis: Do Invasive Treatments for PPH Increase Sepsis Risk?

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BACKGROUND AND PURPOSE:

  • Cornelissen et al. (International Journal of Gynecology & Obstetrics, 2019) used the World Maternal Antifibrinolytic (WOMAN) trial dataset to determine whether there is an association between invasive treatment for postpartum hemorrhage (PPH) and sepsis

METHODS:

  • Secondary data analysis of the WOMAN RCT (see ‘Related ObG Topics’ below)
    • 20,060 women | 193 facilities | 21 countries
  • Participants in WOMAN trial
    • >16 years with PPH
  • PPH definition: EBL >500 mL after vaginal delivery | >1000 mL after cesarean | Any blood loss sufficient to compromise hemodynamic stability
  • Definitions
    • Sepsis:
    • Severe sepsis: sepsis plus organ dysfunction
  • Primary outcome
    • Sepsis defined as infection plus systemic inflammatory response (original definition in the WOMAN trial)
  • Secondary outcome
    • Severe Sepsis: Defined as sepsis with organ dysfunction
  • Main exposures
    • Manual removal of placenta | Hysterectomy | Brace sutures | Artery ligation | Intrauterine tamponade | “laparotomy for other reasons”
  • Data analysis
    • Risk factors for sepsis examined using logistic regression with random effects
    • Odds ratio (OR), 95% confidence intervals (CI), and P values (<0.05 considered significant) were calculated
    • Adjustments made for the following a prior risk confounders
      • Age, | Type of delivery | Signs of hemodynamic instability | Place of delivery | Prophylactic use of uterotonics | Primary cause of hemorrhage

RESULTS:

  • Cumulative incidence
    • Sepsis: 1.8%
    • Severe sepsis: 0.5%
  • All-cause mortality was higher in women with severe sepsis
    • Sepsis: 2.2%
    • Severe sepsis: 40.4%
  • Invasive treatments for PPH increased the risk of both sepsis and severe sepsis
    • Sepsis
      • Intrauterine tamponade: adjusted OR 1.77 (95% CI, 1.21 to 2.59; P=0.004)
      • Hysterectomy: aOR 1.97 (95% CI, 1.49 to 2.65; P<0.001)
      • Laparotomy: aOR 6.63 (95% CI, 4.29 to 10.24; P<0.001)
    • Severe sepsis
      • Intrauterine tamponade: aOR 2.60 (95% CI, 1.47 to 4.59: P=0.002)
      • Hysterectomy: aOR 1.97 (95% CI, 0.83 to 2.46; P=0.033)
      • Laparotomy: aOR 5.35 (95% CI, 2.61 to 10.98; P<0.001)
  • Prophylactic antibiotic use was not recorded and therefore could not be assessed

CONCLUSION:

  • Invasive PPH treatments were significantly associated with increased risk of sepsis  
  • The authors state that

Primary research is urgently required to investigate this finding further and examine ways to reduce the risk, including clearer guidelines on the use of prophylactic antibiotics.

Learn More – Primary Sources:

Secondary analysis of the WOMAN trial to explore the risk of sepsis after invasive treatments for postpartum hemorrhage

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Related ObG Topics:

Results From the Landmark Trial on Tranexamic Acid for Postpartum Hemorrhage
Antibiotics for Reducing Risk of Endometritis Following Intrauterine Balloon Tamponade
SMFM & CMQCC Guidelines: Making the Diagnosis of Sepsis in Pregnancy
SMFM & CMQCC Guidelines: Management of Sepsis in Pregnancy
ACOG Guidance: Antibiotic Prophylaxis during Labor and Delivery

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