Laura Cornelissen1,2, Susannah Woodd3, Haleema Shakur-Still4, Bukola Fawole5, Shehla Noor6, Saturday Etuk7, Adesina Lawrence Akintan8, Rizwana Chaudhri9, Ian Roberts4. 1. London School of Hygiene and Tropical Medicine, London, UK. 2. Department of Obstetrics and Gynecology, UZ Leuven, Leuven, Belgium. 3. Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK. 4. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, UK. 5. Department of Obstetrics and Gynecology, National Institute of Maternal and Child Health, College of Medicine, University of Ibadan, Ibadan, Nigeria. 6. Department of Obstetrics and Gynecology, Ayub Medical and Teaching Institute, Abbottabad, Pakistan. 7. Department of Obstetrics and Gynecology, College of Medical Sciences, University of Calabar, Calabar, Nigeria. 8. Department of Obstetrics and Gynecology, Mother and Child Hospital, Akure, Nigeria. 9. Department Obstetrics and Gynecology, Rawalpindi Medical University, Rawalpindi, Pakistan.
Abstract
OBJECTIVE: To examine the association between the use of invasive treatments for postpartum hemorrhage and the risk of sepsis and severe sepsis. METHODS: Secondary data analysis of the WOMAN randomized controlled trial, including 20 060 women with postpartum hemorrhage in 21 countries. Logistic regression with random effects was used. RESULTS: The cumulative incidence was 1.8% for sepsis and 0.5% for severe sepsis. All-cause mortality was 40.4% in women with severe sepsis versus 2.2% for women without. After adjusting for bleeding severity and other confounders, intrauterine tamponade, hysterectomy, and laparotomy increased the risk of sepsis (aOR 1.77 [95% CI 1.21-2.59], P=0.004; aOR 1.97 [95% CI 1.49-2.65], P<0.001; and aOR 6.63 [95% CI 4.29-10.24], P<0.001, respectively) and severe sepsis (aOR 2.60 [95% CI 1.47-4.59], P=0.002; aOR 1.97 [95% CI 0.83-2.46], P=0.033; and aOR 5.35 [95% CI 2.61-10.98], P<0.001, respectively). CONCLUSION: In this secondary data analysis, certain invasive treatments for postpartum hemorrhage appear to increase the risk of sepsis. Further research is needed to confirm this finding and investigate the role of prophylactic antibiotics during these procedures. The harms and benefits of such interventions must be carefully weighed, both in treatment guidelines and during individual patient management. TRIAL REGISTRATION: ISRCTN76912190.
RCT Entities:
OBJECTIVE: To examine the association between the use of invasive treatments for postpartum hemorrhage and the risk of sepsis and severe sepsis. METHODS: Secondary data analysis of the WOMAN randomized controlled trial, including 20 060 women with postpartum hemorrhage in 21 countries. Logistic regression with random effects was used. RESULTS: The cumulative incidence was 1.8% for sepsis and 0.5% for severe sepsis. All-cause mortality was 40.4% in women with severe sepsis versus 2.2% for women without. After adjusting for bleeding severity and other confounders, intrauterine tamponade, hysterectomy, and laparotomy increased the risk of sepsis (aOR 1.77 [95% CI 1.21-2.59], P=0.004; aOR 1.97 [95% CI 1.49-2.65], P<0.001; and aOR 6.63 [95% CI 4.29-10.24], P<0.001, respectively) and severe sepsis (aOR 2.60 [95% CI 1.47-4.59], P=0.002; aOR 1.97 [95% CI 0.83-2.46], P=0.033; and aOR 5.35 [95% CI 2.61-10.98], P<0.001, respectively). CONCLUSION: In this secondary data analysis, certain invasive treatments for postpartum hemorrhage appear to increase the risk of sepsis. Further research is needed to confirm this finding and investigate the role of prophylactic antibiotics during these procedures. The harms and benefits of such interventions must be carefully weighed, both in treatment guidelines and during individual patient management. TRIAL REGISTRATION: ISRCTN76912190.
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