Affordable Access

Publisher Website

Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial.

Authors
  • Rozenberg, Patrick1
  • Sentilhes, Loïc2
  • Goffinet, François3
  • Vayssiere, Christophe4
  • Senat, Marie-Victoire5
  • Haddad, Bassam6
  • Morel, Olivier7
  • Garabedian, Charles8
  • Vivanti, Alexandre9
  • Perrotin, Franck10
  • Kayem, Gilles11
  • Azria, Elie12
  • Raynal, Pierre13
  • Verspyck, Eric14
  • Sananes, Nicolas15
  • Gallot, Denis16
  • Bretelle, Florence17
  • Seco, Aurélien18
  • Winer, Norbert19
  • Deneux-Tharaux, Catherine20
  • 1 Department of Obstetrics and Gynecology, American Hospital of Paris, Neuilly-sur-Seine, France; Université Paris-Saclay, UVSQ, Inserm, Equipe U1018, Epidémiologie clinique, CESP, Montigny-le-Bretonneux, France. Electronic address: [email protected]. , (France)
  • 2 Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France. , (France)
  • 3 Department of Obstetrics and Gynecology, Hôpital Cochin-Port Royal, AP-HP, Paris, France. , (France)
  • 4 Department of Obstetrics and Gynecology, Hôpital Paule de Viguier, CHU, Toulouse, France. , (France)
  • 5 Department of Obstetrics and Gynecology, Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre, France. , (France)
  • 6 Department of Obstetrics and Gynecology, Hôpital Intercommunal de Créteil, Créteil, France. , (France)
  • 7 Department of Obstetrics and Gynecology, Centre Hospitalier Régional Universitaire de Nancy, Nancy, France. , (France)
  • 8 Department of Obstetrics and Gynecology, Hôpital Jeanne de Flandre, Lille, France. , (France)
  • 9 Department of Obstetrics and Gynecology, Hôpital Antoine-Béclère AP-HP, Clamart, France. , (France)
  • 10 Department of Obstetrics and Gynecology, Hôpital Bretonneau, Tours, France. , (France)
  • 11 Department of Obstetrics and Gynecology, Hôpital Armand Trousseau AP-HP, Paris, France. , (France)
  • 12 Department of Obstetrics and Gynecology, Hôpital Saint Joseph, Paris, France. , (France)
  • 13 Department of Obstetrics and Gynecology, Hôpital André Mignot, Le Chesnay-Rocquencourt, France. , (France)
  • 14 Department of Obstetrics and Gynecology, Centre Hospitalier Universitaire de Rouen, Rouen, France. , (France)
  • 15 Department of Obstetrics and Gynecology, Centre Médico-Chirurgical et Obstétrical, Schiltigheim, France. , (France)
  • 16 Department of Obstetrics and Gynecology, CHU Clermont-Ferrand Site Estaing, Clermont Ferrand, France. , (France)
  • 17 Department of Obstetrics and Gynecology, Hôpital Nord, Marseille, France. , (France)
  • 18 Clinical Research Unit Necker Cochin, APHP, Paris, France. , (France)
  • 19 Department of Obstetrics and Gynecology, Hôpital Mère-Enfant, Nantes, France; NUN INRAE UMR 1280, PhAN Nantes University, Nantes, France. , (France)
  • 20 Obstetrical Perinatal and Paediatric Epidemiology Research Team, Université de Paris Cité, CRESS, INSERM, INRA, Paris, France. , (France)
Type
Published Article
Journal
American journal of obstetrics and gynecology
Publication Date
Nov 01, 2023
Volume
229
Issue
5
Identifiers
DOI: 10.1016/j.ajog.2023.05.014
PMID: 37209893
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79-1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P=.06). The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures. Copyright © 2023 Elsevier Inc. All rights reserved.

Report this publication

Statistics

Seen <100 times