RESUMEN
OBJECTIVE: When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. STUDY DESIGN: These data are from a postmarketing surveillance study of a novel dual-balloon catheter tamponade device, the Belfort-Dildy Obstetrical Tamponade System (ebb). RESULTS: A total of 57 women were enrolled: 55 women had the diagnosis of postpartum hemorrhage, and 51 women had uterine balloon placement within the uterine cavity. This study reports the outcomes in the 51 women who had uterine balloon placement within the uterine cavity for treatment of postpartum hemorrhage, as defined by the "Instructions for Use." We further assessed 4 subgroups: uterine atony only (n = 28 women), placentation abnormalities (n = 8 women), both uterine atony and placentation abnormalities (n = 9 women), and neither uterine atony nor placentation abnormalities (n = 6 women). The median (range) time interval between delivery and balloon placement was 2.2 hours (0.3-210 hours) for the entire cohort (n = 51 women) and 1.3 hours (0.5-7.0 hours) for the uterine atony only group (n = 28 women). Bleeding decreased in 22/51 of cases (43%), stopped in 28/51 of cases (55%), thus decreased or stopped in 50/51 of the cases (98%) after balloon placement. Nearly one-half (23/51) of all women required uterine balloon volumes of >500 mL to control bleeding. CONCLUSION: We conclude that uterine/vaginal balloon tamponade is very useful in the management of postpartum hemorrhage because of uterine atony and abnormal placentation.