Intrauterine Balloon Tamponade Duration for Postpartum Hemorrhage

OBJECTIVE: To determine whether an intrauterine balloon tamponade duration of 6 hours is noninferior to a duration of 18 hours for controlling bleeding after vaginal delivery, as measured by quantitative blood loss. METHODS: In this pragmatic randomized trial of noninferiority, a 6-hour duration of intrauterine balloon tamponade usage for postpartum hemorrhage (PPH) control was compared with an 18-hour duration. We randomized participants with PPH due to uterine atony after vaginal delivery to an intrauterine balloon tamponade duration of 6 hours or 18 hours in a 1:1 ratio using stratified block randomization based on quantitative blood loss at the time of intrauterine balloon tamponade placement. The primary outcome was the total quantitative blood loss from the placement of the intrauterine balloon tamponade to 18 hours postplacement. Sixty-four participants were estimated to be required to determine whether total quantitative blood loss between groups was above our chosen noninferiority margin of 250 mL. Noninferiority t tests were considered noninferior at P