485 Efficacy of early versus late intrauterine balloon tamponade in the management of severe postpartum hemorrhage

Abstract

Intrauterine balloon tamponade (IUBT) is used to achieve hemostasis in refractory postpartum hemorrhage (PPH) unresponsive to uterotonic therapy. Its optimal timing is unknown: as final first-line therapy, with prostaglandin administration, or as initial second-line therapy after prostaglandin treatment has failed. This open multicenter randomized trial included women aged ≥18 years, with a vaginal delivery ≥35 weeks and PPH unresponsive to oxytocin. Exclusion criteria were PPH due to cervicovaginal lacerations without uterine hemorrhage, uterine rupture, or placenta accreta. Women were randomized into: A study group: IV infusion of sulprostone (prostaglandin) started simultaneously with IUBT (ebb®, Clinical Innovation). If bleeding persisted 30 minutes afterwards, an invasive emergency procedure was performed. A control group: IV sulprostone infusion only. If bleeding persisted ≥30 minutes, IUBT was performed. If bleeding persisted 30 minutes after IUBT, an invasive emergency procedure took place. The primary binary composite outcome was calculated peripartum blood loss >1000 mL and/or transfusion of at least 3 RBC units (ClinicalTrials.gov NCT02226731). Between February 2017 and December 2019, 403 women were included. After exclusion of 11 (6 secondarily ineligible, 5 withdrew consent), the intention-to-treat analysis included 392 women, and the per protocol group 331. The groups were similar for women's baseline characteristics, except the rate of women with an estimated blood loss > 1000 mL when sulprostone administration began was higher in the study group (Table 1). After adjustment for this characteristic, the primary outcome was significantly lower in the study group: 67.2% vs 74.3%, aRR (95% CI), 0.87 (0.77-0.99); number needed to treat (95%CI):13.95 (6.22-52.25). Secondary outcomes did not differ between the groups. Per protocol results were similar (Table 2). Early IUBT used as final first-line therapy, together with prostaglandin administration, reduced the risk of severe PPH, compared with later placement.View Large Image Figure ViewerDownload Hi-res image Download (PPT)