Bakri Shortened In-Utero Time: An RCT (July 2026)

The Bakri Postpartum Balloon was described and first used clinically in 1999 by Dr. Younes N. Bakri (Georgia, USA). It is intended to treat postpartum hemorrhage (PPH). In the United States, it received its first major FDA clearance (via 510(k) for commercial marketing) on April 17, 2002. Manufacturer guidelines for the Bakri (Cook Medical) state that the balloon may be left indwelling for a maximum of 24 hours, but the determination of removal time is left to the clinician once “bleeding is controlled and the patient is stable.” However, the optimal duration of intrauterine balloon tamponade placement remains unclear. One retrospective cohort study from AJOG (Einerson et al) of 274 women found no significant difference in PPH outcomes when intrauterine balloon tamponade was left in place for 2–12 hours, compared with more than 12 hours. However, only 30 women had the intrauterine balloon tamponade placement for 10 hours or less. And remember, this was not a prospective trial looking at a minimum of 2 hours, 2 hours was just the lower margin of the “short duration” group. Now, a new RCT (with authors from Denver and Vermont) published in the July 2026 Green Journal provides new data. In this first of its kind 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. Listen in for details. 1. Durfee, J., Adkins, K., Heyborne, K., Larrea, N., & Schultz, C. (2026). Intrauterine Balloon Tamponade Duration for Postpartum Hemorrhage: A Randomized Controlled Trial. Obstetrics & Gynecology, 148(1), 113–120. https://doi.org/10.1097/AOG.00000000000062952. Garabedian C, Prats C, Seco A, Deneux-Tharaux C, Rozenberg P, Berveiller P. Duration of Intrauterine Balloon Tamponade in Post-Partum Haemorrhage Management After Vaginal Delivery: A Secondary Cohort Analysis From the French TUB Trial. BJOG. 2026 Jan;133(1):123-131. doi: 10.1111/1471-0528.18345. Epub 2025 Sep 1. PMID: 40888007; PMCID: PMC12676195.3. Einerson BD, Son M, Schneider P, Fields I, Miller ES. The association between intrauterine balloon tamponade duration and postpartum hemorrhage outcomes. Am J Obstet Gynecol 2017;216:300.e1–5.