U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.

This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery. The U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.

NCT Number	NCT07019623
Lead Sponsor	Christian Haslinger Collaborators: University of Zurich
Conditions	Postpartum Hemorrhage (Primary), Hemorrhage, Postpartum Complication, Delivery ,Complications,Maternal, Pregnancy Complications, Cesarean Delivery, Balloon
Enrollment	70 participants
Start Date	2025-05-28
Primary Completion	2026-11 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-04-22