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

Study acronym: UCaVIT Pilot
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Apr 2026 to Nov 2026
    • Study completion date: Jun 2026 to Nov 2026
    • Start date: May 9, 2025 to May 28, 2025
    • Eligibility criteria shortened, about 48 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07019623
Lead Sponsor Christian Haslinger
Collaborators: University of Zurich
Conditions
(from sponsor)		 Postpartum Hemorrhage (Primary), Hemorrhage, Postpartum Complication, Delivery ,Complications,Maternal, Pregnancy Complications, Cesarean Delivery, Balloon
Related terms Hemorrhage, Postpartum Hemorrhage, Pregnancy Complications
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov