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

Summary

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.

Conditions

• Postpartum Hemorrhage (Primary)
• Hemorrhage
• Postpartum Complication
• Delivery ,Complications,Maternal
• Pregnancy Complications
• Cesarean Delivery
• Balloon

Interventions

DEVICE

Rüsch® Balloon Catheter Ch. 24

After cesarean delivery, patients in the intervention group receive the following intervention: The Rüsch® Balloon Catheter Ch. 24 will be inserted directly into the uterus before uterotomy closure. After insertion of the catheter, the catheter balloon is filled up to 80 ml of 0.9% saline solution and connected to the vacuum device whereby an intrauterine vacuum of -60 to a maximum of -70 kPa is applied once the uterotomy is closed. Once the catheter has been positioned, it is left in place for one hour as a prophylactic measure while a vacuum is applied. The device will be removed by draining the liquid in the balloon, after 1 hour of vacuum-induced tamponade. The final decision for removal of the catheter in this study is made by the senior physician responsible for the woman.

OTHER

Ultrasonography

The position of the balloon catheter as well as the condition of the uterine cavity are assessed immediately postoperatively using ultrasonography.

Sponsors & Collaborators

• University of Zurich

  collaborator OTHER

• Christian Haslinger

  lead OTHER

Principal Investigators

• Christian Prof. Dr. med. Christian Haslinger, MD · University Hospital Zürich, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-28

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• Switzerland

Study Locations