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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChristian Haslinger

About this trial

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.

Eligibility criteria

Qualifiers

Signed informed consent

Maternal age ≥18 years

Gestational age ≥30+0 weeks of pregnancy at day of delivery

Vital pregnancy

Disqualifiers

Insufficient language skills in German or English to understand and sign informed consent

Participation in another interventional study

Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)

Subjects who change their delivery plan from vaginal to cesarean section in the course of hospitalization

Trial design

Treatments tested in this trial

  • Rüsch® Balloon Catheter Ch. 24
  • Ultrasonography

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Christian Haslinger

Lead sponsor

University of Zurich

Sponsor institution

University of Zurich

Collaborator