Actively Recruiting
U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.
Led by Christian Haslinger · Updated on 2026-04-22
70
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
C
Christian Haslinger
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Maternal age 18 years or older
- Gestational age 30+0 weeks or more at delivery
- Viable pregnancy
- Planned cesarean delivery
- High risk for postpartum hemorrhage defined by at least one of: previous PPH, obesity (BMI 30 kg/m2 or more), high parity (4 or more previous births at 20 weeks gestation or more), maternal age 45 years or older, multiple pregnancy, polyhydramnios (amniotic fluid index > 25 cm or deepest pocket > 8 cm), suspected fetal macrosomia (estimated fetal weight 4500g or more)
You will not qualify if you...
- Insufficient German or English language skills to understand and sign consent
- Participation in another interventional study
- Emergency cesarean section or cesarean after failed vaginal delivery
- Change from planned vaginal delivery to cesarean during hospitalization
- Regular painful contractions or insufficient time to consider participation
- Uterine or vaginal anomalies (congenital genital tract anomalies)
- Cesarean due to placenta previa or suspected placenta accreta spectrum
- Suspected uterine rupture
- Injuries of cervix or vagina
- Submucous or intramural uterine fibroids bulging into uterine cavity
- Deep endometriosis
- Planned atony prophylaxis with oxytocin due to contraindication for carbetocin
- Previous myelomeningocele repair
- Clinical diagnosis of chorioamnionitis or sepsis
- Known allergy to silicone
- Known bleeding disorder or thrombophilia
- Thrombocytopenia during second half of pregnancy with platelets below 100 G/L
- Anemia during second half of pregnancy with hemoglobin below 80
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
C
Christian Prof. Dr. med. Haslinger, MD
CONTACT
J
Janine Dünner, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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