Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07019623

Uro-catheter Vacuum-induced Uterine Tamponade Versus Standard 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

N/A

Total Duration

On this page

Sponsors

C

Christian Haslinger

Lead Sponsor

U

University of Zurich

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade) using the Rüsch® Brillant Silicone Balloon Catheter to prevent atonic postpartum hemorrhage (PPH) in high-risk women undergoing cesarean delivery. PPH is a leading cause of maternal mortality and morbidity worldwide, often caused by uterine atony, which accounts for 60-80% of cases. This study aims to assess the performance, safety, and feasibility of this vacuum-induced tamponade method compared to standard care, especially given the need for cost-effective and minimally invasive prevention strategies for PPH. Participants are randomly assigned to receive either the U-CaVIT intervention or standard care. In the intervention group, after cesarean delivery and before closing the uterotomy, the Rüsch® Balloon Catheter is inserted into the uterus, inflated with up to 80 mL of saline, and connected to a vacuum device applying a low-level intrauterine vacuum for one hour as a preventive measure. The catheter is then removed by draining the balloon fluid. The control group receives the usual standard care procedure. Ultrasonography is used postoperatively to check the catheter's position and the uterine cavity condition. During the study, participants are monitored through blood tests measuring hemoglobin levels before delivery and at specified times after delivery, blood loss measurements within 24 hours, and evaluation of any further PPH treatments or surgical interventions. Secondary assessments include uterotonic medication use, postoperative coagulum, and cervix scoring. The total follow-up extends until hospital discharge, approximately 3 to 5 days after delivery. The study will evaluate changes in hemoglobin as the primary outcome to understand the effectiveness of the U-CaVIT method in preventing PPH.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Female aged 18 years or older
  • Gestational age of 30 weeks or more at delivery
  • Vital pregnancy
  • Planned cesarean delivery
  • High risk for postpartum hemorrhage with at least one of: previous PPH, obesity (BMI ≥30), four or more previous births at 20 weeks or more, maternal age 45 or older, multiple gestation, polyhydramnios, or suspected fetal macrosomia (estimated weight ≥4500g)
Not Eligible

You will not qualify if you...

  • Insufficient German or English language skills
  • Participation in another interventional study
  • Emergency cesarean section or cesarean after failed vaginal delivery
  • Change from planned vaginal to cesarean delivery during hospitalization
  • Regular and painful contractions preventing sufficient consideration
  • Uterine or vaginal anomalies (congenital anomalies)
  • Cesarean due to placenta previa or suspected placenta accreta spectrum
  • Suspected uterine rupture
  • Cervix or vaginal injuries
  • 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 silicone allergy
  • Diagnosed bleeding disorders or thrombophilia
  • Thrombocytopenia with platelets below 100 G/L in second half of pregnancy
  • Anemia with hemoglobin below 80 in second half of pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 1 hour during cesarean delivery

Participants undergo cesarean delivery. Those in the intervention group receive the Rüsch® Balloon Catheter inserted into the uterus before uterotomy closure, with the balloon filled and connected to a vacuum device applying negative pressure for one hour as a prophylactic measure to prevent postpartum hemorrhage. The catheter is then removed by draining the balloon fluid. Ultrasonography is performed immediately postoperatively to assess the catheter position and uterine condition.

1 visit (in-person, during cesarean delivery and immediate postoperative period)

Follow-up

Duration - 3 to 5 days after delivery

Participants are monitored for outcomes including hemoglobin levels, blood loss, need for additional postpartum hemorrhage treatments, surgical revisions, coagulum presence, and secondary postpartum hemorrhage until hospital discharge, typically 3 to 5 days after delivery.

Approximately 1 to 2 visits during hospital stay

Trial Site Locations

Total: 1 location

1

University Hospital Zurich

Zurich, Switzerland, 8091

Actively Recruiting

Loading map...

Research Team

C

Christian Prof. Dr. med. Haslinger, MD

J

Janine Dünner, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Prospective Cohort Study on the Dynamic Monitoring of Seru...

Polycystic Ovary Syndrome

Actively Recruiting

1 location

Labor Induction in Low-risk Women at 39 Weeks of Gestation: ...

Cesarean Delivery

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial