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

NCT07019623 | Recruiting

• 1 other identifier: BASEC No. 2024-D0099
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postpartum Hemorrhage; Delivery complications; high risk patients; Pregnancy; Balloon Catheter; Tamponade; prophylactic; Vacuum-induced tamponade

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin

  The primary outcome is to evaluate the postpartum change in hemoglobin (g/L) after cesarean delivery, comparing patients in the intervention group (treated with standard of care (SOC) plus U-CaVIT) to patients in the control group (treated with SOC).

  From baseline (shortly before cesarean delivery) and 48 hours (range 36 to 60 hours) after cesarean delivery

Secondary Outcomes (8)

• Postpartum hemoglobin (g/L)

  Baseline (shortly before cesarean delivery) until hospital discharge (Follow-up 2), estimated 3 - 5 days after delivery

• Blood loss

  24 hours after delivery

• Further PPH treatment/intervention.

  Hospital discharge (Follow-up 2), estimated 3 - 5 days after delivery

• Surgical revision

  24 hours after delivery

• Uterotonic medication, of blood, blood products or coagulation factors.

  24 hours after delivery

Other Outcomes (2)

• Other outcomes: usability of U-CaVIT

  Hospital discharge (Follow-up 2), estimated 3 - 5 days after delivery

• Safety Outcome

  Randomization and hospital discharge (Follow-up 2), estimated 3 - 5 days after delivery

Study Arms (2)

U-CaVIT

EXPERIMENTAL

Prophylactic treatment with Rüsch® Balloon Catheter Ch. 24

Device: Rüsch® Balloon Catheter Ch. 24; Other: Ultrasonography

Control

NO INTERVENTION

Women in the control group will be treated according to the standard of care procedure.

Interventions

Rüsch® Balloon Catheter Ch. 24 DEVICE

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.

U-CaVIT

Ultrasonography OTHER

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

U-CaVIT

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Maternal age ≥18 years
• Gestational age ≥30+0 weeks of pregnancy at day of delivery
• Vital pregnancy
• Delivery mode: planned cesarean delivery
• High-risk patient for PPH specified by the presence of at least one of the following characteristics: Previous PPH, obesity (BMI ≥30 kg/m2), high parity (patient who has had ≥4 previous births (live or stillborn) at ≥20 weeks of gestation), very advanced maternal age ≥45 years, multiple gestation, polyhydramnios (defined as amniotic fluid index \> 25 cm or deepest amniotic fluid pocket \> 8 cm) at admission to delivery, suspected fetal macrosomia (estimated fetal weight ≥ 4500g)

You may not qualify if:

• 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
• Women with regular and painful contractions and women who do not have time for sufficient consideration
• Clinical situations in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated:
• Uterine or vaginal anomalies (genital tract congenital anomalies)
• Cesarean section due to placenta previa or suspected placenta accreta spectrum
• Suspected uterine rupture
• Injuries of the cervix or vagina
• Submucous or intramural uterine fibroids which are buldging into the uterine cavity
• Deep endometriosis \[16, 17\]
• Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin
• Previous MMC-repair (myelomeningocele-repair)
• Clinical diagnosis of chorioamnionitis, sepsis

Sponsors & Collaborators

• Christian Haslinger: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (5)

• Goffman D, Rood KM, Bianco A, Biggio JR, Dietz P, Drake K, Heilman E, Hopkins M, De Four Jones M, Katz T, Martin C, Prasad M, Smid MC, Wine KD, Ryan R, Yong C, Carney PI, Simhan HN. Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device. Obstet Gynecol. 2023 Nov 1;142(5):1006-1016. doi: 10.1097/AOG.0000000000005366. Epub 2023 Sep 13.

  PMID: 37713322 BACKGROUND

• D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.

  PMID: 32909970 BACKGROUND

• Purwosunu Y, Sarkoen W, Arulkumaran S, Segnitz J. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol. 2016 Jul;128(1):33-36. doi: 10.1097/AOG.0000000000001473.

  PMID: 27275795 BACKGROUND

• Haslinger C, Weber K, Zimmermann R. Vacuum-Induced Tamponade for Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2021 Sep 1;138(3):361-365. doi: 10.1097/AOG.0000000000004510.

  PMID: 34352848 BACKGROUND

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage; Pregnancy Complications

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Christian Prof. Dr. med. Christian Haslinger, MD

  University Hospital Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Prof. Dr. med. Haslinger, MD

CONTACT

+41 43 253 75 75; Christian.haslinger@usz.ch

Janine Dünner, MSc

CONTACT

janine.duenner@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analysis of the primary outcome will be performed using blinded treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: This Investigator-initiated Trial (IIT) is a prospective, single-center, randomized-controlled study conducted in a prophylactic setting.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: June 13, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: At the time of publication
• Access Criteria: Access will be provided without limitations. Data will be provided to allow independent computational reproducibility of already published results.

Locations

CH (1)