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RECRUITING

NCT07019623

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

Sponsor: Christian Haslinger

View on ClinicalTrials.gov

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.

Official title: Uro-catheter Vacuum-induced Uterine Tamponade (U-CaVIT) Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women: a Monocentric Randomized-controlled Pilot Study.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-09

Completion Date

2026-06

Last Updated

2025-06-13

Healthy Volunteers

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 with 60 - 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.

Inclusion Criteria: * Signed informed consent * Maternal age ≥18 years * Gestational age ≥34+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) Exclusion Criteria: * 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) * 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 * Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin * Previous MMC-repair (myelomeningocele-repair) * Clinical diagnosis of chorioamnionitis, sepsis * Allergy to any component of the device * Known and proven diagnosis of bleeding disorder or thrombophilia * Known thrombocytopenia during second half of pregnancy with thrombocytes \< 100 G/L * Known anemia during second half of pregnancy with Hb\<80 g/L The following exclusion criteria will only be checked during the intra-operative assessment before randomization takes place: * Cervix deemed too stiff and/or stenotic for U-CaVIT application, judged by the surgeon during the intra-operative assessment. * Unexpected intraoperative findings incompatible with application of U-CaVIT (see above described clinical situations in exclusion criteria, in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated).

Locations (1)

University Hospital Zurich

Zurich, Switzerland