BridgeMD
Compares treatment options for Postpartum Hemorrhage (Primary)
Official title U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.
ClinicalTrials.gov ID: NCT07019623
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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
You likely can't join if
- Insufficient language skills in German or English to understand and sign informed consent
- Participation in another treatment study
- Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)
- people 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:
See the full eligibility criteria
- 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...
- Insufficient language skills in German or English to understand and sign informed consent
- Participation in another treatment study
- Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)
- people 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
- Known allergy to silicone
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.