Insertion of a bladder catheter into the uterus for vacuum therapy to prevent severe bleeding after a cesarean section. A pilot project.
Summary description of the study
The number of bleeding after childbirth is increasing worldwide, including in industrialized countries. One of the main causes is the occurrence of 'uterine atony' after childbirth. 'Uterine atony' is a lack of or reduced contraction (tightening) of the uterine muscle (uterus = womb). A natural contraction of the uterus after childbirth prevents severe bleeding. In this clinical study at the University Hospital Zurich, we want to investigate the benefit and safety of the preventive (prophylactic) insertion of a bladder catheter into the uterus (to create a vacuum) after a cesarean section. This should prevent severe postpartum bleeding. We plan to include 70 patients who have undergone a cesarean section.
(BASEC)
Intervention under investigation
The catheter is inserted into the uterus to create a vacuum. Through the vacuum, the uterus contracts (similar to natural contraction), which should stop the postpartum bleeding. This is a therapeutic approach that has already been applied since 2023 at the University Hospital Zurich for severe bleeding. In this study, we want to investigate whether we can already, at an earlier step, prevent the occurrence of increased bleeding – that is, whether the prophylactic insertion of this catheter can prevent the occurrence of bleeding itself.
(BASEC)
Disease under investigation
Severe bleeding after cesarean section
(BASEC)
Signed informed consent Age >= 18 years Gestational age >= 34 weeks (age of the unborn child) Planned cesarean section Risk factor for increased bleeding after cesarean section (BASEC)
Exclusion criteria
Insufficient language skills in German or English to understand and sign the informed consent. Emergency cesarean section Participation in another interventional study Women with regular and painful contractions and women who do not have time for adequate consideration regarding study participation (min. 1 hour). Clinical situations where vacuum-induced treatment of the uterus is likely to be ineffective or contraindicated. (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Prof. Dr. med. Christian Haslinger Klinik für Geburtshilfe, UniversitätsSpital Zürich
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Christian Haslinger
+41 43 253 75 75
Christian.haslinger@clutterusz.chKlinik für Geburtshilfe, UniversitätsSpital Zürich
(BASEC)
General Information
University Hospital Zrich, Switzerland
+41 43 253 75 75+41 44 255 46 13
Christian.haslinger@clutterusz.chChristian.haslinger@clutterusz.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
21.01.2025
(BASEC)
ICTRP Trial ID
NCT07019623 (ICTRP)
Official title (approved by ethics committee)
Einlage eines Blasenkatheters in die Gebärmutter zur Vakuumtherapie, um starke Blutungen nach einem Kaiserschnitt zu verhindern. Ein Pilotprojekt. (BASEC)
Academic 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. (ICTRP)
Public title
U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. (ICTRP)
Disease under investigation
Postpartum Hemorrhage (Primary)HemorrhagePostpartum ComplicationDelivery ,Complications,MaternalPregnancy ComplicationsCesarean DeliveryBalloon (ICTRP)
Intervention under investigation
Device: Rsch Balloon Catheter Ch. 24Other: Ultrasonography (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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). (ICTRP)
not available
Primary and secondary end points
Change in hemoglobin (ICTRP)
Postpartum hemoglobin (g/L);Blood loss;Further PPH treatment/intervention.;Surgical revision;Uterotonic medication, of blood, blood products or coagulation factors.;Postoperative coagulum;Secondary PPH;Bishop score (cervix score) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University of Zurich (ICTRP)
Additional contacts
Christian Prof. Dr. med. Christian Haslinger, MDChristian Prof. Dr. med. Haslinger, MDChristian Prof. Dr. Haslinger, MD, Christian.haslinger@usz.chchristian.haslinger@usz.ch, +41 43 253 75 75+41 44 255 46 13, University Hospital Zrich, Switzerland (ICTRP)
Secondary trial IDs
BASEC No. 2024-D0099 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT07019623 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available