Insertion of a bladder catheter into the uterus for vacuum therapy to prevent severe bleeding after a cesarean section. A pilot project.

Switzerland (ICTRP)

ID di studio ICTRP
NCT07019623 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Einlage eines Blasenkatheters in die Gebärmutter zur Vakuumtherapie, um starke Blutungen nach einem Kaiserschnitt zu verhindern. Ein Pilotprojekt. (BASEC)

Titolo accademico
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)

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

Malattie studiate
Postpartum Hemorrhage (Primary)HemorrhagePostpartum ComplicationDelivery ,Complications,MaternalPregnancy ComplicationsCesarean DeliveryBalloon (ICTRP)

Intervento studiato
Device: Rsch Balloon Catheter Ch. 24Other: Ultrasonography (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
University of Zurich (ICTRP)

Contatti aggiuntivi
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)

ID secondari
BASEC No. 2024-D0099 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07019623 (ICTRP)