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)
Scientific Information
not available
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
not available
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
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available