The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section
1 other identifier
observational
780
1 country
1
Brief Summary
This study aims to find out if there are common major changes in coagulation immediately after delivery of the newborn during Cesarean (C) -section and vaginal birth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2025
CompletedMarch 21, 2024
March 1, 2024
1.5 years
July 26, 2023
March 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of Hyperfibrinolysis
Ly30-Index is used as marker for Hyperfibrinolysis
immediate after birth
D-dimer
D-dimer level
immediate after birth
Study Arms (2)
cesarean section
maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined: * Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin) * Level of hs-D-Dimer SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine.
vaginal delivery
maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined: * Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin) * Level of hs-D-Dimer SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine.
Interventions
Coagulation tests named earlier as well as SpHb
Eligibility Criteria
780 women after giving birth to a child, 390 in each group
You may qualify if:
- Women aged 18 years and older with a singleton or multiple pregnancy who volunteer for the present study and give one blood sample of 6ml
You may not qualify if:
- Age \< 18 years
- Emergency cesarean section
- History of thrombocytopathy or coagulation disorders
- Therapy with drugs that influence thrombocyte function and coagulation (ASS less than 5 days ago, clopidogrel, prasugrel, ticagrelor or similar)
- Lack of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, Styria, 8010, Austria
Related Publications (1)
Zoidl P, Honnef G, Eichinger M, Eichlseder M, Heuschneider L, Hammer S, Schreiber N, Pruller F, Weiss EC, Amtmann B, Bornemann-Cimenti H. Hyperfibrinolysis During Caesarean Section and Vaginal Delivery: A Prospective Cross-Sectional Study in the Delivery Room. J Clin Med. 2025 Dec 20;15(1):27. doi: 10.3390/jcm15010027.
PMID: 41517278DERIVED
Biospecimen
one blood sample of 6ml
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2023
First Posted
August 3, 2023
Study Start
June 1, 2023
Primary Completion
November 30, 2024
Study Completion
April 17, 2025
Last Updated
March 21, 2024
Record last verified: 2024-03