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NCT04777097 Clinical Trial

Blood Loss and Preeclampsia

Blood Loss Clinical Trial

Official title:
Does Preeclampsia Affect Blood Loss During a Caesarean Procedure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04777097
Other study ID # 2020-00123
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date February 28, 2025

Study information
Verified date December 2023
Source University of Zurich
Contact Marco P Zalunardo, Prof
Phone +41442552695
Email marco.zalunardo@usz.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study of blood loss in preeclamptic patients using mathematical formulae

Description:

Pre-eclampsia is a symptom complex that occurs in 2-5% of all pregnancies and leads to significant morbidity and mortality. It is associated with a risk of impaired coagulation caused by a reduced platelet count, very rarely by disseminated intravascular coagulation disorders. The degree of clotting correlates with the severity of preeclampsia. It is planned to calculate the blood loss using mathematical formulas and to compare the different blood loss in the two groups (preeclampsia vs. healthy pregnant women). Furthermore, this project will try to correlate the blood loss with the underlying coagulation situation. The aim is to be able to better assess the bleeding risk in healthy pregnant women, but also in pre-eclamptic patients in the future.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Elective or urgent caesarean section - Written informed consent Exclusion Criteria: - Emergency caesarean section - Familial coagulation disorder - Hematological disorders that affect the platelet count, e.g. myelodysplastic syndrome (MDS) - Taking anticoagulants - Taking aspirin in the last 14 days - Use of NSARs in the last 24 hours

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample
Two blood sample will be drawn. On the day of operation and the first postoperative day.

Locations
Country Name City State
Switzerland University Hospital Zurich, Institute for Anesthesiology Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x. — View Citation

de Lange NM, Lance MD, de Groot R, Beckers EA, Henskens YM, Scheepers HC. Obstetric hemorrhage and coagulation: an update. Thromboelastography, thromboelastometry, and conventional coagulation tests in the diagnosis and prediction of postpartum hemorrhage — View Citation

Theusinger OM, Kind SL, Seifert B, Borgeat L, Gerber C, Spahn DR. Patient blood management in orthopaedic surgery: a four-year follow-up of transfusion requirements and blood loss from 2008 to 2011 at the Balgrist University Hospital in Zurich, Switzerlan — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Blood-Loss Corelation between blood loss and coagulation parameters will be calculated day 1
Secondary Coagulation parameter Impact of pre-eclampsia on the coagulation parameters day 1
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