Blood Loss and Preeclampsia

Recruiting

• Conditions: Blood Loss; Coagulation Disorder; Pre-Eclampsia; Complicating Pregnancy
• Interventions: Other: Blood sample

• Registration Number: NCT04777097
• Lead Sponsor: University of Zurich

Brief Summary

Study of blood loss in preeclamptic patients using mathematical formulae

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy pregnant women	Blood sample	Healthy patients who receive a cesarean operation
Pre-eclampsia	Blood sample	Patients with pre-eclampsia who receive a caesarean operation

Primary Outcome Measures

Name	Time	Method
Blood-Loss	day 1	Corelation between blood loss and coagulation parameters will be calculated

Secondary Outcome Measures

Name	Time	Method
Coagulation parameter	day 1	Impact of pre-eclampsia on the coagulation parameters

Trial Locations

Locations (1)

University Hospital Zurich, Institute for Anesthesiology; 🇨🇭 Zurich, Switzerland