Blood Loss and Preeclampsia

Does Preeclampsia Affect Blood Loss During a Caesarean Procedure

Study of blood loss in preeclamptic patients using mathematical formulae

Study Overview

• Status: Recruiting
• Conditions: Blood Loss; Coagulation Disorder; Pre-Eclampsia; Complicating Pregnancy
• Intervention / Treatment: Other: Blood sample

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Marco P Zalunardo, Prof; Phone Number: +41442552695; Email: marco.zalunardo@usz.ch
• Study Contact Backup: Name: Donat R Spahn, Prof; Phone Number: +41442552695; Email: donat.spahn@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich, Institute for Anesthesiology
    • Contact: Marco P Zalunardo, Prof; Phone Number: +41442552695; Email: marco.zalunardo@usz.ch
    • Contact: Donat R Spahn, Prof; Phone Number: +41442552695; Email: donat.spahn@usz.ch
    • Sub-Investigator: Martin Schläpfer, PD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with pre-eclampsia planed for cesarean section vs. healty pregnant women, planmned for cesarean section

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy pregnant women; Healthy patients who receive a cesarean operation	Other: Blood sample; Two blood sample will be drawn. On the day of operation and the first postoperative day.
Pre-eclampsia; Patients with pre-eclampsia who receive a caesarean operation	Other: Blood sample; Two blood sample will be drawn. On the day of operation and the first postoperative day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood-Loss	Corelation between blood loss and coagulation parameters will be calculated	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coagulation parameter	Impact of pre-eclampsia on the coagulation parameters	day 1

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Marco P Zalunardo, Institut of Anesthesiology University Hospital Zurich

Publications and helpful links

General Publications

• 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.
• 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, Switzerland. Blood Transfus. 2014 Apr;12(2):195-203. doi: 10.2450/2014.0306-13.
• 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. Obstet Gynecol Surv. 2012 Jul;67(7):426-35. doi: 10.1097/OGX.0b013e3182605861.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pre-eclampsia; blood-loss; impaired coagulation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Eclampsia; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: 2020-00123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No