NCT04777097

Brief Summary

Study of blood loss in preeclamptic patients using mathematical formulae

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

4.2 years

First QC Date

February 25, 2021

Last Update Submit

December 4, 2023

Conditions

Keywords

Pre-eclampsiablood-lossimpaired coagulation

Outcome Measures

Primary Outcomes (1)

  • Blood-Loss

    Corelation between blood loss and coagulation parameters will be calculated

    day 1

Secondary Outcomes (1)

  • Coagulation parameter

    day 1

Study Arms (2)

healthy pregnant women

Healthy patients who receive a cesarean operation

Other: Blood sample

Pre-eclampsia

Patients with pre-eclampsia who receive a caesarean operation

Other: Blood sample

Interventions

Two blood sample will be drawn. On the day of operation and the first postoperative day.

Pre-eclampsiahealthy pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Elective or urgent caesarean section
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Institute for Anesthesiology

Zurich, 8091, Switzerland

RECRUITING

Related 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Pre-EclampsiaPregnancy ComplicationsHemorrhageHemostatic Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marco P Zalunardo

    Institut of Anesthesiology University Hospital Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco P Zalunardo, Prof

CONTACT

Donat R Spahn, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 2, 2021

Study Start

January 1, 2021

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations