Blood Loss and Preeclampsia | NCT04777097

Studies
Blood Loss and Preeclampsia

NCT04777097

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Dec 5, 2023Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Pre-Eclampsia; Complicating Pregnancy
Blood Loss
Coagulation Disorder

Interventions

Blood sample

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Feb 28, 2025Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Mar 1, 2021

First Posted Date

Mar 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2023

Last Update Posted Date

Dec 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other	Two blood sample will be drawn. On the day of operation and the first postoperative day.	Pre-eclampsia healthy pregnant women

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marco P Zalunardo, Prof	Contact	+41442552695		marco.zalunardo@usz.ch
Donat R Spahn, Prof	Contact	+41442552695		donat.spahn@usz.ch

Overall Officials

Name	Affiliation	Role
Marco P Zalunardo	Institut of Anesthesiology University Hospital Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Institute for Anesthesiology	Recruiting	Zurich		8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9354828	Result	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.
24931841	Result	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.

ID	Term
D011225	Pre-Eclampsia
D011248	Pregnancy Complications
D006470	Hemorrhage
D020141	Hemostatic Disorders

ID	Term
D046110	Hypertension, Pregnancy-Induced
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D010335	Pathologic Processes

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis