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Blood Loss and Preeclampsia

NCT ID: NCT04777097

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-02-28

Brief Summary

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Study of blood loss in preeclamptic patients using mathematical formulae

Detailed Description

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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.

Conditions

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Pre-Eclampsia; Complicating Pregnancy Blood Loss Coagulation Disorder

Keywords

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Pre-eclampsia blood-loss impaired coagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy pregnant women

Healthy patients who receive a cesarean operation

Blood sample

Intervention Type OTHER

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

Blood sample

Intervention Type OTHER

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

Interventions

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Blood sample

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco P Zalunardo

Role: PRINCIPAL_INVESTIGATOR

Institut of Anesthesiology University Hospital Zurich

Locations

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University Hospital Zurich, Institute for Anesthesiology

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Marco P Zalunardo, Prof

Role: CONTACT

Phone: +41442552695

Email: [email protected]

Donat R Spahn, Prof

Role: CONTACT

Phone: +41442552695

Email: [email protected]

Facility Contacts

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Marco P Zalunardo, Prof

Role: primary

Donat R Spahn, Prof

Role: backup

References

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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.

Reference Type RESULT
PMID: 9354828 (View on PubMed)

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.

Reference Type RESULT
PMID: 24931841 (View on PubMed)

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.

Reference Type RESULT
PMID: 22926249 (View on PubMed)

Other Identifiers

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2020-00123

Identifier Type: -

Identifier Source: org_study_id