Clinical trial NCT04777097: Blood Loss and Preeclampsia
Official title: Does Preeclampsia Affect Blood Loss During a Caesarean Procedure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-Eclampsia; Complicating Pregnancy
Blood Loss
Coagulation Disorder
Keywords: Pre-eclampsia
blood-loss
impaired coagulation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pre-eclampsia planed for cesarean section vs. healty pregnant women, planmned for cesarean section

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.

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

Primary outcomes:
measure: Blood-Loss
timeFrame: day 1
Secondary outcomes:
measure: Coagulation parameter
timeFrame: day 1
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institute for Anesthesiology
Study officials:
affiliation: Institut of Anesthesiology University Hospital Zurich
name: Marco P Zalunardo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.