Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia

• Conditions: Coagulation Disorder, Blood; Platelet Function
• Interventions: Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasis

• Registration Number: NCT03149250
• Lead Sponsor: Goethe University

Brief Summary

The study aims to investigate the impact of preeclampsia on hemostasis.

Detailed Description

In comparison to healthy pregnant women and non-pregnant woman, this study analyses parameters of primary hemostasis and plasmatic coaguation in preeclamptic pregnant woman. Detailed analyses of the platelet function is performed using the Multiple Electrode Aggregometry, detailed analyses of the plasmatic coagulation syste is performed by isolated coaguation factor analyses and conventional coagulation analyses.

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22
• Study Start: 2017-09-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Platelet count > 100 / nll
• In study group and control group 1: Week of Pregnancy: 35-40
• in control group 2: healthy, not pregnant woman

Exclusion Criteria

• Hereditary coagulopathy
• Missing content of the patient / proband
• Eclampsia
• HELLP syndrome
• CRP > 1 mg/dl
• Fever (> 38°C)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Preeclampsia	Aggregometry, Monitoring of plasmatic hemostasis	Pregnant between 35th and 40th week of pregnancy Preeclampisa Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling in the context of routinely performed blood sampling
Pregnant No-Preeclampsia	Aggregometry, Monitoring of plasmatic hemostasis	Control Group 1 Pregnant between 35th and 40th week of pregnancy No Preeclampsia Healthy Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling in the context of routinely performed blood sampling
Not Pregnant	Aggregometry, Monitoring of plasmatic hemostasis	Control group 2 Healthy and not pregnant control group Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling.

Primary Outcome Measures

Name	Time	Method
Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study	ADP induced platelet aggregation

Secondary Outcome Measures

Name	Time	Method
Area under the aggregation curve in the ASPItest of the Multiple Electrode Aggregometry	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study	Arachidonic acid induced platelet aggregation
Area under the aggregation curve in the TRAPtest of the Multiple Electrode Aggregometry	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study	Thrombin induced platelet aggregation
Parameters of plasmatic coagulation system	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study	von Willebrand Factor, Factor VIII, Factor XIII, parameter of conventional coagulation testing (apTT, INR, platelet count, Fibrinogen)