Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia
1 other identifier
observational
60
0 countries
N/A
Brief Summary
The study aims to investigate the impact of preeclampsia on hemostasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2017
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedAugust 22, 2017
August 1, 2017
4 months
May 3, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry
ADP induced platelet aggregation
Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study
Secondary Outcomes (3)
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
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
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
Study Arms (3)
Pregnant Preeclampsia
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
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
Control group 2 Healthy and not pregnant control group Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling.
Interventions
Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)
Eligibility Criteria
Pregnant patients suffering from preeclampsia, n = 20 Control group 1: Healthy pregnant patients, not suffering from preeclampsia, n=20 Control group 2: Healthy woman (age between 18 and 40y) that are not pregnant
You may qualify if:
- Platelet count \> 100 / nll
- In study group and control group 1: Week of Pregnancy: 35-40
- in control group 2: healthy, not pregnant woman
You may not qualify if:
- Hereditary coagulopathy
- Missing content of the patient / proband
- Eclampsia
- HELLP syndrome
- CRP \> 1 mg/dl
- Fever (\> 38°C)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian F Weber, MD, PhD
Goethe University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Christian F. Weber
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 11, 2017
Study Start
September 1, 2017
Primary Completion
December 31, 2017
Study Completion
February 1, 2018
Last Updated
August 22, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share