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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01881698
Other study ID # 1426/2013
Secondary ID
Status Recruiting
Phase N/A
First received May 17, 2013
Last updated October 10, 2013
Start date October 2013
Est. completion date May 2015

Study information

Verified date October 2013
Source Medical University of Vienna
Contact Reinhard Hahn, MD
Phone 0043 1 40400
Email reinhard.hahn@meduniwien.ac.at
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational [Patient Registry]

Clinical Trial Summary

Establishment of a range of normal values in pregnancy with the Multiple Electrode Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet count but platelet function. This has not been studied in ths special patient group. Results from this trial will be used as a basis for further investigation of abnormal platelet function in pregnancy.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- pregnancy

Exclusion Criteria:

- Rejection of informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) device
Observation of platelet function in pregnancy

Locations

Country Name City State
Austria Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of platelet function Measurement of change of platelet function by the Multiplate® device. First measurement (baseline measurement) at enrollment into the trial. Second measurement during government-mandated gynaecological evaluation, around the 20th week of pregnancy.
Third measurement immediately prior to delivery. Last measurement one week after delivery. 2nd, 3rd and 4th measurement for assessment of change from baseline.
4x, as specified below No
Secondary Platelet-associated complications Record of bleeding events, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome.
Time points: at every assessment of primary outcome measure, as described above.
4x, as specified below (baseline, 20th week) No
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