Evaluation of Platelet Function in Pregnancy With Multiple Electrode Aggregometry

Pregnancy Clinical Trial

— MULPP  

Official title:

Multiple Electrode Aggregometry and Platelet Function in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01881698
• Other study ID #: 1426/2013
• 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

• Platelet Function
• Pregnancy

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