Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Platelet Function in Pregnancy With Multiple Electrode Aggregometry (MULPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881698
Recruitment Status : Unknown
Verified October 2013 by Reinhard Hahn, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
Reinhard Hahn, Medical University of Vienna

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Platelet Function Pregnancy Other: Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) device

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Months
Official Title: Multiple Electrode Aggregometry and Platelet Function in Pregnancy
Study Start Date : October 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change of platelet function [ Time Frame: 4x, as specified below ]

    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.



Secondary Outcome Measures :
  1. Platelet-associated complications [ Time Frame: 4x, as specified below (baseline, 20th week) ]

    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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients above the age of majority
Criteria

Inclusion Criteria:

  • pregnancy

Exclusion Criteria:

  • Rejection of informed consent
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881698


Contacts
Layout table for location contacts
Contact: Reinhard Hahn, MD 0043 1 40400 ext 4100 reinhard.hahn@meduniwien.ac.at
Contact: Albert M de Bettignies 0043 1 40400 n0826451@students.meduniwien.ac.at

Locations
Layout table for location information
Austria
Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien Recruiting
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Reinhard Hahn, MD Department of Anaesthesia, General Intensive Care and Pain Management, Medical University Vienna
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Layout table for additonal information
Responsible Party: Reinhard Hahn, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01881698     History of Changes
Other Study ID Numbers: 1426/2013
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013
Keywords provided by Reinhard Hahn, Medical University of Vienna:
pregnancy
platelet function
monitoring
multiple electrode aggregometry