NCT01881698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

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 17, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

May 17, 2013

Last Update Submit

October 10, 2013

Conditions

Platelet FunctionPregnancy

Keywords

pregnancyplatelet functionmonitoringmultiple electrode aggregometry

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Platelet-associated complications

    4x, as specified below (baseline, 20th week)

Interventions

Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) deviceOTHER

Observation of platelet function in pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients above the age of majority

You may qualify if:

  • pregnancy

You may not qualify if:

  • Rejection of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien

Vienna, Vienna, 1090, Austria

RECRUITING

Study Officials

  • Reinhard Hahn, MD

    Department of Anaesthesia, General Intensive Care and Pain Management, Medical University Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinhard Hahn, MD

CONTACT

0043 1 40400reinhard.hahn@meduniwien.ac.at

Albert M de Bettignies

CONTACT

0043 1 40400n0826451@students.meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2013

First Posted

June 20, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

AU(1)