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Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02993744
Collaborator
(none)
140
Enrollment
1
Location
8
Actual Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is the aim of this study to detect the effect of Betamethasone on the maternal inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under threat of preterm delivery, for example because of a cervical infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    BACKGROUND

    Cortisone influences the maternal number of leukocytes and CRP of a pregnant woman. Because of that, it is difficult to know if the medical treatment of an infection was successful and accordingly if the diagnosis was justified.

    METHODS

    In this study, the blood results of 75 pregnant women under threat of preterm delivery (week of gestation 23+0 to 34+6), treated with Betamethasone will be analysed. 65 pregnant women without complications serve as control group.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone Under Threat of Preterm Delivery
    Actual Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    May 1, 2017
    Actual Study Completion Date :
    May 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Case Group

    75 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, threatening preterm delivery, application of Betamethasone
    Control Group

    65 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, no threatening preterm delivery

    Outcome Measures

    Primary Outcome Measures

    1. CRP [48h]

      The CRP values in mg/dL before and 48h after the first Betamethasone application

    Secondary Outcome Measures

    1. Leucocytes [48h]

      The Leucocyte values in G/L before and 48h after the first Betamethasone application

    Other Outcome Measures

    1. Body Mass Index (BMI) [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      Body Mass Index (BMI) in kg/m^2 is calculated to test for influence on inflammatory parameters in both groups (case and control)

    2. Weight [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      Weight in kilogram (kg) is taken from the medical record to calculate the BMI in both groups (case and control)

    3. Height [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      Size in meters (m) is taken from the medical record to calculate the BMI in both groups (case and control)

    4. CRP Control Group [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      CRP values in mg/dL of patients belonging to the control group

    5. Leucocytes Control Group [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      Leucocyte values in G/L of patients belonging to the control group

    6. Patients with Allergies [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      information about the patients allergie status (allergies yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)

    7. Patients with Diabetes [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      information about the patients diabetes status (diabetes yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)

    8. Smoking Habits [single point in the time frame between week of gestation 23+0 - 34+6, no fixed day]

      information about the patients smoking status (smoking yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • week of gestation 23+0 until 34+6
    Exclusion Criteria:

    • infectious diseases f.e. hepatitis B or C, HIV

    • diseases of the thyroid gland

    75 Patients facing preterm labour 65 Patients acting as a control group, without preterm labor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Maria Kastanek, Medical University Vienna
    • Study Chair: Florian Frommlet, DI. Dr., Medical University Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kastanek Maria, Student, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT02993744
    Other Study ID Numbers:
    • 2130/2015
    First Posted:
    Dec 15, 2016
    Last Update Posted:
    May 30, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Kastanek Maria, Student, Medical University of Vienna
    preterm birth
    corticosteroids
    inflammatory parameters
    betamethasone
    leukocytes
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of May 30, 2017