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Trial record 19 of 277 for:    Betamethasone

Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

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ClinicalTrials.gov Identifier: NCT02993744
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Kastanek Maria, Medical University of Vienna

Tracking Information
First Submitted Date December 7, 2016
First Posted Date December 15, 2016
Last Update Posted Date May 30, 2017
Actual Study Start Date September 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2016)
CRP [ Time Frame: 48h ]
The CRP values in mg/dL before and 48h after the first Betamethasone application
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02993744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 14, 2016)
Leucocytes [ Time Frame: 48h ]
The Leucocyte values in G/L before and 48h after the first Betamethasone application
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 14, 2016)
  • Body Mass Index (BMI) [ Time Frame: 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)
  • Weight [ Time Frame: 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)
  • Height [ Time Frame: 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)
  • CRP Control Group [ Time Frame: 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
  • Leucocytes Control Group [ Time Frame: 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
  • Patients with Allergies [ Time Frame: 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)
  • Patients with Diabetes [ Time Frame: 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)
  • Smoking Habits [ Time Frame: 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
Official Title Assessment of Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone Under Threat of Preterm Delivery
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
- blood samples
Sampling Method Non-Probability Sample
Study Population Pregnant woman admitted to the department of feto-maternal health and obstetrics
Condition Preterm Birth
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 17, 2017)
140
Original Estimated Enrollment
 (submitted: December 14, 2016)
130
Actual Study Completion Date May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT02993744
Other Study ID Numbers 2130/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kastanek Maria, Medical University of Vienna
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Principal Investigator: Maria Kastanek Medical University Vienna
Study Chair: Florian Frommlet, DI. Dr. Medical University Vienna
PRS Account Medical University of Vienna
Verification Date May 2017