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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

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
Preterm Birth

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.


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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 : September 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017


Group/Cohort
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



Primary Outcome Measures :
  1. CRP [ Time Frame: 48h ]
    The CRP values in mg/dL before and 48h after the first Betamethasone application


Secondary Outcome Measures :
  1. Leucocytes [ Time Frame: 48h ]
    The Leucocyte values in G/L before and 48h after the first Betamethasone application


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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)


Biospecimen Retention:   None Retained
- blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant woman admitted to the department of feto-maternal health and obstetrics
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


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): NCT02993744


Locations
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Austria
General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Maria Kastanek Medical University Vienna
Study Chair: Florian Frommlet, DI. Dr. Medical University Vienna

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Responsible Party: Kastanek Maria, Student, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02993744     History of Changes
Other Study ID Numbers: 2130/2015
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kastanek Maria, Medical University of Vienna:
preterm birth
corticosteroids
inflammatory parameters
betamethasone
leukocytes
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents