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Completed

NCT Number: NCT02993744

Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

General Hospital Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CRP

    Time frame: 48h

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

Secondary outcomes

  1. Leucocytes

    Time frame: 48h

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

Other outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Assessment of Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone Under Threat of Preterm Delivery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2016
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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