Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

May 25, 2017 updated by: Kastanek Maria, Medical University of Vienna

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • General hospital Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant woman admitted to the department of feto-maternal health and obstetrics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CRP
Time Frame: 48h
The CRP values in mg/dL before and 48h after the first Betamethasone application
48h

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Leucocytes
Time Frame: 48h
The Leucocyte values in G/L before and 48h after the first Betamethasone application
48h

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
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)
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
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)
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
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
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
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
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
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)
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
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)
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
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)
single point in the time frame between week of gestation 23+0 - 34+6, no fixed day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Kastanek, Medical University Vienna
  • Study Chair: Florian Frommlet, DI. Dr., Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2130/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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