Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

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: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • General Hospital Vienna

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP	The CRP values in mg/dL before and 48h after the first Betamethasone application	48h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leucocytes	The Leucocyte values in G/L before and 48h after the first Betamethasone application	48h

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	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	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	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	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	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	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	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	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

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: preterm birth; corticosteroids; leukocytes; betamethasone; inflammatory parameters
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2130/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO