Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993744
• Other study ID #: 2130/2015
• Status: Completed
• Phase: N/A
• First received: December 7, 2016
• Last updated: May 25, 2017
• Start date: September 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
Austria	General Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	CRP	The CRP values in mg/dL before and 48h after the first Betamethasone application	48h
Secondary	Leucocytes	The Leucocyte values in G/L before and 48h after the first Betamethasone application	48h