Clinical trial NCT02993744: Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
Official title: Assessment of Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone Under Threat of Preterm Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: preterm birth
corticosteroids
inflammatory parameters
betamethasone
leukocytes
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman admitted to the department of feto-maternal health and obstetrics

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.

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.

Eligibility 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

Primary outcomes:
measure: CRP
timeFrame: 48h
Secondary outcomes:
measure: Leucocytes
timeFrame: 48h
Other outcomes:
measure: Body Mass Index (BMI)
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
measure: Weight
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
measure: Height
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
measure: CRP Control Group
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
measure: Leucocytes Control Group
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
measure: Patients with Allergies
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
measure: Patients with Diabetes
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
measure: Smoking Habits
timeFrame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
Locations:
city: Vienna
country: Austria
facility: General Hospital Vienna
Study officials:
affiliation: Medical University Vienna
name: Maria Kastanek
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Vienna
name: Florian Frommlet, DI. Dr.
role: STUDY_CHAIR
References: