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Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02993744
Enrollment
140
Registered
2016-12-15
Start date
2016-09-30
Completion date
2017-05-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

preterm birth, corticosteroids, inflammatory parameters, betamethasone, leukocytes

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.

Interventions

None listed

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CRP48hThe CRP values in mg/dL before and 48h after the first Betamethasone application

Secondary

MeasureTime frameDescription
Leucocytes48hThe Leucocyte values in G/L before and 48h after the first Betamethasone application

Other

MeasureTime frameDescription
Heightsingle point in the time frame between week of gestation 23+0 - 34+6, no fixed daySize in meters (m) is taken from the medical record to calculate the BMI in both groups (case and control)
CRP Control Groupsingle point in the time frame between week of gestation 23+0 - 34+6, no fixed dayCRP values in mg/dL of patients belonging to the control group
Leucocytes Control Groupsingle point in the time frame between week of gestation 23+0 - 34+6, no fixed dayLeucocyte values in G/L of patients belonging to the control group
Body Mass Index (BMI)single point in the time frame between week of gestation 23+0 - 34+6, no fixed dayBody Mass Index (BMI) in kg/m\^2 is calculated to test for influence on inflammatory parameters in both groups (case and control)
Patients with Diabetessingle point in the time frame between week of gestation 23+0 - 34+6, no fixed dayinformation 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)
Smoking Habitssingle point in the time frame between week of gestation 23+0 - 34+6, no fixed dayinformation 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)
Patients with Allergiessingle point in the time frame between week of gestation 23+0 - 34+6, no fixed dayinformation 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)
Weightsingle point in the time frame between week of gestation 23+0 - 34+6, no fixed dayWeight in kilogram (kg) is taken from the medical record to calculate the BMI in both groups (case and control)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026