Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

NCT ID: NCT02993744

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Control Group

65 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, no threatening preterm delivery

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kastanek Maria

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria Kastanek

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Florian Frommlet, DI. Dr.

Role: STUDY_CHAIR

Medical University Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

General Hospital Vienna

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2130/2015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effectiveness of ACS in Extreme Preemies
NCT02351310 WITHDRAWN PHASE3