NCT02993744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

December 7, 2016

Last Update Submit

May 25, 2017

Conditions

Preterm Birth

Keywords

preterm birthcorticosteroidsinflammatory parametersbetamethasoneleukocytes

Outcome Measures

Primary Outcomes (1)

  • CRP

    The CRP values in mg/dL before and 48h after the first Betamethasone application

    48h

Secondary Outcomes (1)

  • Leucocytes

    48h

Other Outcomes (8)

  • Body Mass Index (BMI)

    single point in the time frame between week of gestation 23+0 - 34+6, no fixed day

  • Weight

    single point in the time frame between week of gestation 23+0 - 34+6, no fixed day

  • Height

    single point in the time frame between week of gestation 23+0 - 34+6, no fixed day

  • +5 more other outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant woman admitted to the department of feto-maternal health and obstetrics

You may qualify if:

  • week of gestation 23+0 until 34+6

You may not qualify if:

  • infectious diseases f.e. hepatitis B or C, HIV
  • diseases of the thyroid gland
  • Patients facing preterm labour 65 Patients acting as a control group, without preterm labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: NONE RETAINED

\- blood samples

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Maria Kastanek

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

  • Florian Frommlet, DI. Dr.

    Medical University Vienna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 15, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)