Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus

NCT ID: NCT03007186

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-07-31

Brief Summary

This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.

Detailed Description

BACKGROUND:

The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm birth is an long existing part of the obstetric routine procedures. Under this therapy it should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin sensitivity as well as they can cause an impaired maternal glucose tolerance.

Therefore a threatening preterm birth as well as the including medical therapy do challenge the glucose metabolism of mother and child.

Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy, and the numbers are on the rise. GDM is characterized through an insulin resistance during the pregnancy.

High blood glucose level during pregnancy or labour can cause complications like a fetal hypoglycaemia right after birth.

METHODS:

This study includes pregnant women with and without gestational diabetes who are medicated with betamethasone due to threatening preterm birth.

In this study the blood glucose measurements of one week, as well as the measurements of HbA1C, Insulin and Blood Glucose from a blood draw one week after the lung maturation therapy will be considered.

Conditions

Diabetes, Gestational; Insulin Sensitivity; PreTerm Birth; Glucose Intolerance During Pregnancy; Glucocorticoids

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group

The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements.

No interventions assigned to this group

Control group

The oral glucose tolerance test of these women showed no pathological measurements.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• female
• gestational age between 23+0 and 34+6
• an oral glucose tolerance test was made and attests a healthy glucose tolerance (control group) a gestational diabetes mellitus (case group)
• threatening preterm birth

Exclusion Criteria

• missing consent to participate
• age under 18 years
• age over 50 years
• preexistent diabetes (type 1 or 2)
• apparent disease of the thyroid gland
• infectious diseases as HIV or Hepatitis C
• insulin dependent gestational diabetes mellitus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Lara Linsenmeier

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Goebl, MD

Role: STUDY_CHAIR

AKH Vienna

Lara Linsenmeier, Student

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

AKH (General Hospital of) Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

1102/2016

Identifier Type: -

Identifier Source: org_study_id