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

Glucose Monitoring During Threatening Preterm Birth With Particular Focus on Insulin Sensitivity and Glucose Tolerance in Patients With and Without Gestational Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity; Diabetes, Gestational; PreTerm Birth; Glucose Intolerance During Pregnancy; Glucocorticoids

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • AKH (General Hospital of) Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All participating patients will be pregnant women with a threatening preterm birth admitted to the department of feto-maternal health and obstetrics of the AKH Vienna.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Case group; The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements.
Control group; The oral glucose tolerance test of these women showed no pathological measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose measurements	The patient measures their blood glucose level six times a day for seven days. The times of the measurements are before and one hour after every meal.	Seven days after betamethasone medication.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C	HbA1C measurements from a blood draw of the patient.	One week after the medication with Betamethasone for lung maturation.
Blood Glucose Level	Blood glucose level measurements from a blood draw of the patient.	One week after the medication with Betamethasone for lung maturation.
Insulin level	Insulin level measurements from a blood draw of the patient.	One week after the medication with Betamethasone for lung maturation.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of the patient in years	Age of the patient in years	At the day of the medication with betamethasone
Result of oral glucose tolerance test	Mandatory test in the Austrian Mother-Child-Pass. The data will be collected at the day of the medication with betamethasone.	The test will be carried out during pregnancy between 24+0 and 28+0 weeks of gestation

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Chair: Christian Goebl, MD, AKH Vienna; Principal Investigator: Lara Linsenmeier, Student, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Insulin; Blood glucose monitoring; Glucose tolerance; HbA1C; Betamethasone
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Endocrine System Diseases; Hyperinsulinism; Pregnancy Complications; Obstetric Labor Complications; Hyperglycemia; Obstetric Labor, Premature; Hypersensitivity; Diabetes Mellitus; Glucose Intolerance; Premature Birth; Insulin Resistance; Diabetes, Gestational
• Other Study ID Numbers: 1102/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO