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NCT Number: NCT03007186

Glucose Monitoring During Threatening Preterm Birth 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.

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Key information

Conditions

Diabetes, Gestational Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucocorticoids Glucose Intolerance During Pregnancy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

AKH (General Hospital of) Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood glucose measurements

    Time frame: Seven days after betamethasone medication.

    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.

Secondary outcomes

  1. HbA1C

    Time frame: One week after the medication with Betamethasone for lung maturation.

    HbA1C measurements from a blood draw of the patient.

  2. Blood Glucose Level

    Time frame: One week after the medication with Betamethasone for lung maturation.

    Blood glucose level measurements from a blood draw of the patient.

  3. Insulin level

    Time frame: One week after the medication with Betamethasone for lung maturation.

    Insulin level measurements from a blood draw of the patient.

Other outcomes

  1. Age of the patient in years

    Time frame: At the day of the medication with betamethasone

    Age of the patient in years

  2. Result of oral glucose tolerance test

    Time frame: The test will be carried out during pregnancy between 24+0 and 28+0 weeks of gestation

    Mandatory test in the Austrian Mother-Child-Pass. The data will be collected at the day of the medication with betamethasone.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 2, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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