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

PreTerm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007186
• Other study ID #: 1102/2016
• Status: Completed
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Glucocorticoids
• Glucose Intolerance
• Glucose Intolerance During Pregnancy
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Premature Birth
• PreTerm Birth

Locations

Country	Name	City	State
Austria	AKH (General Hospital of) Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age of the patient in years	Age of the patient in years	At the day of the medication with betamethasone
Other	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
Primary	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	HbA1C	HbA1C measurements from a blood draw of the patient.	One week after the medication with Betamethasone for lung maturation.
Secondary	Blood Glucose Level	Blood glucose level measurements from a blood draw of the patient.	One week after the medication with Betamethasone for lung maturation.
Secondary	Insulin level	Insulin level measurements from a blood draw of the patient.	One week after the medication with Betamethasone for lung maturation.