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

Completed

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

• Registration Number: NCT03007186
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2017-01-02
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood glucose measurements	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 Outcome Measures

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

Trial Locations

Locations (1)

AKH (General Hospital of) Vienna; 🇦🇹 Vienna, Austria