Clinical trial NCT03007186: Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes, Gestational
Insulin Sensitivity
PreTerm Birth
Glucose Intolerance During Pregnancy
Glucocorticoids
Keywords: Blood glucose monitoring
Glucose tolerance
HbA1C
Insulin
Betamethasone
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Blood glucose measurements
timeFrame: Seven days after betamethasone medication.
Secondary outcomes:
measure: HbA1C
timeFrame: One week after the medication with Betamethasone for lung maturation.
measure: Blood Glucose Level
timeFrame: One week after the medication with Betamethasone for lung maturation.
measure: Insulin level
timeFrame: One week after the medication with Betamethasone for lung maturation.
Other outcomes:
measure: Age of the patient in years
timeFrame: At the day of the medication with betamethasone
measure: Result of oral glucose tolerance test
timeFrame: The test will be carried out during pregnancy between 24+0 and 28+0 weeks of gestation
Locations:
city: Vienna
country: Austria
facility: AKH (General Hospital of) Vienna
Study officials:
affiliation: AKH Vienna
name: Christian Goebl, MD
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Lara Linsenmeier, Student
role: PRINCIPAL_INVESTIGATOR
References: