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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03007186
Enrollment
36
Registered
2017-01-02
Start date
2016-10-31
Completion date
2017-07-31
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational, Glucocorticoids, Glucose Intolerance During Pregnancy, Insulin Sensitivity, PreTerm Birth

Keywords

Blood glucose monitoring, Glucose tolerance, HbA1C, Insulin, Betamethasone

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.

Interventions

None listed

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood glucose measurementsSeven 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

MeasureTime frameDescription
HbA1COne week after the medication with Betamethasone for lung maturation.HbA1C measurements from a blood draw of the patient.
Blood Glucose LevelOne week after the medication with Betamethasone for lung maturation.Blood glucose level measurements from a blood draw of the patient.
Insulin levelOne week after the medication with Betamethasone for lung maturation.Insulin level measurements from a blood draw of the patient.

Other

MeasureTime frameDescription
Age of the patient in yearsAt the day of the medication with betamethasoneAge of the patient in years
Result of oral glucose tolerance testThe test will be carried out during pregnancy between 24+0 and 28+0 weeks of gestationMandatory test in the Austrian Mother-Child-Pass. The data will be collected at the day of the medication with betamethasone.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026