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

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements. | |
| Control group<br>The oral glucose tolerance test of these women showed no pathological measurements. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C | HbA1C measurements from a blood draw of the patient. | One week after the medication with Betamethasone for lung maturation. | 
| Blood Glucose Level | Blood glucose level measurements from a blood draw of the patient. | One week after the medication with Betamethasone for lung maturation. | 
| Insulin level | Insulin level measurements from a blood draw of the patient. | One week after the medication with Betamethasone for lung maturation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose monitoring, Glucose tolerance, HbA1C, Insulin, Betamethasone