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

NCT03007186 | Completed

• 1 other identifier: 1102/2016
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• HbA1C

  One week after the medication with Betamethasone for lung maturation.

• Blood Glucose Level

  One week after the medication with Betamethasone for lung maturation.

• Insulin level

  One week after the medication with Betamethasone for lung maturation.

Other Outcomes (2)

• Age of the patient in years

  At the day of the medication with betamethasone

• Result of oral glucose tolerance test

  The test will be carried out during pregnancy between 24+0 and 28+0 weeks of gestation

Study Arms (2)

Case group

The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements.

Control group

The oral glucose tolerance test of these women showed no pathological measurements.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

AKH (General Hospital of) Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance; Premature Birth

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Christian Goebl, MD

  AKH Vienna

  STUDY CHAIR

• Lara Linsenmeier, Student

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 2, 2017
• Study Start: October 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)