Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
NCT ID: NCT06794307
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2024-11-20
2026-01-31
Brief Summary
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Hypotheses:
Administration of betamethasone induce significant hyperglycemia in non-diabetic pregnant women during treatment.
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Detailed Description
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Administration of betamethasone however also affects the maternal glucose homeostasis, and it is well-known that in pregnant women with diabetes, the administration of glucocorticoids can lead to significant maternal hyperglycemia, and hypoglycemia in the neonate, unless the insulin dosage is adjusted accordingly. Administration of betamethasone also affects the glucose homeostasis in pregnant non-diabetic women. However, only few studies have investigated the changes in the blood glucose levels in non-diabetic pregnant women, and a more accurate depiction of the glycemic response to betamethasone can be obtained by continuous glucose monitoring.
Recruitment of participants will occur upon their arrival with symptoms of threatened preterm birth, when it is decided to start treatment with betamethasone for fetal lung maturation.
To measure blood glucose levels in the pregnant women, a continuous glucose monitor (CGM) will be used.
Further, blood samples will be collected on days 1-6 after inclusion, for measurement of: Insulin, blood glucose, 3-hydroxybutyrat, HgbA1c, CRP and leucocytes.
Urine dipstick test for ketones and glucose will be performed twice daily. After delivery, a blood sample will be extracted from the umbilical cord for measurement of Ph, base-excess, glucose, insulin c-peptide and inflammatory markers.
Information on hypoglycemia and/or the need for early feeding of the infant after birth will be recorded.
Perspectives:
The results of this study will help us understand how the administration of betamethasone affects maternal blood glucose levels. If it is found, that administration of betamethasone causes significant hyperglycemia in the pregnant women, it may be important to measure and treat hyperglycemia during betamethasone treatment, to ensure the effect of betamethasone and prevent neonatal complications due to hypoglycemia.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Premature contractions and shortening of the cervix, or
* Preterm premature rupture of membranes.
* Treatment with betamethasone for fetal lung maturation is planned, or started (maximum 4 hours before inclusion)
* Age over 18 years
* Read and understand Danish
Exclusion Criteria
* Diabetes
* Pre-existing maternal use of medications that affect glucose metabolism
18 Years
FEMALE
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, Central Region Denmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024_VB_CGM
Identifier Type: -
Identifier Source: org_study_id
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