Actively Recruiting
Blood Glucose Levels in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
Led by University of Aarhus · Updated on 2025-01-27
25
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how betamethasone treatment affects blood sugar levels in pregnant women without diabetes who are at risk of preterm birth. Betamethasone is typically given to help mature the baby's lungs before an early delivery, but it can cause high blood sugar in mothers, especially those with diabetes. This study focuses on understanding blood sugar changes in non-diabetic pregnant women during this treatment using continuous glucose monitoring. Participants will receive betamethasone as part of their care for threatened preterm birth, either planned or already started within four hours before joining the study. Blood sugar levels will be closely tracked using a continuous glucose monitor over several days during and after the treatment. Blood samples will also be taken for various tests including insulin, inflammatory markers, and ketones. After birth, samples from the umbilical cord will be collected to measure factors related to blood sugar and inflammation. Information about newborn feeding and hypoglycemia will also be recorded. During the study, women will have regular blood tests for up to six days following betamethasone administration. Twice daily urine tests will check for glucose and ketones. The main focus is to observe changes in maternal blood sugar levels before, during, and after treatment. Researchers will also monitor several blood markers and newborn health indicators to better understand the effects of betamethasone. The study aims to improve care by identifying if blood sugar needs closer monitoring during this treatment to protect both mother and baby.
CONDITIONS
Brief Title
Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women between 24+0 and 34+0 weeks gestation with symptoms of threatened preterm birth
- Premature contractions with cervical shortening or preterm premature rupture of membranes
- Planned or started treatment with betamethasone for fetal lung maturation within 4 hours before inclusion
- Age over 18 years
- Able to read and understand Danish
You will not qualify if you...
- Multiple pregnancy
- Diagnosed with diabetes
- Pre-existing use of medications affecting glucose metabolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 7 days from the day betamethasone is given until 6 days after the first dose
Participants have their blood glucose levels continuously monitored during and after betamethasone treatment using a continuous glucose monitor. Blood and urine samples are collected to measure various biochemical markers related to glucose metabolism and inflammation.
Daily blood sample collection on days 1 to 6 and twice daily urine dipstick tests
Duration - Up to 2 days after birth
After delivery, participants' infants have blood samples taken from the umbilical cord to measure glucose and related markers. Information on infant hypoglycemia and early feeding needs is recorded.
1 visit at delivery and follow-up assessments within the first two days after birth
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Central Region Denmark, Denmark, 8200
Actively Recruiting
Research Team
V
Victoria Bøttker
P
Puk Sandager, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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