Actively Recruiting

Age: 18Years +
FEMALE
ID06794307

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Multiple pregnancy
  • Diagnosed with diabetes
  • Pre-existing use of medications affecting glucose metabolism

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Monitoring

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

Long-term Monitoring

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

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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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