Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Aarhus
About this trial
In case of threatening preterm birth, it is standard to recommend treatment with betamethasone to accelerate fetal lung maturation. In pregnant women with diabetes, treatment with betamethasone can lead to significant hyperglycemia, which may cause hypoglycemia in the neonate. Changes in blood glucose in non-diabetic women are less investigated. In this study we aim to examine changes in maternal blood glucose levels in non-diabetic women, during treatment with betamethasone, by continuous glucose monitoring.
Hypotheses:
Administration of betamethasone induce significant hyperglycemia in non-diabetic pregnant women during treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Multiple pregnancy
Diabetes
Pre-existing maternal use of medications that affect glucose metabolism
Trial population
Pregnant women admitted with symptoms of threatened preterm birth in gestational week 24+0 - 34+0
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Maternal blood glucose levels before, under and after the administration of betamethasone
Blood glucose levels (mmol/L) will be measured continuously using a continuous glucose monitor including a small electrode under the skin
Time frame
7-14 daysSecondary outcomes
1
The level of insulin (pmol/L)in maternal blood before, during, and after the effect of betamethasone
Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.
Time frame
7 days. From the day betamethasone is given untill 6 days after the first dose2
The level of 3-hydroxybuturat (mmol/L) in maternal blood before, during and after treatment with Betamethasone
Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.
Time frame
7 days. From the day betamethasone is given untill 6 days after the first dose3
Level of leukocytes (White blood cell count) (mia/L) in maternal blood before, during and after treatment with betamethasone
Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.
Time frame
7 days, from day one (the day where the first dose of betamethasone is given) untill 6 days after the first dose.4
The level of CRP (C-reactive protein)(nmol/ml) in maternal blood before, during and after treatment with betamethasone
Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.
Time frame
7 days. From the day betamethasone is given untill 6 days after the first dose.Sponsors and contacts
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Source ClinicalTrials.gov