Preterm BirthNCT06794307
Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
An observational study of Preterm Birth and Hyperglycemia, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Hyperglycemia, Neonatal Hypoglycemia
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Nov 2024to Jan 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women admitted with symptoms of threatened preterm birth in gestational week 24+0 - 34+0
Who may be able to join
- Pregnant in gestational week 24+0 - 34+0 admitted with symptoms of threatened preterm birth:
- 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
Who cannot join
- Multiple pregnancy
- Diabetes
- Pre-existing maternal use of medications that affect glucose metabolism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Region Denmark, 8200
Puk Sandager, MD, Phd, 0045 + 24216026, kirssand@rm.dk
Per Glud Ovesen, MD, DMSci, Professor, 0045 +´61669728 /78453315, perovese@rm.dk
About this study
Official title: Blood Glucose Levels in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
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.
Read the detailed description
Antenatal corticosteroid administration is an important treatment to reduce the incidence of neonatal respiratory distress syndrome, and improve neonatal outcomes of babies born premature.
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.
- Keywords
- Preterm birth, Betamethasone, Continuous glucose monitoring, Antenatal corticosteroids
- Medical subject headings
- Premature Birth, Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7-14 days
Secondary outcomes (10)
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.
Measured: 7 days. From the day betamethasone is given untill 6 days after the first dose
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.
Measured: 7 days. From the day betamethasone is given untill 6 days after the first dose
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.
Measured: 7 days, from day one (the day where the first dose of betamethasone is given) untill 6 days after the first dose.
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.
Measured: 7 days. From the day betamethasone is given untill 6 days after the first dose.
The level of glucose (mmol/L) in umbilical cord blood at delivery
After the birth and cord occlusion a blood sample will be drawn from the umbilical cord
Measured: At delivery of the baby
The level of insulin (pmol/L) in umbilical cord blood at delivery
After the birth and cord occlusion a blood sample will be drawn from the umbilical cord
Measured: At delivery
The level of c-peptid (pmol/L) in umbilical cord blood at delivery
After the birth and cord occlusion a blood sample will be drawn from the umbilical cord
Measured: At delivery
The level af adiponectin (ug/ml) in umbilical cord blood at delivery
After the birth and cord occlusion a blood sample will be drawn from the umbilical cord
Measured: At delivery
The level of leptin (ng/ml) in umbilical cord blood at delivery
After the birth and cord occlusion a blood sample will be drawn from the umbilical cord
Measured: At delivery
Number of infants with need for early feeding (yes/no) after birth
Information from files on whether the infant was given "Early feeding" after delivery (yes/no)
Measured: First two days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start20 Nov 2024
- Primary completion30 Oct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794307
- Sponsor's protocol ID
- 2024_VB_CGM
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan decided yet
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Levels in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
- ClinicalTrials.gov ID
- NCT06794307
- Acronym / sponsor ID
- 2024_VB_CGM
- Keywords
- Preterm birth, Betamethasone, Continuous glucose monitoring, Antenatal corticosteroids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Antenatal corticosteroid administration is an important treatment to reduce the incidence of neonatal respiratory distress syndrome, and improve neonatal outcomes of babies born premature.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women admitted with symptoms of threatened preterm birth in gestational week 24+0 - 34+0
Key inclusion criteria (6 listed)
- Pregnant in gestational week 24+0 - 34+0 admitted with symptoms of threatened preterm birth:
- Treatment with betamethasone for fetal lung maturation is planned, or started (maximum 4 hours before inclusion)
- Age over 18 years
- Read and understand Danish
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Diabetes
- Pre-existing maternal use of medications that affect glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal blood glucose levels before, under and after the administration of betamethasone
Time frame: 7-14 days
Blood glucose levels (mmol/L) will be measured continuously using a continuous glucose monitor including a small electrode under the skin
10 secondary outcomes
The level of insulin (pmol/L)in maternal blood before, during, and after the effect of betamethasone
Time frame: 7 days. From the day betamethasone is given untill 6 days after the first dose
The level of 3-hydroxybuturat (mmol/L) in maternal blood before, during and after treatment with Betamethasone
Time frame: 7 days. From the day betamethasone is given untill 6 days after the first dose
Level of leukocytes (White blood cell count) (mia/L) in maternal blood before, during and after treatment with betamethasone
Time frame: 7 days, from day one (the day where the first dose of betamethasone is given) untill 6 days after the first dose.
The level of CRP (C-reactive protein)(nmol/ml) in maternal blood before, during and after treatment with betamethasone
Time frame: 7 days. From the day betamethasone is given untill 6 days after the first dose.
The level of glucose (mmol/L) in umbilical cord blood at delivery
Time frame: At delivery of the baby
The level of insulin (pmol/L) in umbilical cord blood at delivery
Time frame: At delivery
The level of c-peptid (pmol/L) in umbilical cord blood at delivery
Time frame: At delivery
The level af adiponectin (ug/ml) in umbilical cord blood at delivery
Time frame: At delivery
The level of leptin (ng/ml) in umbilical cord blood at delivery
Time frame: At delivery
Number of infants with need for early feeding (yes/no) after birth
Time frame: First two days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No. No plan decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Hyperglycemia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Bøttker (+45 21253835, victoria.boettker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal blood glucose levels before, under and after the administration of betamethasone (time frame: 7-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.