Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation

NCT06794307 | Recruiting

• 1 other identifier: 2024_VB_CGM
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm Birth; Hyperglycemia; Neonatal Hypoglycemia; Threatened Preterm Labor

Keywords

Preterm birth; Betamethasone; Continuous glucose monitoring; Antenatal corticosteroids

Outcome Measures

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

  7-14 days

Secondary Outcomes (10)

• The level of insulin (pmol/L)in maternal blood before, during, and after the effect of betamethasone

  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

  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

  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

  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

  At delivery of the baby

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women admitted with symptoms of threatened preterm birth in gestational week 24+0 - 34+0

You may qualify if:

• 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.
• Age over 18 years
• Read and understand Danish

You may not qualify if:

• Multiple pregnancy
• Diabetes
• Pre-existing maternal use of medications that affect glucose metabolism

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Region Denmark, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, umbilical cord blood, urine

MeSH Terms

Conditions

Premature Birth; Hyperglycemia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Victoria Bøttker

CONTACT

+45 21253835; victoria.boettker@gmail.com

Puk Sandager, MD, PhD

CONTACT

24216026; kirssand@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: January 27, 2025
• Study Start: November 20, 2024
• Primary Completion: October 30, 2025
• Study Completion: January 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)