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NCT Number: NCT06794307

Blood Glucose 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Central Region Denmark, 8200, Denmark

Location status: Recruiting

Location contact

Per Glud Ovesen, MD, DMSci

SUB_INVESTIGATOR

Per Glud Ovesen, MD, DMSci, Professor

CONTACT

[email protected]

0045 +´61669728 /78453315

Puk Sandager, MD, PhD

SUB_INVESTIGATOR

Puk Sandager, MD, Phd

CONTACT

[email protected]

0045 + 24216026

Victoria Bøttker, Medical student

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.

  2. 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

    Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.

  3. 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.

    Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.

  4. 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.

    Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.

  5. The level of glucose (mmol/L) in umbilical cord blood at delivery

    Time frame: At delivery of the baby

    After the birth and cord occlusion a blood sample will be drawn from the umbilical cord

  6. The level of insulin (pmol/L) in umbilical cord blood at delivery

    Time frame: At delivery

    After the birth and cord occlusion a blood sample will be drawn from the umbilical cord

  7. The level of c-peptid (pmol/L) in umbilical cord blood at delivery

    Time frame: At delivery

    After the birth and cord occlusion a blood sample will be drawn from the umbilical cord

  8. The level af adiponectin (ug/ml) in umbilical cord blood at delivery

    Time frame: At delivery

    After the birth and cord occlusion a blood sample will be drawn from the umbilical cord

  9. The level of leptin (ng/ml) in umbilical cord blood at delivery

    Time frame: At delivery

    After the birth and cord occlusion a blood sample will be drawn from the umbilical cord

  10. Number of infants with need for early feeding (yes/no) after birth

    Time frame: First two days after birth

    Information from files on whether the infant was given "Early feeding" after delivery (yes/no)

Study contacts

Contact information is provided by the study sponsor or research team.

Puk Sandager, MD, PhD

CONTACT

[email protected]

24216026

Victoria Bøttker

CONTACT

[email protected]

+45 21253835

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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