Clinical trial NCT06794307: Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
Official title: Blood Glucose Levels in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Birth
Hyperglycemia
Neonatal Hypoglycemia
Threatened Preterm Labor
Keywords: Preterm birth
Betamethasone
Continuous glucose monitoring
Antenatal corticosteroids
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women admitted with symptoms of threatened preterm birth in gestational week 24+0 - 34+0

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal blood glucose levels before, under and after the administration of betamethasone
timeFrame: 7-14 days
Secondary outcomes:
measure: The level of insulin (pmol/L)in maternal blood before, during, and after the effect of betamethasone
timeFrame: 7 days. From the day betamethasone is given untill 6 days after the first dose
measure: The level of 3-hydroxybuturat (mmol/L) in maternal blood before, during and after treatment with Betamethasone
timeFrame: 7 days. From the day betamethasone is given untill 6 days after the first dose
measure: Level of leukocytes (White blood cell count) (mia/L) in maternal blood before, during and after treatment with betamethasone
timeFrame: 7 days, from day one (the day where the first dose of betamethasone is given) untill 6 days after the first dose.
measure: The level of CRP (C-reactive protein)(nmol/ml) in maternal blood before, during and after treatment with betamethasone
timeFrame: 7 days. From the day betamethasone is given untill 6 days after the first dose.
measure: The level of glucose (mmol/L) in umbilical cord blood at delivery
timeFrame: At delivery of the baby
measure: The level of insulin (pmol/L) in umbilical cord blood at delivery
timeFrame: At delivery
measure: The level of c-peptid (pmol/L) in umbilical cord blood at delivery
timeFrame: At delivery
measure: The level af adiponectin (ug/ml) in umbilical cord blood at delivery
timeFrame: At delivery
measure: The level of leptin (ng/ml) in umbilical cord blood at delivery
timeFrame: At delivery
measure: Number of infants with need for early feeding (yes/no) after birth
timeFrame: First two days after birth
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Region Denmark
Study officials:
References: