Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT06716918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
The Effect of Antenatal Corticosteroids Prior to Planned Cesarean Section in Early Term on Neonatal Hypoglycemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not.
Detailed Description:
Antenatal corticosteroids (ACS) are widely used to enhance fetal lung maturation in pregnancies at risk of preterm birth. However, their role in early-term pregnancies (37 to 38 weeks gestation) prior to planned cesarean section has been gaining attention. Early-term neonates delivered by cesarean section are at an increased risk of respiratory complications, and studies have shown that ACS can reduce these risks by accelerating fetal lung development. The use of ACS in this population, however, has raised concerns about its potential effects on neonatal metabolic outcomes, particularly neonatal hypoglycemia.
Neonatal hypoglycemia, a common metabolic disorder in the early postnatal period, is often associated with antenatal corticosteroid exposure. ACS may increase fetal insulin production by stimulating pancreatic beta cells, leading to an increased risk of hypoglycemia after birth. Research indicates that while ACS effectively reduces respiratory morbidity in early-term neonates, it may concurrently raise the risk of neonatal hypoglycemia. For instance, a meta-analysis found a significant association between ACS and an increased incidence of hypoglycemia in term and near-term infants.
Given these findings, research is crucial to assess the balance of risks and benefits of ACS in early-term cesarean deliveries. While ACS appears to reduce respiratory complications, understanding its full impact on neonatal hypoglycemia will help guide its use in clinical practice
Neonatal hypoglycemia, a common metabolic disorder in the early postnatal period, is often associated with antenatal corticosteroid exposure. ACS may increase fetal insulin production by stimulating pancreatic beta cells, leading to an increased risk of hypoglycemia after birth. Research indicates that while ACS effectively reduces respiratory morbidity in early-term neonates, it may concurrently raise the risk of neonatal hypoglycemia. For instance, a meta-analysis found a significant association between ACS and an increased incidence of hypoglycemia in term and near-term infants.
Given these findings, research is crucial to assess the balance of risks and benefits of ACS in early-term cesarean deliveries. While ACS appears to reduce respiratory complications, understanding its full impact on neonatal hypoglycemia will help guide its use in clinical practice
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: