Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia

Last updated: December 3, 2024
Sponsor: Assiut University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Hormone Deficiencies

Treatment

Corticosteroid Injection

Clinical Study ID

NCT06716918
Antenatal corticosteroids
  • Female

Study Summary

Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women with singleton pregnancies at 37-38 weeks of gestation (early-term)scheduled for planned cesarean sections.

  2. Participants who have received antenatal corticosteroids prior to cesarean sectionas part of their prenatal care.

Exclusion

Exclusion Criteria:

  1. Women delivering before 37 weeks or after 39 weeks of gestation would beexcluded, as the study focuses on early-term deliveries.

  2. Women with any form of diabetes, including pre-existing type 1 or type 2diabetes, and gestational diabetes. This ensures that the study focuses onnon-diabetic populations, as diabetes can independently affect neonatal glucoseregulation and complicate the assessment of hypoglycemia risk due tocorticosteroids.

  3. Women with severe maternal health such as preeclampsia, chronic hypertension,or other systemic illnesses, might be excluded to avoid confounding variables.

  4. Women who did not complete the full course of antenatal corticosteroids may beexcluded, as the effect of partial doses could differ from complete treatment.

  5. Women with multiple gestations (e.g., twins or triplets) may be excluded due tothe added complexity of multiple-birth pregnancies and their unique risk.

  6. Neonates with known congenital anomalies, genetic disorders, or otherpre-existing medical conditions that could affect glucose metabolism

Study Design

Total Participants: 188
Treatment Group(s): 1
Primary Treatment: Corticosteroid Injection
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
October 30, 2025

Study 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

Connect with a study center

  • Women Health Hospital, Faculty of medicine, Assiut university

    Assiut,
    Egypt

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.