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Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia

A

Assiut University

Status

Not yet enrolling

Conditions

Antenatal Corticosteroids

Treatments

Drug: Corticosteroid Injection

Study type

Observational

Funder types

Other

Identifiers

NCT06716918
Antenatal corticosteroids

Details and patient eligibility

About

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

Full 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

Enrollment

188 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Women with singleton pregnancies at 37-38 weeks of gestation (early-term) scheduled for planned cesarean sections.
  1. Participants who have received antenatal corticosteroids prior to cesarean section as part of their prenatal care.

Exclusion criteria

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

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

    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 be excluded, 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 to the added complexity of multiple-birth pregnancies and their unique risk.

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

Trial design

188 participants in 2 patient groups

patients took antenatal corticosteroids prior to planned cesarean section
Treatment:
Drug: Corticosteroid Injection
patients didnt't take antenatal corticosteroids prior to planned cesarean section

Trial contacts and locations

1

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Central trial contact

andrew bahgat heshmat, resident doctor

Data sourced from clinicaltrials.gov

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