Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia

December 3, 2024 updated by: Andrew Bahgat Heshmat, Assiut University

The Effect of Antenatal Corticosteroids Prior to Planned Cesarean Section in Early Term on Neonatal Hypoglycemia

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Women Health Hospital, Faculty of medicine, Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women Health Hospital, Faculty of medicine, Assiut university

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients took antenatal corticosteroids prior to planned cesarean section
Drug: Corticosteroid Injection
Participants who have received antenatal corticosteroids (betamethasone or dexamethasone) prior to cesarean section as part of their prenatal care.
patients didnt't take antenatal corticosteroids prior to planned cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not..
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antenatal corticosteroids

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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