Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia

NCT06716918 | Not Yet Recruiting FDA Drug

• 1 other identifier: Antenatal corticosteroids
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antenatal Corticosteroids

Outcome Measures

Primary Outcomes (1)

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

  9 months

Study Arms (2)

patients took antenatal corticosteroids prior to planned cesarean section

Drug: Corticosteroid Injection

patients didnt't take antenatal corticosteroids prior to planned cesarean section

Interventions

Corticosteroid Injection DRUG

Participants who have received antenatal corticosteroids (betamethasone or dexamethasone) prior to cesarean section as part of their prenatal care.

patients took antenatal corticosteroids prior to planned cesarean section

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women Health Hospital, Faculty of medicine, Assiut university

You may qualify if:

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

You may not qualify if:

• \. Women delivering before 37 weeks or after 39 weeks of gestation would be excluded, as the study focuses on early-term deliveries.
• \. 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.
• \. Women with severe maternal health such as preeclampsia, chronic hypertension, or other systemic illnesses, might be excluded to avoid confounding variables.
• \. 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.
• \. 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.
• \. Neonates with known congenital anomalies, genetic disorders, or other pre-existing medical conditions that could affect glucose metabolism

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital, Faculty of medicine, Assiut university

Asyut, Egypt

Location

Related Publications (4)

• Melamed N, Asztalos E, Willan AR, et al. Neonatal hypoglycemia following administration of antenatal corticosteroids: A systematic review and meta-analysis. J Obstet Gynaecol Can. 2017;39(1):36-45.

  BACKGROUND

• Stutchfield PR, Whitaker R, Gliddon AE, Hobson L, Kotecha S, Doull IJ. Behavioural, educational and respiratory outcomes of antenatal betamethasone for term caesarean section (ASTECS trial). Arch Dis Child Fetal Neonatal Ed. 2013 May;98(3):F195-200. doi: 10.1136/archdischild-2012-303157. Epub 2013 Feb 19.

  PMID: 23424017 BACKGROUND

• Kamath-Rayne BD, Rozance PJ, Goldenberg RL, Jobe AH. Antenatal corticosteroids beyond 34 weeks gestation: What do we do now? Am J Obstet Gynecol. 2016 Oct;215(4):423-30. doi: 10.1016/j.ajog.2016.06.023. Epub 2016 Jun 21.

  PMID: 27342043 BACKGROUND

• Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27.

  PMID: 27131581 BACKGROUND

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

andrew bahgat heshmat, resident doctor

CONTACT

01283104773; androbahgat7@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

EG (1)