Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia
NCT ID: NCT06716918
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
188 participants
OBSERVATIONAL
2025-01-01
2025-10-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients took antenatal corticosteroids prior to planned cesarean section
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
No interventions assigned to this group
Interventions
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Corticosteroid Injection
Participants who have received antenatal corticosteroids (betamethasone or dexamethasone) prior to cesarean section as part of their prenatal care.
Eligibility Criteria
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Inclusion Criteria
2\. Participants who have received antenatal corticosteroids prior to cesarean section as part of their prenatal care.
Exclusion Criteria
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
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Andrew Bahgat Heshmat
Resident doctor
Locations
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Women Health Hospital, Faculty of medicine, Assiut university
Asyut, , Egypt
Countries
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Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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Antenatal corticosteroids
Identifier Type: -
Identifier Source: org_study_id