Antenatal CorticosteroidsNCT06716918
Effect of Antenatal Corticosteroids on Neonatal Hypoglycemia
An observational study of Antenatal Corticosteroids, run by Assiut University at 1 site in Egypt.
Trial summary
Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Antenatal Corticosteroids
- What is being tested?
- Corticosteroid Injection
- Type of treatment
- Injection or infusion
- How many people
- 188 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2025to 30 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: Women Health Hospital, Faculty of medicine, Assiut university
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Antenatal Corticosteroids
- Being tested
- Corticosteroid Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid InjectionDrug
Participants who have received antenatal corticosteroids (betamethasone or dexamethasone) prior to cesarean section as part of their prenatal care.
| Study group | Role | What they receive |
|---|---|---|
| patients took antenatal corticosteroids prior to planned cesarean section | Not described Receives: Drug: Corticosteroid Injection | |
| patients didnt't take antenatal corticosteroids prior to planned cesarean section | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not..
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start14 Jan 2025
- Primary completion10 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Antenatal CorticosteroidsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Bahgat Heshmat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716918
- Sponsor's protocol ID
- Antenatal corticosteroids
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 23424017Kamath-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.
PubMed 27342043Magro-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.
PubMed 27131581
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antenatal Corticosteroids Prior to Planned Cesarean Section in Early Term on Neonatal Hypoglycemia
- ClinicalTrials.gov ID
- NCT06716918
- Acronym / sponsor ID
- Antenatal corticosteroids
- Conditions
- Antenatal Corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients took antenatal corticosteroids prior to planned cesarean section | – | Drug: Corticosteroid Injection |
| patients didnt't take antenatal corticosteroids prior to planned cesarean section | – | – |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Women Health Hospital, Faculty of medicine, Assiut university
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid InjectionParticipants who have received antenatal corticosteroids (betamethasone or dexamethasone) prior to cesarean section as part of their prenatal care. | Drug | patients took antenatal corticosteroids prior to planned cesarean section |
Primary outcome
Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not..
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Results publicationMelamed 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.
- Results publication: PubMed 23424017Stutchfield 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.
- Results publication: PubMed 27342043Kamath-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.
- Results publication: PubMed 27131581Magro-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.
Related trials for Antenatal Corticosteroids
Active, not recruitingPhase 2
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RecruitingPhase 4
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Recruiting
Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS
Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome, Acute
RecruitingObservational study
Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antenatal Corticosteroids, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the incidence of neonatal hypoglycemia in infants born to mothers who received antenatal corticosteroids to those who did not.. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06716918, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.