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The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune Programming

The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03057717
Enrollment
86
Registered
2017-02-20
Start date
2010-08-20
Completion date
2016-09-01
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Glucocorticoid Exposure, Preterm Labor

Brief summary

Administration of corticosteroids is standard practice for pregnant patients at risk of preterm labour to reduce the risk of neonatal respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis and neonatal mortality. However, there is an unknown effect of antenatal steroids on both fetal and neonatal immune function. The purpose of this study is to demonstrate the effect of antenatal steroids on the size of the fetal thymus gland.

Detailed description

Women with a singleton pregnancy in the twenty-forth to thirty-fourth week of gestation who are at risk for preterm labour, requiring the administration of Betamethasone twelve milligrams intramuscularly every twenty-four hours for two doses will be included in this study along with an equal number of gestational-age matched controls not at risk for preterm delivery and therefore not requiring the administration of Betamethasone. A 2-D ultrasound assessment of the fetal thymus size with measurements of the maximum transverse diameter and thymus perimeter in the three-vessel view will be performed as a baseline measurement within 36 hours of the administration of the first dose of corticosteroids. For each patient enrolled, a gestational-age matched control will have a similar ultrasound assessment. These measurements will be repeated 2 weeks after the first baseline ultrasound, and then only patients who received corticosteroids will have subsequent ultrasound measurements every 2 weeks until delivery.

Interventions

OTHER2D ultrasound assessment

2D ultrasound assessment of fetal thymus size with measurements of the maximum transverse diameter and thymus perimeter

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Women with a singleton pregnancy in the twenty-forth to thirty-fourth week of gestation who are at risk for preterm labour, requiring the administration of Betamethasone twelve milligrams intramuscularly every twenty-four hours for two doses will be included in this study along with an equal number of gestational-age matched controls not at risk for preterm delivery and therefore not requiring the administration of Betamethasone.

Exclusion criteria

* chronic use of steroids during pregnancy for other indications * delivery less than 1 week from enrollment * confirmed chorioamnionitis or preterm premature rupture of membranes.

Design outcomes

Primary

MeasureTime frameDescription
Fetal Thymus Size24 weeks gestation to deliveryFetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026