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

Not Applicable

Completed

• Conditions: Preterm Labor; Fetal Glucocorticoid Exposure
• Interventions: Other: 2D ultrasound assessment

• Registration Number: NCT03057717
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study Start: 2010-08-20
• Primary Completion: 2016-09-01
• Study Completion: 2016-09-01
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound	2D ultrasound assessment	All participants in the study will have fetal thymus size measured using ultrasound.

Primary Outcome Measures

Name	Time	Method
Fetal Thymus Size	24 weeks gestation to delivery	Fetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone