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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Labor; Fetal Glucocorticoid Exposure
• Intervention / Treatment: Other: 2D ultrasound assessment

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ultrasound; All participants in the study will have fetal thymus size measured using ultrasound.	Other: 2D ultrasound assessment; 2D ultrasound assessment of fetal thymus size with measurements of the maximum transverse diameter and thymus perimeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Thymus Size	Fetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone	24 weeks gestation to delivery

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Howard Berger, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2010
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature
• Other Study ID Numbers: 10-189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No