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

NCT ID: NCT03057717

Last Updated: 2023-12-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-20

Study Completion Date

2016-09-01

Brief Summary

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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

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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.

Conditions

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Preterm Labor Fetal Glucocorticoid Exposure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ultrasound

All participants in the study will have fetal thymus size measured using ultrasound.

Group Type OTHER

2D ultrasound assessment

Intervention Type OTHER

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

Interventions

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2D ultrasound assessment

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Berger, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Other Identifiers

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10-189

Identifier Type: -

Identifier Source: org_study_id