The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune Programming
Primary Purpose
Preterm Labor, Fetal Glucocorticoid Exposure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2D ultrasound assessment
Sponsored by
About this trial
This is an interventional other trial for Preterm Labor
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ultrasound
Arm Description
All participants in the study will have fetal thymus size measured using ultrasound.
Outcomes
Primary Outcome Measures
Fetal Thymus Size
Fetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone
Secondary Outcome Measures
Full Information
NCT ID
NCT03057717
First Posted
February 3, 2017
Last Updated
February 20, 2019
Sponsor
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03057717
Brief Title
The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune Programming
Official Title
The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2010 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor, Fetal Glucocorticoid Exposure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Other
Arm Description
All participants in the study will have fetal thymus size measured using ultrasound.
Intervention Type
Other
Intervention Name(s)
2D ultrasound assessment
Intervention Description
2D ultrasound assessment of fetal thymus size with measurements of the maximum transverse diameter and thymus perimeter
Primary Outcome Measure Information:
Title
Fetal Thymus Size
Description
Fetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone
Time Frame
24 weeks gestation to delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Berger, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune Programming
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