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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
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Labor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    February 3, 2017
    Last Updated
    February 20, 2019
    Sponsor
    Unity Health Toronto
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    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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