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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057717
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, 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.

Condition or disease Intervention/treatment Phase
Preterm Labor Fetal Glucocorticoid Exposure Other: 2D ultrasound assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune
Actual Study Start Date : August 20, 2010
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Fetal Thymus Size [ Time Frame: 24 weeks gestation to delivery ]
    Fetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057717


Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Howard Berger, MD St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03057717    
Other Study ID Numbers: 10-189
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications