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

• ClinicalTrials.gov Identifier: NCT03057717
• Recruitment Status: Completed
• First Posted: February 20, 2017
• Last Update Posted: February 22, 2019
• Sponsor: St. Michael's Hospital, Toronto
• Information provided by (Responsible Party): St. Michael's Hospital, Toronto

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators

• Principal Investigator: Howard Berger, MD; St. Michael's Hospital, Toronto

More Information

• Responsible Party: St. Michael's Hospital, Toronto
• ClinicalTrials.gov Identifier: NCT03057717
• Other Study ID Numbers: 10-189
• First Posted: February 20, 2017
• Last Update Posted: February 22, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications