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

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057717
• Other study ID #: 10-189
• Status: Completed
• Phase: N/A
• Start date: August 20, 2010
• Est. completion date: September 1, 2016

Study information

• Verified date: December 2023
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Glucocorticoid Exposure
• Obstetric Labor, Premature
• Preterm Labor

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Thymus Size	Fetal thymus size for pregnant women given Betamethasone compared to fetal thymus size for pregnant women not given Betamethasone	24 weeks gestation to delivery