Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05994443
Status:
RECRUITING
Last Update Posted:
2023-08-16
First Post:
2023-05-23
Brief Title:
Fetal Brain Growth - Pilot Study
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Fetal Brain Growth Effects of Antenatal Corticosteroids on Fetal and Neonatal Brain Development - a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational prospective study is to explore the feasibility of measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to threatened preterm labor TPTL and antenatal corticosteroids ACS compared to non-exposed fetuses
Patients with singleton pregnancies on our site with repeated ultrasound measurements every 4 weeks will be evaluated for fetal brain development The exposed group is defined as patients with a dual exposure of TPTL and ACS The non-exposed group will be composed of patients who did not have TPTL and ACS Therefore patients will have a maximum of 5 additional visits 4 that will occur prenatally and 1 postnatal visit
Patients with singleton pregnancies on our site with repeated ultrasound measurements every 4 weeks will be evaluated for fetal brain development The exposed group is defined as patients with a dual exposure of TPTL and ACS The non-exposed group will be composed of patients who did not have TPTL and ACS Therefore patients will have a maximum of 5 additional visits 4 that will occur prenatally and 1 postnatal visit
Detailed Description:
The investigators propose a monocentric prospective pilot cohort study of patients with singleton pregnancies admitted to the McGill University Health Centre MUHC - Royal Victoria Hospital RVH site with repeated ultrasound measurements every 4 weeks to evaluate fetal brain development The exposed group is defined as patients with a dual exposure of TPTL and ACS The non-exposed group will be composed of patients who did not have TPTL and ACS Therefore patients will have a maximum of 5 additional visits 4 that will occur prenatally and 1 postnatal visit The investigators plan to recruit women over a period of 24 months and will need an additional period of 6 months to complete data extraction from delivery and perform all postnatal measures
Primary Outcome Our primary outcome will be the feasibility of a prospective observational study measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to TPTL and ACS to non-exposed fetuses Feasibility will be defined on the following criteria 1 Number of patients recruited per month 2 Ability to recruit eligible patients and 3 Ability to successfully complete the 2D measures and 3D volumes for each ultrasound exam Success will be defined by the following criteria 1 At least two patients will be recruited per month 2 At least 50 of all eligible patients exposed to TPTL and ACS will be recruited 3 At least 50 of all 2D measures and 3D volumes could be obtained
Secondary Outcomes Our secondary outcomes will include 2D and 3D ultrasound measurements of fetal brain structures more specifically biparietal diameter head circumference corpus callosum length corpus callosum-fastigium length ventricular width total fetal brain volume frontal lobe volume cerebellar volume and thalamic volume all measurements in cm Neonatal brain structures will also be measured by 2D ultrasound including corpus callosum length and corpus callosum-fastigium length in cm
Exposed patients will have a fetal ultrasound performed by a trained and qualified ultrasound technologist or a Maternal-Fetal Medicine specialist within 4 days of their admission to the hospital Psychometric questionnaires will be filled on the same day Ultrasounds will subsequently be performed at fixed gestational age 24 28 32 and 36 weeks - 4 days
Non-exposed patients will have fetal ultrasound performed by a trained and qualified ultrasound technologist or a Maternal-Fetal Medicine specialist at 24 28 32 and 36 weeks - 4 days Psychometric questionnaires will be filled on each of those days
Primary Outcome Our primary outcome will be the feasibility of a prospective observational study measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to TPTL and ACS to non-exposed fetuses Feasibility will be defined on the following criteria 1 Number of patients recruited per month 2 Ability to recruit eligible patients and 3 Ability to successfully complete the 2D measures and 3D volumes for each ultrasound exam Success will be defined by the following criteria 1 At least two patients will be recruited per month 2 At least 50 of all eligible patients exposed to TPTL and ACS will be recruited 3 At least 50 of all 2D measures and 3D volumes could be obtained
Secondary Outcomes Our secondary outcomes will include 2D and 3D ultrasound measurements of fetal brain structures more specifically biparietal diameter head circumference corpus callosum length corpus callosum-fastigium length ventricular width total fetal brain volume frontal lobe volume cerebellar volume and thalamic volume all measurements in cm Neonatal brain structures will also be measured by 2D ultrasound including corpus callosum length and corpus callosum-fastigium length in cm
Exposed patients will have a fetal ultrasound performed by a trained and qualified ultrasound technologist or a Maternal-Fetal Medicine specialist within 4 days of their admission to the hospital Psychometric questionnaires will be filled on the same day Ultrasounds will subsequently be performed at fixed gestational age 24 28 32 and 36 weeks - 4 days
Non-exposed patients will have fetal ultrasound performed by a trained and qualified ultrasound technologist or a Maternal-Fetal Medicine specialist at 24 28 32 and 36 weeks - 4 days Psychometric questionnaires will be filled on each of those days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None