Status:
UNKNOWN
Fetal Brain Growth - Pilot Study
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
McGill University
University of Arizona
Conditions:
Preterm Labor
Maternal Psychological Distress
Eligibility:
FEMALE
18+ years
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 (T...
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) sit...
Eligibility Criteria
Inclusion
- Exposed group - TPL and ACS:
- 22-34 weeks and 6 days gestation at time of recruitment.
- Threatened preterm labor (TPTL)
- Administration of a partial or full course of ACS.
- Admission to the MUHC-RVH birthing center or the antenatal floor (D6S).
- Delivery planned at the MUHC-RVH or an institution around the Greater Montreal Area.
- Non-exposed group:
- At or prior to 22 weeks gestation at time of recruitment.
- Delivery planned at the MUHC-RVH.
Exclusion
- Major congenital anomalies, suspected fetal syndrome or genetic disease, or intra-uterine fetal growth restriction.
- Significant maternal disease which may cause preterm delivery or fetal growth restriction (e.g., severe infection, uncontrolled hypertension or diabetes).
- Patients who received more than one course of ACS prior to enrollment.
- Patients on any oral or other systemic corticosteroids, with the exception of inhaled corticosteroids.
- BMI over 35.
Key Trial Info
Start Date :
June 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05994443
Start Date
June 8 2023
End Date
December 1 2025
Last Update
August 16 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
McGill University Health Centre
Montreal, Quebec, Canada