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Search / Trial NCT05994443

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Antenatal Corticosteroids Fetal Brain Growth

ClinConnect Summary

The "Fetal Brain Growth - Pilot Study" is a research trial that aims to understand how certain conditions during pregnancy affect the growth of a baby's brain before and after birth. Specifically, the study focuses on pregnant women who are experiencing threatened preterm labor (which means their baby might be born early) and who have received treatment called antenatal corticosteroids, compared to women who do not have these conditions. The researchers will use special types of ultrasound to measure the brain growth of the babies over time.

To participate, women must be between 22 to 34 weeks pregnant and either be experiencing threatened preterm labor and receive corticosteroids or be in a healthy pregnancy without these issues. Participants will need to visit the clinic for extra check-ups, including four visits during pregnancy and one visit after the baby is born. This study is currently looking for volunteers, and it’s important to note that certain health conditions may prevent someone from joining, such as major birth defects or severe health problems in the mother. If you’re interested, this study could provide valuable insights into fetal brain development during challenging pregnancies.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Mcgill University Health Centre/Research Institute Of The Mcgill University Health Centre

The McGill University Health Centre (MUHC) and the Research Institute of the McGill University Health Centre (RI-MUHC) are leading institutions in clinical research and healthcare innovation. With a commitment to advancing medical knowledge and improving patient outcomes, the MUHC integrates cutting-edge research with high-quality patient care. The RI-MUHC fosters a collaborative environment where multidisciplinary teams engage in transformative research across various fields, including oncology, neurology, and cardiovascular health. By leveraging state-of-the-art facilities and a robust network of clinical expertise, both entities strive to translate scientific discoveries into effective treatments, ultimately enhancing the quality of life for patients locally and globally.

Locations

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Anne-Maude Morency, MD

Principal Investigator

RI-MUHC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported