Observing fetal brain growth in pregnancies with preterm labor and corticosteroids
Fetal Brain Growth: Effects of Antenatal Corticosteroids on Fetal and Neonatal Brain Development - a Pilot Study
This study looks at how well we can measure brain growth in unborn babies who are at risk of being born early and have been given steroids, compared to those who haven't, using special ultrasound techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT05994443 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to assess 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 those not exposed. Patients with singleton pregnancies will undergo repeated ultrasound evaluations every four weeks, with a maximum of five visits, including one postnatal assessment. The study will recruit women over a 24-month period at the McGill University Health Centre, focusing on the ability to successfully measure brain growth in both exposed and non-exposed groups.
Who should consider this trial
Good fit: Ideal candidates include pregnant women between 22-34 weeks gestation experiencing threatened preterm labor and receiving antenatal corticosteroids.
Not a fit: Patients with major congenital anomalies, significant maternal diseases, or those who have received multiple courses of corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effects of preterm labor and corticosteroid exposure on fetal brain development.
How similar studies have performed: While the approach of using ultrasound to measure fetal brain growth is established, this specific combination of conditions and exposures is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montréal, Quebec
- McGill University Health Centre — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Anne-Maude Morency, MD — Ri-Muhc
- Study coordinator: Daniela Villegas M., MSc
- Email: daniela.villegas.martinez@muhc.mcgill.ca
- Phone: 514-412-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.