Fetal Brain Growth - Pilot Study (NCT05994443) | Clinical Trial Compass
UnknownNot Applicable
Fetal Brain Growth - Pilot Study
Canada120 participantsStarted 2023-06-08
Plain-language 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).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility - It is this a feasible project?
Timeframe: 2 years
Trial details
NCT IDNCT05994443
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre