Preterm LaborNCT05994443
Fetal Brain Growth - Pilot Study
An observational study of Preterm Labor and Maternal Psychological Distress, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, Maternal Psychological Distress
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2023to 1 Aug 2026
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with singleton pregnancies on our site.
Who may be able to join
- 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.
Show all 9Show fewer
- Non-exposed group:
- At or prior to 22 weeks gestation at time of recruitment.
- Delivery planned at the MUHC-RVH.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Brain Growth: Effects of Antenatal Corticosteroids on Fetal and Neonatal Brain Development - a Pilot Study
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).
Read the 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.
- Conditions
- Preterm Labor, Maternal Psychological Distress
- Keywords
- Antenatal corticosteroids, fetal brain growth
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women exposed to threatened preterm labor and exposed to antenatal corticosteroids | Pregnant women with threatened preterm labor (TPTL) who received antenatal corticosteroids (ACS) between 22 and 34 weeks and 6 days of gestation at our hospital. | |
| Non-exposed pregnant women | Pregnant women with normal pregnancies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - It is this a feasible project?
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 (in cm) 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 (in cm).
Measured: 2 years
Secondary outcomes (1)
Prenatal ultrasound measurements
Our secondary outcomes will include 2D and 3D ultrasound measurements (in cm) 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start8 Jun 2023
- Primary completion1 Dec 2025
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, University of Arizona
- Responsible party
- Principal investigator, Jarred Garfinkle, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Anne-Maude Morency, MD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994443
- Sponsor's protocol ID
- 2023-8114
- Status last verified
- Aug 2026
- First submitted
- 23 May 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept between collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Brain Growth: Effects of Antenatal Corticosteroids on Fetal and Neonatal Brain Development - a Pilot Study
- ClinicalTrials.gov ID
- NCT05994443
- Acronym / sponsor ID
- 2023-8114
- Conditions
- Preterm Labor, Maternal Psychological Distress
- Keywords
- Antenatal corticosteroids, fetal brain growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- McGill University, University of Arizona
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women exposed to threatened preterm labor and exposed to antenatal corticosteroids | – | –Pregnant women with threatened preterm labor (TPTL) who received antenatal corticosteroids (ACS) between 22 and 34 weeks and 6 days of gestation at our hospital. |
| Non-exposed pregnant women | – | –Pregnant women with normal pregnancies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with singleton pregnancies on our site.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility - It is this a feasible project?
Time frame: 2 years
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 (in cm) 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 (in cm).
1 secondary outcome
Prenatal ultrasound measurements
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Data will be kept between collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Maude Morency, MD principal investigator
RI-MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Maternal Psychological Distress, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - It is this a feasible project? (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.