Fetal Brain Growth - Pilot Study

NCT05994443 | Unknown

• 1 other identifier: 2023-8114
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 (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).

Conditions

Preterm Labor; Maternal Psychological Distress

Keywords

Antenatal corticosteroids; fetal brain growth

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Secondary Outcomes (1)

• Prenatal ultrasound measurements

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with singleton pregnancies on our site.

You may qualify if:

• Exposed group - TPL and ACS:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• McGill University: collaborator
• University of Arizona: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anne-Maude Morency, MD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Villegas M., MSc

CONTACT

514-412-4400; daniela.villegas.martinez@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: August 16, 2023
• Study Start: June 8, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)