Study of brain health in women of childbearing age
| ISRCTN | ISRCTN44876504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44876504 |
- Submission date
- 29/03/2025
- Registration date
- 01/04/2025
- Last edited
- 01/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The aim of this project is to investigate the changes in brain cognitive ability and body movement as well as to systematically assess the structural and functional characteristics of the brain in women of childbearing age. By utilizing structural MRI, functional MRI and advanced quantitative imaging techniques (e.g., QSM, DTI, etc.), the brain imaging characteristics of women of childbearing age are depicted. With the help of multimodal data and machine learning methods, an individualized brain health risk assessment model is constructed to provide a basis for early identification of brain function abnormalities. The ultimate goal is to provide scientific and individualized brain health management strategies for women of childbearing age, and to promote the development of the concept of integrating reproductive health and brain health.
Who can participate?
Women of childbearing age between 18 and 49 years.
What does the study involve?
The research includes evaluating how people think and move, testing blood for various substances, and taking images of the brain using structural MRI, functional MRI and advanced quantitative imaging techniques (e.g., QSM, DTI, etc.).
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. However, it can provide scientific and individualized brain health management strategies for women of childbearing age and promote the development of the concept of integrating reproductive health and brain health.
Where is the study run from?
Jinan Maternity And Child Care Hospital Affiliated to Shandong First Medical University (China)
When is the study starting and how long is it expected to run for?
January 2019 to December 2029
Who is funding the study?
Jinan Maternity And Child Care Hospital Affiliated to Shandong First Medical University (China)
Who is the main contact?
wqq179686@163.com
Contact information
Public
No.2,Xiao Jiansan Road,Jinan
Jinan
250001
China
 ORCID ID |
0009-0005-3014-937X |
|---|---|
| Phone | +86 53189029594 |
| wqq179686@163.com |
Scientific
Jing-wu Road No. 324
Jinan
250021
China
| ORCID ID |
0000-0002-4885-625X |
|---|---|
| Phone | +86 531-68776789 |
| glfsci@163.com |
Principal Investigator
No.2,Xiao Jiansan Road,Jinan
Jinan
250001
China
| ORCID ID |
0000-0002-3228-6926 |
|---|---|
| Phone | +86 53189029594 |
| ylf19860928@126.com |
Study information
| Study design | Observational cross sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community, Hospital |
| Study type | Diagnostic, Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Neuroimaging study of changes in brain cognitive-motor function in women of childbearing age |
| Study objectives | This study aims to investigate the trajectory of cognitive function and motor ability in women of reproductive age, and to systematically elucidate how the structural and functional changes in the brain during pregnancy affect the neuropsychiatric state, and to reveal the underlying biological mechanisms. Through this study, we hope to optimize the diagnostic process, improve the accuracy of prognostic assessment, and pinpoint potential therapeutic targets to improve the health of women of childbearing age. |
| Ethics approval(s) |
Approved 18/06/2019, The Medical Ethics Committee of Jinan Maternity And Child Care Hospital Affiliated to Shandong First Medical University (2 Jian-guo Xiao Jing-san Road, Jinan, 250001, China; +86 531 8902 9000; 18254887757@126.com), ref: 20190618 |
| Health condition(s) or problem(s) studied | Changes in cognitive and motor function in women of childbearing age |
| Intervention | After enrollment, participants will undergo assessments of thinking and movement abilities, blood tests for various substances, and brain imaging using quantitative susceptibility mapping (QSM) technology. The total duration of observation is 10 years, from November 1, 2019, to December 1, 2029. Follow-up will start from enrollment, with QSM brain iron measurements taken at baseline, 2 years, and 5 years, with overall follow-up continuing until December 1, 2029. |
| Intervention type | Other |
| Primary outcome measure | Brain iron is measured using Quantitative susceptibility mapping (QSM) at pre-pregnancy, pregnancy and post-partum. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/11/2019 |
| Completion date | 01/12/2029 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 49 Years |
| Sex | Female |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Women of childbearing age between 18 and 49 years 2. Right-handedness |
| Key exclusion criteria | 1. History of brain trauma, surgery, or tumors 2.History of severe cerebrovascular, neurological, or mental diseases 3.Alcohol or drug abuse 4.MRI contraindications |
| Date of first enrolment | 01/12/2019 |
| Date of final enrolment | 01/11/2026 |
Locations
Countries of recruitment
- China
Study participating centre
Jinan
250001
China
Sponsor information
Hospital/treatment centre
No.2,Xiao Jiansan Road
Jinan
250001
China
| Phone | +86 53189029594 |
|---|---|
| wqq179686@163.com |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Linfeng Yang, ylf19860928@126.com |
Editorial Notes
31/03/2025: Trial's existence confirmed by The Medical Ethics Committee of Jinan Maternity And Child Care Hospital Affiliated to Shandong First Medical University.
