Improving fetal growth restriction detection
| ISRCTN | ISRCTN10900816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10900816 |
- Submission date
- 06/03/2023
- Registration date
- 15/03/2023
- Last edited
- 17/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
Fetal growth restriction (FGR) refers to babies that are born smaller than the general population. FGR affects 10% of all pregnancies. FGR fetuses are at significantly higher risk of complications, including fetal death and premature birth. FGR deliveries in Malaysia are increasing every year. The current detection technique is not perfect and is reported to miss 50% of FGR before birth. There is thus an urgent need to investigate new technology to improve FGR detection.
Evidence has shown that artificial intelligence (AI) is feasible for disease prediction/prognostication but there is a lack of studies in obstetrics. In this study, the goal is to develop AI technology to improve outcomes with early FGR detection using antenatal measurements and maternal serum biomarkers.
Who can participate?
Pregnant women aged between 18 to 50 years who attend Universiti Malaya Medical Center for pregnancy scanning
What does the study involve?
In Phases 1 and 2, the researchers will extract data from the past 10 years (June 2011 - May 2020). In Phase 3, they will recruit pregnant mothers with a low or high risk of FGR from January to December 2024 and take blood samples.
What are the possible benefits and risks of participating?
There is no expected immediate benefit to the participants. However, the data is expected to generate useful scientific knowledge in the long term. For Phases 1 and 2, no risk will be involved because the researchers are extracting data from a database. In Phase 3, one potential risk is that taking blood may cause discomfort. However, the researchers will only take the blood test after obtaining the patient's consent and any patients who are deemed not fit to take blood tests by the physicians will not be recruited.
Where is the study run from?
Universiti Malaya Medical Center (Malaysia)
When is the study starting and how long is it expected to run for?
May 2021 to June 2025
Who is funding the study?
Ministry of Science, Technology and Innovation (Malaysia)
Who is the main contact?
1. Dr Rahmah bin Saaid, rahmah@ummc.edu.my
2. Dr Saw Shier Nee, sawsn@um.edu.my
Contact information
Principal Investigator
Faculty of Computer Science and Information Technology
Kuala Lumpur
59200
Malaysia
| Phone | +60 (0)3 79676341 |
|---|---|
| sawsn@um.edu.my |
Study information
| Study design | Single-center observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | An AI-driven fetal monitoring model to predict fetal growth restriction infants |
| Study objectives | 1. To enable early identification of fetuses at risk for fetal growth restriction (FGR) via the development and design of a personalized AI-based risk prognostic algorithm based on retrospective data of delivered infants 2. To enhance clinical fetal surveillance and management by differentiating between a true FGR and constitutional small for gestational age (SGA) and hence reduce morbidity risks 3. To evaluate the AI risk prognostic algorithm sensitivity of FGR detection with information from the developed AI using prospective new data and maternal serum biomarkers |
| Ethics approval(s) | Approved 26/08/2021, Medical Research Ethics Committee, University Malaya Medical Centre (2nd floor, Kompleks Pendidikan Sains Kejururawatan, Pusat Perubatan Universiti Malaya 59100 Kuala Lumpur, Malaysia; +60 (0)3 7949 3209 / 2251 / 8473 / 4656; ummc-mrec@ummc.edu.my), ref: 2021329-9997 |
| Health condition(s) or problem(s) studied | Fetal growth restriction, small-for-gestational-age |
| Intervention | In this research, the participants will undergo routine prenatal ultrasound scans throughout the entire pregnancy. This involves approximately five scans in total, which are conducted during the first, second and third trimesters. Besides that, the participants will have a non-invasive blood test during the first ultrasound scan, where 5 ml of blood will collect one time only. Every scan measures the fetus's growth to identify the growth-restricted fetuses earlier and take action to improve the outcomes for the growth-restricted fetus. The total duration of observation is typically from Week 11-14 until Week 36, which is around 6 months. The frequency of scans varies depending on the fetus’s condition, with some participants requiring weekly or bi-weekly scans. |
| Intervention type | Other |
| Primary outcome measure | Maternal information and fetal measurements recorded using ultrasound at first (around 11-14 weeks), second (around 20-22 weeks) and third trimester (around 30-32 weeks) |
| Secondary outcome measures | 1. Maternal demographics recorded from patient files at the first visits 2. Fetal measurements measured using ultrasound over the pregnancy period (11-14 weeks, 20-22 weeks, 30-32 weeks, and 35-36 weeks) 3. Maternal serum biomarkers measured using blood tests during the first trimester |
| Overall study start date | 01/05/2021 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | Inclusion criteria for Phases 1, 2 and 3: 1. Pregnant women with age of between 21 and 50 years 2. Subjects are already scheduled for routine antenatal ultrasound evaluation |
| Key exclusion criteria | Phases 1 and 2: 1. Fetuses with chromosomal and cardiovascular abnormalities and cases with incomplete data Phase 3: 1. Patients who, for any reason, are deemed unfit for blood taking, as determined by their physician 2. Fetus with chromosomal and cardiovascular abnormalities |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
University/education
Federal Territory of Kuala Lumpur
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)379673502 |
|---|---|
| dekan_fsktm@um.edu.my | |
| Website | https://www.um.edu.my/ |
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science, Technology and Innovation, Malaysia, MOSTI
- Location
- Malaysia
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| 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 are/will be available upon request from Dr Rahmah bin Saaid (rahmah@ummc.edu.my) and Dr Saw Shier Nee (sawsn@um.edu.my) subject to approval from the ethics committee. |
Editorial Notes
17/06/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2025 to 31/01/2025.
2. The total final enrolment was added.
18/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/10/2024 to 30/06/2025.
2. The overall study end date was changed from 31/12/2025 to 30/06/2025.
3. The intention to publish date was changed from 31/12/2026 to 30/09/2025.
03/04/2023: Internal review.
07/03/2023: Trial's existence confirmed by the Medical Research Ethics Committee, University Malaya Medical Centre.
