| CTRI Number |
CTRI/2025/10/096313 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Artificial Intelligence to Protect Mothers by Finding Preeclampsia Early |
|
Scientific Title of Study
|
Visionary AI Pioneering Diagnostic Tools to Improve Early Detection of Preeclampsia Worldwide |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrityunjay Metgud |
| Designation |
Professor of OBGYN |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of OBGYN
1st Floor,
Jawaharlal Nehru Medical College,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
918312444190 |
| Fax |
|
| Email |
metm67@jnmc.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrityunjay Metgud |
| Designation |
Professor of OBGYN |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of OBGYN
1st Floor,
Jawaharlal Nehru Medical College,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
918312444190 |
| Fax |
|
| Email |
metm67@jnmc.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrityunjay Metgud |
| Designation |
Professor of OBGYN |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of OBGYN
1st Floor,
Jawaharlal Nehru Medical College,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
918312444190 |
| Fax |
|
| Email |
metm67@jnmc.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Gates Foundation |
| Address |
500 Fifth Avenue North, Seattle, WA 98109, USA |
| Type of Sponsor |
Other [Research Foundation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mrityunjay Metgud |
Jawaharlal Nehru Medical College |
Department of OBGYN
1st Floor, JNMC Campus
Nehru Nagar
Belgaum
KARNATAKA |
9164693333
metm67@jnmc.edu |
| Dr Ashalata Mallapur |
S. Nijalingappa Medical College and H.S.K Hospital & Research Centre |
Womens and Childrens Health Research Unit, OBG Block, 3rd Floor, SNMC Campus, Navanagar 587103
Bagalkot
KARNATAKA |
9945699986
drashalatamallapur@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of KLE Academy of Higher Education and Research, Belagavi, Karnataka |
Approved |
| SNMC Institutional Ethics Committee on Human Subjects Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, (2) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women between 18 – 40 years of age.
2. Live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat.
3. Intended to deliver within a facility
|
|
| ExclusionCriteria |
| Details |
1. Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.)
2. Inability to obtain any high quality retinal imaging with Optos (i.e., extremely small pupil size, corneal opacities, dense cataracts, vitreous hemorrhage). If one eye is able to be imaged (such as monocular after trauma), this is not viewed as an exclusion. If only Optos wide-field is able to be obtained (such as may happen with small pupil with Remidio), this is not viewed as an exclusion. If a participant is unable to acquire any OPTOS images (better for small pupil than Remidio), she will be deemed ineligible for this study. The number of participants who are not able to be captured by OPTOS is expected to be small, and will be tracked.
3. Unable to provide informed consent, as deemed by site PI |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hypertensive disorders of pregnancy (HDP) and Preeclampsia (PEC) |
Time 1 12 weeks +/- 1 week
Time 2 20 weeks +/-1 week
Time 3 28 0/7 weeks to 32 and 6/7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gestational hypertension |
New onset after 20 weeks without the development of proteinuria |
| Severe preeclampsia |
New onset after 20 weeks without the development of proteinuria |
| Early Onset Preeclampsia |
before 34 weeks GA |
| Gestational diabetes |
Anytime during pregnancy |
Vaginal bleeding and /or Antepartum hemorrhage
|
Anytime during pregnancy |
| Postpartum hemorrhage |
After delivery before 6 weeks postpartum |
| Postpartum hypertension |
After delivery before 6 weeks postpartum |
| Postpartum infection |
After delivery before 6 weeks postpartum |
| Postpartum stroke or heart failure |
After delivery before 6 weeks postpartum |
| Postpartum readmission |
After delivery before 6 weeks postpartum |
| Maternal mortality |
Form conception till 6 weeks partum. |
| Late abortion |
After 20 weeks till 28 weeks GA |
| Change in maternal hemoglobin |
Anytime during pregnancy |
| Transfer to a higher level of care |
Anytime during pregnancy and postpartum till 6 weeks |
| Perinatal mortality |
From 28 weeks GA till 1 weeks post partum |
Birth weight less than 2500g and less than 1500g
|
At delivery |
Fetal loss or Spontaneous abortion
|
At delivery |
| Still birth |
at delivery |
Medical termination of pregnancy
|
At delivery |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [metm67@jnmc.edu].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background and Rationale
Hypertensive disorders of
pregnancy (HDP), including preeclampsia (PEC), are the second leading cause of
maternal deaths worldwide and contribute significantly to preterm birth (PTB),
stillbirth and lifelong maternal health complications, including cardiovascular
disease, stroke, and vascular dementia.
The pre-eclampsia (PEC) and Hypertensive Disorders of
Pregnancies (HDP) and other Adverse Pregnancy Outcomes (APOs) drive maternal
and neonatal mortality, accurate low-cost diagnostic methods that are readily
deployable in LMIC settings early in pregnancy are largely absent. To address
this deficit, our proposal pioneers a high-resolution, non-invasive retinal
imaging approach, combined with artificial intelligence (AI), to predict PEC
and potentially other APOs early in
pregnancy. This approach is grounded in the observation that those at risk
for HDP/PEC exhibit increased vascular reactivity on retinal imaging well
before clinical detection, as placental and maternal vascular changes begin in
the first trimester.1 By
integrating retinal vascular imaging and AI-based feature extraction to
identify early biomarkers of APO risk, we believe we can accurately
discriminate risk as early as the first trimester. |