| CTRI Number |
CTRI/2025/05/087084 [Registered on: 19/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Lipidome and DNA Methylation for Understanding the Risk of Cardiovascular Disease in Women with Adverse Pregnancy Outcome |
|
Scientific Title of Study
|
Establishment of Facility (Lipidome and DNA Methylation) Particularly for Understanding the Risk of Cardiovascular Disease in A Cohort of Women with Adverse Pregnancy Outcome |
| 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 Sadhana Joshi |
| Designation |
Professor and Head |
| Affiliation |
Interactive Research School for Health Affairs (IRSHA), (BVDU), Pune |
| Address |
Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth (Deemed to be University) (BVDU), Pune Satara Road, Pune
Pune MAHARASHTRA 411043 India |
| Phone |
8007945167 |
| Fax |
|
| Email |
sadhana.joshi@bharatividyapeeth.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sadhana Joshi |
| Designation |
Professor and Head |
| Affiliation |
Interactive Research School for Health Affairs (IRSHA), (BVDU), Pune |
| Address |
Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth (Deemed to be University) (BVDU), Pune Satara Road, Pune
Pune MAHARASHTRA 411043 India |
| Phone |
8007945167 |
| Fax |
|
| Email |
sadhana.joshi@bharatividyapeeth.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Sadhana Joshi |
| Designation |
Professor and Head |
| Affiliation |
Interactive Research School for Health Affairs (IRSHA), (BVDU), Pune |
| Address |
Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth (Deemed to be University) (BVDU), Pune Satara Road, Pune
Pune MAHARASHTRA 411043 India |
| Phone |
8007945167 |
| Fax |
|
| Email |
sadhana.joshi@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology, CGO Complex, Lodhi Road, New-Delhi - 110003 |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology Government of India |
| Address |
Department of Biotechnology Government of India CGO Complex New Delhi 110003 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Palkar |
Bharati Hospital |
Department of ObGY and Pediatrics, Bharati Hospital, Pune Satara Road, Bharati Vidyapeeth Campus, Dhankawadi Pune MAHARASHTRA |
9881008717
sonali.palkar@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BVDU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Follow up of women post pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Female |
| Details |
Females who had preeclampsia during pregnancy will be followed up post pregnancy. Equal number of females who were normotensive during pregnancy will also be followed up. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lipidome patterns (from maternal plasma and placentae) and DNA methylation patterns of genes involved in lipid metabolism in placentae of women with preeclampsia. |
At delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of lipidome patterns during pregnancy and in later age (approx. 10-16 years post-delivery) and its association with cardiometabolic risk in women at later age |
10-16 years post pregnancy |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
10/06/2025 |
| 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="5" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cardiovascular disease (CVD) is the leading cause of mortality for women in India. Women with a history of adverse pregnancy outcome are suggested to be at a greater risk of developing CVD. In view of this, it is essential to understand the role of prenatal factors which contribute to the increased CVD risk in women in later life. The role of lipids in influencing CVD risk is well established. However, the role of lipid metabolism in the placenta during pregnancy and its influence on the women’s health remains undetermined. Extensive studies at IRSHA on a cohort of women with preeclampsia has highlighted the role of lipids especially fatty acids in influencing pregnancy outcomes. A follow up of this cohort (approx. 15 years post pregnancy) will help us to understand whether changes in prenatal factors during pregnancy can impact or influence the risk of cardiovascular diseases (CVD) in mothers with preeclampsia. The current study for the first time aims to explore the maternal and placental lipidome profile of women with preeclampsia and examine its association with cardiovascular risk factors in later life. The study also aims to understand the underlying molecular mechanisms by examining the DNA methylation of genes involved in lipid metabolism. |