FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details  Nil 
 
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.

 
Close