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CTRI Number  CTRI/2024/05/067148 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparison of Cord Blood Lipid Profile among Hypertensive and Normotensive Mothers 
Scientific Title of Study   Comparison of Cord Blood Lipid Profile among Hypertensive and Normotensive Mothers: A one year case-control study at KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Sinha 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Floor, Labor Room, Department of Obstetrics and Gynaecology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
5900010
India 
Phone  8689983399  
Fax    
Email  divyasinha207@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shridevi Metgud 
Designation  Assistant Professor, Consultant OBG, Department of Obstetrics and Gynaecolgy 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Floor, Labor Room, Department of Obstetrics and Gynaecology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7353195431  
Fax    
Email  shridevi.metgud@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Divya Sinha 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Floor, Labor Room, Department of Obstetrics and Gynaecology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8689983399  
Fax    
Email  divyasinha207@gmail.com  
 
Source of Monetary or Material Support  
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi 
 
Primary Sponsor  
Name  Divya Sinha 
Address  Jawaharlal Nehru Medical College, Belagavi- 590010, Karnataka, India 
Type of Sponsor  Other [SELF] 
 
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 Divya Sinha  KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC Belagavi  G-1 floor,Labor Room, Department of Obstetrics and Gynaecology, JNMC, Nehru Nagar, Belagavi- 590010
Belgaum
KARNATAKA 
8689983399

divyasinha207@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O141||Severe pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Singleton term pregnancy
2. Group A- women with gestational hypertension, chronic hypertension with superimposed pre-eclampsia, pre-eclampsia, eclampsia
3. Group B- normotensive women
 
 
ExclusionCriteria 
Details  1. Mothers with pre-existing medical conditions such as cardiovascular disorders, diabetes mellitus, collagen vascular diseases, HIV positive on HAART, known familial dyslipidemia, known case of pre-pregnancy hypertension
2. Non-vigorous baby at birth
3. Still Birth
4. Intra-Uterine Demise 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary objective- To estimate the cord blood lipid profiles in hypertensive and normotensive mothers  37 weeks to 42 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective- To assess cord blood lipid profiles in relation to immediate materno-fetal outcomes  37 weeks to 42 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/05/2024 
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="1"
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  

Introduction and Need for the study
 â€œThe Fetal Origin of Adult Disease Hypothesis” first popularised by Dr David Barker, proposes a direct link between prenatal nutrition and late-onset coronary heart disease. It is hypothesized that the events occurring in the early placental and fetal development will have a profound effect on one’s risk for developing future adult diseases. The changes in maternal circulation will eventually be reflected on fetal circulation too. Hypertensive disorders in pregnancy are associated with changes in lipid profile which can be detected with cord blood sampling. There is placental dysfunction in pre-eclampsia leading to maternal endothelial dysfunction. Consequently, there will be oxidative stress, dyslipidemia and inflammation. A deranged fetal lipid profile, due to either genetic constitution or gestational nutrition or intrapartum stress can continue to adulthood. Cord blood dyslipidemia is not only a manifestation of pre-eclampsia and but may also play a role in its pathogenesis. Neonates born to hypertensive mothers (including pre-eclampsia) can be targeted and followed up to their adult life for occurrence of coronary artery diseases and dyslipidemia.
Despite having a role in the pathogenesis of pre-eclampsia, there is a dearth of knowledge regarding the lipid metabolomics of the cord blood. The normal values of cord blood lipids are not available in our population. Hence, measuring the cord blood lipid profile is easy and feasible to detect the lipid levels at birth in newborns of hypertensive and normotensive mothers. Our study could contribute to developing primary prevention in pre-eclampsia by changing the lipid profiles in suspected mothers who are prone to develop pre-eclampsia.
Data Collection Procedure
An informed consent will be taken after screening for eligibility
Total enrolled study participants will be allotted into group A and group B accordingly and matched according to the age, parity, socio-economic status and mode of delivery.
3 mL venous blood sample will be collected from the mother at the time of admission in plain bulb after admission to labor room/ward under aseptic precautions and 5 mL of cord blood will be collected using clamping method from placental side of umbilical vein in plain bulb and sent to biochemistry laboratory for lipid profile analysis.
After centrifugation, the serums obtained will be analysed for lipid profile by enzymatic method colorimetric method (Cobas Pro by Roche).
The values of TC, TG, HDLc, LDLc and VLDLc will be compared of both mother and their baby in both the groups.
The immediate maternal and fetal outcome will also be noted.
Histopathology reports of placenta with membranes will also be collected of cases with deranged cord blood lipid profile



 
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