| 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
|
|
|
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
|
|
|
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 “The 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 |