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CTRI Number  CTRI/2024/12/077771 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessment of markers of Preeclampsia after delivery and correlation with future risk factors of CVD in women 
Scientific Title of Study   Assessment of markers of Preeclampsia after delivery and correlation with future risk factors of Cardio vascular disease in women 
Trial Acronym  CVD  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Garima Kachhawa 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI
ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI
New Delhi
DELHI
110029
India 
Phone  09868246702  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Garima kachhawa 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI
ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI

DELHI
110029
India 
Phone  09868246702  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Garima Kachhawa 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI
ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI
New Delhi
DELHI
110029
India 
Phone  09868246702  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Source of Monetary or Material Support  
ICMR, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  ICMR, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
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 Garima Kachhawa  AIIMS, New Delhi  Room number-701, 7th floor, MCH Block, AIIMS, New Delhi-110029
New Delhi
DELHI 
09868246702

garimakachhawa2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O908||Other complications of the puerperium, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  This is observational trial  This is observational trial 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Women over 18 years of age.
2. Diagnosed with hypertension during pregnancy (preeclampsia and gestational hypertension).
 
 
ExclusionCriteria 
Details  1. History of chronic kidney disease, heart disease, diabetes with renal involvement or vasculopathy.
2. Pregnancy with chronic hypertension, other pre-existing medical conditions or history of illicit drug use.
3. Intervention that could modify the outcome like aspirin use.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life.
2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker
3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women.
4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life.
5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life
 
1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life.
2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker
3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women.
4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life.
5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life
 
 
Secondary Outcome  
Outcome  TimePoints 
1. We expect from this study to see the trend of inflammatory and biochemical markers in post delivery HDP women and to early predict risk factor of CVD later in life.
2. We expect that in this study to find, there is any difference between normalization of raised inflammatory marker and difference in biochemical marker
3. We will also do non invasive test (ETCO levels) and see the correlation with biomarkers. We hope to use these markers as screening tool for triaging women.
4. Most of these markers are assessed during antenatal period and very few studies are done in postpartum period. Of these sFlt1 and hCRP are specifically and strongly associated with development of CVD later in life.
5. Women who had hypertensive disorder in pregnancy with altered inflammatory markers may differentiate women at risk of developing hypertension a precursor of CVD later in life
 
6 WEEK, 6 MONTHS AND 12 MONTHS 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
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)   15/12/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

Hypertensive disorders of pregnancy (HDP) including preeclampsia occur in almost 10% of gestations. These women are known to have higher cardiovascular morbidity and mortality later in life in comparison with parous controls that had normotensive pregnancies. The pathophysiologic mechanisms linking preeclampsia (PE) and gestational hypertension (GH) to maternal CVD later in life are not well understood; however, several hypotheses have been proposed. Studies during pregnancy reported that the newly identified stage 1 hypertension in pregnancy was associated with increased risk of preeclampsia compared with normotensive women (39% versus 15%) (27). The United Nations Sustainable Development Goal (SDG) 3: Good health and Wellbeing aims to ensure healthy lives and promote well-being for all at all ages (3). Studies have shown that women with PE have a 12-fold increase in having a cardiovascular event. A meta-analysis demonstrated a 4.2-fold increased risk of heart failure, a 2.5-fold increased risk of coronary artery disease, and a 1.8-fold increased risk of stroke in women with preeclamptic pregnancies over a follow up period of up to 39 years (25,31). A possibility is that HDP and subsequent CVD share common predisposing risk factors and are both manifestations of the same pathophysiologic processes at different times in a woman’s life.  Pregnant women after delivery go back to society and only come back in contact with health care system once she develops hypertension or any cardiovascular event. Thus a very critical window period is lost where in modification of risk factors or prevention of complications can be as taken. There are various biomarkers which are used to predict severity of preeclampsia during antenatal period however very limited data is available after delivery in these women. Biomarkers and inflammatory markers sFlt, NLR, PLR, hCRP and ETCO is higher associated with the development and severity of preeclampsia so we aim to evaluate correlate noninvasive, inflammatory marker and biomarkers after delivery and correlate at risk of developing hypertension a precursor of CVD later in life.

 
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