| 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
|
|
|
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
|
|
|
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. |