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CTRI Number  CTRI/2024/03/064329 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To understand whether prediction of preeclampsia can be improved by adding study of maternal heart parameters  
Scientific Title of Study   Role of maternal cardiovascular markers in predicting adverse outcomes in women with Pre eclampsia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Aparna Sharma 
Designation  Professor  
Affiliation  AIIMS New Delhi  
Address  711, 7th floor, Mother and Child block, AIIMS New Delhi

New Delhi
DELHI
110049
India 
Phone  9711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Aparna Sharma 
Designation  Professor  
Affiliation  AIIMS New Delhi  
Address  711, 7th floor, Mother and Child block, AIIMS New Delhi


DELHI
110049
India 
Phone  9711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Niharika Kumari 
Designation  Junior Resident  
Affiliation  AIIMS New Delhi  
Address  49, Hostel 9, Parvati hostel, Ansari Nagar East, AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  7004054498  
Fax    
Email  k.niharika297@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi  
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS New Delhi  
Type of Sponsor  Research institution and hospital 
 
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 Niharika Kumari   AIIMS New Delhi  Room no 105, Fetal Medicine Division, Obstetrics and Gynaecology Department
New Delhi
DELHI 		 7004054498

k.niharika297@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O14||Pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Pregnant women admitted with diagnosis of PE at gestational age lesser than or equal to 34 weeks according to ISSHP criteria
2. Willing to be part pf study 
 
ExclusionCriteria 
Details  1. Presence of fetal chromosomal or structural abnormality
2. Maternal cardiac disease
3. Hematological disorders
4. Multifetal gestation
5. Pre existing chronic hyertension 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Maternal core outcomes
A) Clinical parameters
1. Maternal mortality
2. Eclampsia
3. Stroke
4. Cortical blindness
5. Retinal detachment
6. Pulmonary edema
7. Acute kidney injury
8. Liver capsule hematoma or rupture
9. Placental abruption
10. Post partum haemorrhage
11. Admission to Intensive care unit requiring intubation or mechanical ventilation (not for childbirth)

Perinatal outcomes
1. Stillbirth
2. Gestational age at delivery
3. Birthweight
4. Small for gestational age
5. Neonatal mortality
6. Neonatal seizures
7. Admission to Neonatal unit required
8. Respiratory support required
 		 Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Predictive ability of FullPIERS model for adverse maternal and perinatal outcomes in women with Pre eclampsia
2. Predictive ability of sFLT/PlGF ratio with or without uterine artery doppler for adverse maternal and perinatal outcomes in women with Pre eclampsia
3. Development of a multiparametric model integrating clinical, biochemical, placental and maternal cardiovascular markers for predicting adverse outcomes in women with Pre eclampsia  		 Following initial assessment, patient will be followed up and managed according to institution protocol till 7 days postpartum  
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   26/03/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kaparnasharma@gmail.com].

  6. For how long will this data be available start date provided 29-07-2026 and end date provided 23-07-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to find out role of maternal cardiovascular markers in predicting Preeclampsia and hence to develop a multiparametric model using clinical, biochemical, placental, maternal cardiovascular markers in predicting preeclampsia early. 
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