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CTRI Number  CTRI/2024/03/064384 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 09/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Cluster Randomized Trial 
Public Title of Study   Developing a protocol for managing pregnant women with heart disease in India, and evaluating the efficacy of the new protocol in improving pregnancy outcome compared to standard care.  
Scientific Title of Study   DevelopmeNt, implementation and evaluation of Protocolized cArdio-obstetric Care in improving maternal cardiac, obstetric and fetal outcomes of Pregnant Women with Heart Diseases in India 
Trial Acronym  NPAC India Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Justin Paul  
Designation  Professor of Cardiology  
Affiliation  Madras Medical College  
Address  Second floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai

Chennai
TAMIL NADU
600003
India 
Phone  9840071558  
Fax    
Email  drjpheart@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Justin Paul  
Designation  Professor of Cardiology  
Affiliation  Madras Medical College  
Address  Second floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai

Chennai
TAMIL NADU
600003
India 
Phone  9840071558  
Fax    
Email  drjpheart@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G Justin Paul  
Designation  Professor of Cardiology  
Affiliation  Madras Medical College  
Address  Second floor, Institute of Cardiology, Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai

Chennai
TAMIL NADU
600003
India 
Phone  9840071558  
Fax    
Email  drjpheart@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 55  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anish Keepanasseril  Jawaharlal Institute of Postgraduate Medical Education & Research   Department of Gynaecology, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY 		 8903307141

keepan_r@yahoo.com 
Dr Surender Deora  All India Institute of Medical Sciences , Jodhpur  Room no:45, OPD BLOCK, 4TH FLOOR, C-BLOCK, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 8003996715

deoras@aiimsjodhpur.edu.in 
Dr Bhupinder Singh  All India Institute of Medical Sciences, Bathinda  Room no: 1013, Department of Cardiology, Mandi Dabwali Rd, Bathinda, Punjab 151001
Bathinda
PUNJAB 		 8427821837

docbhupi@gmail.com 
Dr Shwetha Singh  All India Institute of Medical Sciences, Bhubaneswar  Room No: 409, Department of Obstetrics and Gynaecology, Academic block, Sijua, Patrapada, Bhubaneswar, Odisha 751019
Khordha
ORISSA 		 9438884131

obgyn_sweta@aiimsbhubaneswar.edu.in 
Dr K Aparna Sharma  All India Institute of Medical Sciences, Delhi  Room 714, Mother and Child Block, Ansari Nagar, New Delhi 110608
South West
DELHI 		 9711824415

kaparnasharma@gmail.com 
Dr Arijit Kumar Ghosh  All India Institute of Medical Sciences, Nagpur  Room No: 140, OPD Block, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA 		 8007658278

akumarg@aiimsnagpur.edu.in 
Dr Adil Ahmad Khan  All India Institute of Medical Sciences, Patna  Department of Cardiology, Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bari Khagaul, Bihar 801507
Patna
BIHAR 		 9808688641

adil.amu@gmail.com 
Dr Sarita agrawal  All India Institute of Medical Sciences, Raipur  Room no. 3117, Medical College building, Gate No 5, Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 		 8518881744

drsaritaagrawal@aiimsraipur.edu.in 
Dr Barun Kumar   All India Institute of Medical Sciences, Rishikesh  Room No: 016427, Level 6, Block A, Medical College Building, Shivaji Nagar, Rishikesh, Uttarakhand 249203
Dehradun
UTTARANCHAL 		 8475000331

drbarun79@gmail.com 
Dr Betsy Thomas  Amala Institute of Medical Sciences  Room no: 1, Amala Institute of Medical Sciences Amalanagar, Thrissur, Kerala 680555
Thrissur
KERALA 		 9895579077

betsythomas53@gmail.com 
Dr Navaneetha Sasikumar  Amrita Institute of Medical Sciences  Dept of Pediatric Cardiology, Room No: 3, 5th Floor, Tower 1 , Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
Ernakulam
KERALA 		 9706048664

drnavni@yahoo.com 
Dr I Vani  Andhra Medical College  Administrative block, Room no: 2, Medical College Road King George Hospital, opp. Collector Office, Maharani Peta, Visakhapatnam, Andhra Pradesh 530002
Visakhapatnam
ANDHRA PRADESH 		 9346627652

ivani_20@yahoo.com 
Dr Brig Navreet Singh   Armed Forces Medical College  Dept of Cardiology, Army institute of Cardiothoracic Sciences,Golibar Maiden, Pune-411040
Pune
MAHARASHTRA 		 7087031089

navreet6626@gmail.com 
Dr Umesh Kumar Pandey  Banaras Hindu University, Varanasi  Room no 19, department of cardiology Sir sundar lal hospital, Institute of medical sciences, banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH 		 9784757032

umeshpandey@bhu.ac.in 
Dr C Savitha  Bangalore Medical College and Research Institute  Room Number 1, Department of Obstetrics and Gynaecology, Vanivilas Hospital, Krishna Rajendra Rd, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 		 9844089168

savithakushu@gmail.com 
Dr Dipankar Ghosh Dastidar  Burdwan Medical College and Hospital  Department of Cardiology,Baburbag, P.O.Rajbati, Purba Bardhaman - 713104 West Bengal
Barddhaman
WEST BENGAL 		 9831121347

drdgdastidar@yahoo.co.in 
Dr Bendangtoshi jamir  Christian institute of health sciences and research  Room no: 2, Gynaecology OPD, P.B No 31, 4th Mile, P.O, ARTC, Dimapur, Nagaland 797115
Dimapur
NAGALAND 		 8974848075

jamirbendangdr@gmail.com 
Dr Gurbhej Singh  Christian Medical College  Room No:3125, Department of Cardiology, Brown Rd, CMC Campus, Ludhiana, Punjab 141008
Ludhiana
PUNJAB 		 9567601557

gurbhej.singh@cmcludhiana.in 
Dr Sowmya Sathyendra  Christian Medical College  Room 204, Department of Medicine-Unit 3 and Obstetric medicine, Christian Medical College, IDA Scudder Road, Vellore, Tamil Nadu 632004
Vellore
TAMIL NADU 		 9894449315

sowmya@cmcvellore.ac.in 
Dr R Manonmani   Coimbatore medical college  Room no: 69, Department of OG , Avinashi Rd, Peelamedu, Civil Aerodrome Post, Coimbatore, Tamil Nadu 641018
Coimbatore
TAMIL NADU 		 9344620745

mano.bala789@gmail.com 
Dr Gurpreet Singh Wander  Dayanand Medical College & Hospital  Department of Cardiology,Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001
Ludhiana
PUNJAB 		 9815545316

drgswander@yahoo.com 
Dr Puneet Rastogi  Gajra Raja Medical College  Room No: 1, near to HOD office, Department of Cardiology, Veer Savarkar Marg, Gwalior – 474009
Gwalior
MADHYA PRADESH 		 9827016996

drpuneet_rastogi@yahoo.com 
Dr Praveen Shukla  Ganesh Shankar Vidyarthi Memorial Medical College  Room no:7. 3rd floor old building LPS Institute of Cardiology, Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH 		 8826872722

drpshukla83@gmail.com 
Dr Panchanan Das   Gauhati Medical College  Department of Obstetrics and Gynaecology, Narakasur Hilltop, Bhangagarh, Guwahati, Assam 781032
Kamrup
ASSAM 		 9764063488

panchanan_reeti@yahoo.in 
Dr Michelle Viegas Parab  Goa Medical College  Department of Cardiology, Cardiology office 8th floor, superspeciality block, Bambolim, Goa 403202
North Goa
GOA 		 9923856560

michelleviegas2009@gmail.com 
Dr Jyoti Ramesh Chandran  Government Medical College  Room no: 20, Institute of Maternal and Child health, Kozhikode, Kerala 673008
Kozhikode
KERALA 		 9995353512

chandrandrjyoti9@gmail.com 
Dr Srikanth Nathani  Guntur Medical College  Department of Cardiology, Podila Prasad building second floor, Kanna Vari Thota, Guntur, Andhra Pradesh 522004
Guntur
ANDHRA PRADESH 		 9492662370

nathani_7904@yahoo.co.in 
Dr Sudha TR   Hassan Institute of Medical Sciences  Room No:28,Department of Gynaecology, Sri Chamarajendra Hospital Campus, Krishnaraja Pura, Hassan, Karnataka 573201
Hassan
KARNATAKA 		 9481308902

sudha.tr2009@gmail.com 
Dr Goutam Datta  Institute of Post Graduate Medical Education & Research and SSKM Hospital, Kolkata  Room attached to the office of Prof. Dr. S.C Mandal. Cardiology department, cardiac division, No: 244, A.J.C. Bose Road, Kolkata 700 020
Kolkata
WEST BENGAL 		 8697873048

goutamdattadn@yahoo.in 
Dr Deepika Dewani  Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha  Department of Obstetrics and Gynaecology, Sawangi (Meghe, Wardha, Maharashtra 442005
Wardha
MAHARASHTRA 		 8329576905

deepika.d3@gmail.com 
Dr Rishi Sethi  King Georges Medical University  Research Cell, Room no.11, 1 st floor, Administrative block, Department of Cardiology, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 9838571770

drrishisethi1@gmail.com 
Dr G Justin Paul   Madras Medical College  Room No 1, Firstfloor, Institute of Cardiology, Poonamallee High Rd, Park Town, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU 		 9840071558

drjpheart@gmail.com 
Dr M Gayathiri  Madurai Medical College  Room no: 3, 6th Floor, OG Office, Seema Building, Panagal Road, Alwarpuram, Madurai, Tamil Nadu 625020
Madurai
TAMIL NADU 		 88254 55096

drgayathirim@gmail.com 
Dr Chabbi Satapathy  Maharaja Krushna Chandra Gajapati Medical College  Department of Cardiology Room no 307 2 nd floor PMSSY building MKCG medical College Berhampur
Ganjam
ORISSA 		 9861014660

drsatpathy_2@rediffmail.com 
Dr Sumitra Yadav  Mahatma Gandhi Memorial Medical College  Department of OBG, Room no 9. MTH womens Hospital, MGM Medical College, Mahatma Gandhi Rd, Siyaganj, Indore, Madhya Pradesh 452007
Indore
MADHYA PRADESH 		 9425032348

drsumitrayadav@yahoo.co.in 
Dr Girish M P  Maulana Azad Medical College (MAMC)  Room no: 125, Academic Block, 1st floor, 1, Jawahar lal nehru road, New Delhi, Delhi, 110002
Central
DELHI 		 9891117573

girishpalleda@gmail.com 
Dr Nita Ray  Medical College Kolkata  Department of Obstetrics and Gynaecology, Eden Hospital, ground floor, HOD Room, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL 		 9830171785

kol.nita@gmail.com 
Dr Manish kapoor   North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences  Department of Cardiology, Mawdiangdiang, Shillong, Meghalaya 793018
East Khasi Hills
MEGHALAYA 		 9436335568

drkapoorm@yahoo.co.in 
Dr Krishna mala konda reddy parvathareddy   Osmania Medical College  Department of Cardiology, 1st floor, Turrebaz Khan Rd, Troop Bazaar, Koti, Hyderabad, Telangana 500095
Hyderabad
TELANGANA 		 9848015098

drkmkreddyp@yahoo.com 
Dr Pushpa Dahiya  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science  Department of Obstetrics and Gynaecology, Medical Rd, Rohtak, Haryana 124001
Rohtak
HARYANA 		 9416291029

pushpadahiya@yahoo.com 
Dr Smit Shrivastava  Pt. Jawahar Lal Nehru Memorial Medical College  Department of Cardiology, Advanced Cardiac Institute, Jail Rd, Moudhapara, Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH 		 9425560077

dr.smit.shrivastava@gmail.com 
Dr Archana Kumari  Rajendra Institute of Medical Sciences (RIMS), Ranchi  Department of Obstetrics and Gynaecology, 4th floor, Rajendra Institute of Medical Sciences Bariatu, Ranchi - 834009, Jharkhand
Ranchi
JHARKHAND 		 9471521226

dr_karchana@yahoo.co.in 
Dr Mukesh Kumar Sharma  RN Tagore Medical College  Department iof CARDIOLOGY, Room no: 2, HZL Cardiology centre, Court Chowk, Citys Prime Healthcare Area, Udaipur, Rajasthan 313001
Udaipur
RAJASTHAN 		 9413695861

drmukeshkrsharma@gmail.com 
Dr Satyendra Tewari  Sanjay Gandhi Postgraduate Institute of Medical Sciences  C- block, Department of Cardiology, SGPGIMS, Rae Bareilly Road, Lucknow 226014
Lucknow
UTTAR PRADESH 		 9415012127

stewari_sgpgi@yahoo.com 
Dr Dinesh Choudhary  Sardar Patel Medical College   A Block, Department of Cardiology, HRMC S P Medical College Bikaner 334001
Lucknow
UTTAR PRADESH 		 9414222727

drdineshchoudhary8@gmail.com 
Dr Chandran Bhan Meena  Sawai Man Singh Medical College  Room No:208, Department of Cardiology, New Sms Campus Rd, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN 		 8619445328

drcbhan@gmail.com 
Dr Sasmita Swain  SCB Medical College  Department of Obstetrics and Gynaecology, Behera Colony, Mangalabag, Cuttack, Odisha 753001
Cuttack
ORISSA 		 9861085727

drsasmitaswain@gmail.com 
Dr Charan pandurang Lanjewar  Seth GS Medical College Gymkhana  Research room, Department of Cardiology, CVTC building, ground floor, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 		 9769133740

charanlanjewar@kem.edu 
Dr Aamir Rashid  Sher-I-Kashmir Institute.Of Medical Sciences  Department of Cardiology, Room no: 19, Old library, Faculty block, 3rd floor, SKIMS Main Rd, Soura, Srinagar, Jammu and Kashmir 190011
Srinagar
JAMMU & KASHMIR 		 9419330159

aamirrashid11@yahoo.co.in 
Dr Kavitha Tyagi  Sir Gangaram Hospital  Clinical Research Room, 5th floor , Kitchen Building, Lift No:12, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi, 110060
Central
DELHI 		 8373987601

drkavitatyagi@gmail.com 
Dr Durga Prasad Rai  Sir Thutob Namgyal Memorial Hospital  Room No-2, HOD Office , Department of Cardiology, S.T.N. M. Multispeciality Hospital, Sochakgang, Gangtok-737102 Sikkim
East
SIKKIM 		 9775447193

dprai2010cardio@gmail.com 
Dr Bhupesh R Shah  Smt. NHL Municipal Medical College  Department of Cardiology, Pritan Rai Cross Road, Ellise Bridge, Paldi, Ahmedabad, Gujarat 380006
Ahmadabad
GUJARAT 		 9825032373

shahbhupesh1@gmail.com 
Dr Rajarajeswari  Thanjavur Medical College  Department of Obstetrics and Gynaecology, HOD room, Medical College Rd, Thanjavur, Tamil Nadu 613004
Thanjavur
TAMIL NADU 		 9487632069

drrrrpanju@gmail.com 
Dr Pooja Vyas  U N Mehta Institute of Cardiology & Research Centre, Ahmedabad  Department of Cardiology, No. 1, Civil Hospital Rd, opp. Un Mehta Hospital Gate, Haripura, Asarwa, Ahmedabad, Gujarat 380004
Ahmadabad
GUJARAT 		 9925004922

poojavyaskothari@gmail.com 
Dr Sandeep Bansal  Vardhman Mahavir Medical College & Safdarjung Hospital  Department of Cardiology, 754, Super Speciality block, Mahatma Gandhi Road, Safdarjung Campus, Ansari Nagar West, New Delhi, Delhi 110029
New Delhi
DELHI 		 9810543368

drsbansal2000@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 55  
Name of Committee  Approval Status 
BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL ETHICS COMMITTEE  Approved 
BIOMEDICAL RESEARCH ETHICS COMMITTEE, Pt.B.D.Sharma PGIMS/ UHS, Rohtak  Approved 
ETHICS AND SCIENTIFIC REVIEW COMMITTEE, M.G.M.MEDICAL COLLEGE  Approved 
Ethics Committee of Amrita School of medicine  Approved 
ETHICS COMMITTEE OF BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE  Approved 
ETHICS COMMITTEE, ARMED FORCES MEDICAL COLLEGE  Approved 
ETHICS COMMITTEE, GSVM, MEDICAL COLLEGE, KANPUR  Approved 
ETHICS COMMITTEE, GUNTUR MEDICAL COLLEGE & GOVT. GENERAL HOSPITAL  Approved 
ETHICS COMMITTEE, OSMANIA MEDICAL COLLEGE  Approved 
ETHICS COMMITTEE, S.M.S MEDICAL COLLEGE  Approved 
ETHICS COMMITTEE, S.P.MEDICAL COLLEGE, BIKANER  Approved 
ETHICS COMMITTEE- AIMS,THRISSUR  Approved 
INSTITUITIONAL ETHICS COMMITTEE, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL  Approved 
INSTITUITIONAL ETHICS COMMITTEE, MEDICAL COLLEGE, KOLKATA  Approved 
INSTITUITIONAL ETHICS COMMITTEE, SHER-I-KASHMIR INSTITUTE OF MEDICAL SCIENCES  Approved 
INSTITUITIONAL ETHICS COMMITTEE- CIHSR  Approved 
INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, DELHI  Approved 
INSTITUTE ETHICS COMMITTEE,, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR  Approved 
INSTITUTIONAL ETHICS COMMITTE, M/S. KING GEORGE HOSPITAL VISHAKAPATNAM  Approved 
Institutional Ethics Committee (Human Studies) for Observational Studies-JIPMER  Approved 
INSTITUTIONAL ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA  Approved 
INSTITUTIONAL ETHICS COMMITTEE FOR CLINICAL TRIAL, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NAGPUR  Approved 
INSTITUTIONAL ETHICS COMMITTEE FOR FACULTY RESEARCH AIIMS BHUBANESWAR  Approved 
INSTITUTIONAL ETHICS COMMITTEE MAMC  Approved 
INSTITUTIONAL ETHICS COMMITTEE UNMICRC  Approved 
INSTITUTIONAL ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR  Approved 
INSTITUTIONAL ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA  Approved 
INSTITUTIONAL ETHICS COMMITTEE, BURDWAN MEDICAL COLLEGE  Approved 
INSTITUTIONAL ETHICS COMMITTEE, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH  Approved 
INSTITUTIONAL ETHICS COMMITTEE, DAYANAND MEDICAL COLLEGE  Approved 
INSTITUTIONAL ETHICS COMMITTEE, GAJRA RAJA MEDICAL COLLEGE, GWALIOR  Approved 
INSTITUTIONAL ETHICS COMMITTEE, GAUHATI MEDICAL COLLEGE & HOSPITAL, GUWAHATI  Approved 
INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT MEDICAL COLLEGE, KOZHIKODE  Approved 
INSTITUTIONAL ETHICS COMMITTEE, KING GEORGES MEDICAL UNIVERSITY  Approved 
INSTITUTIONAL ETHICS COMMITTEE, M.K.C.G. MEDICAL COLLEGE  Approved 
INSTITUTIONAL ETHICS COMMITTEE, MADRAS MEDICAL COLLEGE, CHENNAI  Approved 
INSTITUTIONAL ETHICS COMMITTEE, MADURAI MEDICAL COLLEGE & GOVT. RAJAJI HOSPITAL, MADURAI  Approved 
INSTITUTIONAL ETHICS COMMITTEE, NORTH EASTERN INDIRA GANDHI REGIONAL INSTITUTE OF HEALTH & MEDICAL SCIENCES  Approved 
INSTITUTIONAL ETHICS COMMITTEE, Pt JNM MC, Raipur  Approved 
INSTITUTIONAL ETHICS COMMITTEE, R.N.T.MEDICAL COLLEGE  Approved 
INSTITUTIONAL ETHICS COMMITTEE, RIMS, RANCHI  Approved 
INSTITUTIONAL ETHICS COMMITTEE, S.C.B.MEDICAL COLLEGE & HOSPITAL  Approved 
INSTITUTIONAL ETHICS COMMITTEE, SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES  Approved 
INSTITUTIONAL ETHICS COMMITTEE, SETH GS MEDICAL COLLEGE AND KEM HOSPITAL  Approved 
INSTITUTIONAL ETHICS COMMITTEE, Smt.NHL Municipal Medical College  Approved 
INSTITUTIONAL ETHICS COMMITTEE, THANJAVUR MEDICAL COLLEGE  Approved 
INSTITUTIONAL ETHICS COMMITTEE, VARDHMAN MAHAVIR MEDICAL COLLEGE  Approved 
INSTITUTIONAL ETHICS COMMITTEE,, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH  Approved 
INSTITUTIONAL ETHICS COMMITTEE-HIMS, HASSAN  Approved 
Institutional Human Ethics Committee, Coimbatore Medical College  Approved 
Institutional Research Advisory Committee, Goa Medical College  Approved 
INSTITUTIONAL REVIEW BOARD, CHRISTIAN MEDICAL COLLEGE  Approved 
IPGME&R Research Oversight committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Approved 
SMIMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O994||Diseases of the circulatory systemcomplicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Enhanced usual Care Group  Comparator group will include the sites randomized to the enhanced usual care. These sites will follow the usual care followed as before for managing pregnant women. This phase will last for about twenty four months (till all the patients enrolled during the phase, complete their pregnancy and the mandatory follow up) 
Intervention  Protocolised Cardio Obstetric Care  A protocol for managing heart disease in pregnant women will be developed in the first observational phase. The sites randomized to Protocolised Cardio Obstetric Care group, will follow the management pattern as suggested by the newly developed protocol. This phase will last for about twenty four months (till all the patients enrolled during the phase, complete their pregnancy and the mandatory follow up) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  All consecutive pregnant women with
known or newly detected heart diseases mentioned below, seeking antenatal care in the participating sites will be eligible for inclusion.
Structural Heart disease- congenital or acquired
Arrhythmic heart disease
Ischemic heart disease
Aortic diseases
Pulmonary vascular disease

 
 
ExclusionCriteria 
Details  Patients with hypertensive disorders of pregnancy or gestational diabetes mellitus without any of the above inclusion criteria
Patients below the age of 18
Patients who are not able to or not willing to give informed consent.
Patients who are part of another trial
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Composite Maternal adverse events as mentioned below
Maternal death
Resuscitated cardiac arrest

New or worsening maternal heart failure requiring treatment escalation or hospitalization (Left-sided heart failure (HF) or pulmonary edema; right-sided HF)

New onset or recurrent sustained cardiac arrhythmia requiring treatment

Systemic thrombo-embolism

Hemorrhagic complications (Major bleed or minor bleed as per ISTH Criteria)

Venous thrombo-embolism (DVT / PE / Invictus trial)

Cerebrovascular accident / Stroke

Infective endocarditis

Prosthetic valve thrombosis

Aortic dissection developing during pregnancy

Acute coronary syndrome / SCAD

Performance of urgent cardiac intervention up to 6th postpartum week
( like PTMC, Pericardiocentesis, RF ablation)

 		 42 days after delivery
 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal Death  6 months 
Decline in NYHA functional class ≥ 2 during pregnancy  42 days after delivery 
Cardiac hospitalization
 		 Antenatal period and upto 6 weeks in the post natal period 
PPH
 		 Peripartum Period 
Gestational diabetes
 		 Antenatal Period 
Mode of delivery (If LSCS – emergency LSCS / elective LSCS, Cardiac indication / obstetric indication)
 		 Peripartum Period 
Hypertensive disorders of pregnancy
 		 Antenatal Period 
PROM- Premature rupture of membranes
 		 During delivery 
Urgent unplanned cardiac hospitalization  Antenatal period and upto 6 weeks in the post natal period 
Miscarriage (fetal loss up to 20 weeks)
 		 First 20 weeks in the antenatal period 
Fetal loss after 20th week.
 		 First 20 weeks in the antenatal period 
Small for gestational age  During Delivery 
Low birth weight (less than 2.5 kg irrespective of gestational age)
 		 During delivery 
Preterm birth
 		 During Delivery 
Admission to neonatal intensive care unit
 		 6 weeks in the post natal period 
Neonatal death
 		 6 weeks in the post natal period 
Congenital anomalies (including CHD) in the new born
 		 6 weeks in the post natal period 
Elective cardiac interventions done (Lysis, ablation, Balloon, surgery)  Antenatal period and upto 6 weeks in the post natal period 
Duration of stay in ICU
 		 Antenatal period and upto 6 weeks in the post natal period 
 
Target Sample Size   Total Sample Size="3300"
Sample Size from India="3300" 
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)   01/04/2024 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 https://doi.org/10.1016/j.amjcard.2026.05.001 Rationale And Design Of The NPAC-India Study: A Prospective Multicenter Observational Study Of Pregnant Women With Heart Disease 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Background: Heart disease complicates 1- 4% of pregnancies. The number of women presenting with heart disease during pregnancy is increasing. Despite the reduction in maternal mortality in India over the past two decades, cardiac contribution to maternal mortality is increasing. Data on pregnant women with heart disease (PWWHD) representative of our nation, local risk scores and guidelines /protocols are lacking. 


Novelty: A pragmatic protocol for managing PWWHD will be developed and tested.  Data representative of India will be collected. Findings may influence care and pregnancy outcomes in other low and middle-income countries. 


Aims and Objectives: To study profile and feto-maternal outcomes of PWWHD in India, to understand the existing practice patterns in care offered to PWWHD in India, develop a customized protocol for managing PWWHD appropriate for India, and assess its impact on outcomes compared to usual care

To develop a regional score for risk stratifying PWWHD in India to enable targeted management.


Methods: We propose a multicentric study covering 24 states in India. During Phase 1 of the study, the practice patterns in managing PWWHD will be assessed across 50 centres in India and a step-wise protocol to improve outcome will be developed. During phase 2, a cluster randomized study will be conducted among 40 average-large centres across India to assess the effectiveness of the protocolized cardio-obstetric care in improving outcomes compared to usual care. 


Expected outcome: A protocol for managing PWWHD in India will be developed. A regional score for risk-stratifying PWWHD in India will be developed and validated. The contribution of heart disease to maternal mortality in India will be reduced in the years that follow.


 
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