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CTRI Number  CTRI/2022/03/041343 [Registered on: 24/03/2022] Trial Registered Prospectively
Last Modified On: 24/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Postdelivery follow up of women who delivered in a tertiary care labor room of a teaching institute in India 
Scientific Title of Study   Comprehensive Postnatal Tracking of an Optimally Managed Cohort towards developing National guidelines for postnatal care 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2020-9453  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jiji Mathews 
Designation  Professor and Head of the Department 
Affiliation  Christian Medical College Vellore 
Address  7th floor OG 5 Office ISSCC Building Christian Medical College and Hospital Ida Scudder Road Vellore
The Principal Carman Block Christian Medical College Campus Bagayam Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9790607237  
Fax  04162232035  
Email  coronistrial@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jiji Mathews 
Designation  Professor and Head of the Department 
Affiliation  Christian Medical College Vellore 
Address  7th floor OG 5 Office ISSCC Building Christian Medical College and Hospital Ida Scudder Road Vellore
The Principal Carman Block Christian Medical College Campus Bagayam Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9790607237  
Fax  04162232035  
Email  coronistrial@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jiji Mathews 
Designation  Professor and Head of the Department 
Affiliation  Christian Medical College Vellore 
Address  7th floor OG 5 Office ISSCC Building Christian Medical College and Hospital Ida Scudder Road Vellore
The Principal Carman Block Christian Medical College Campus Bagayam Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9790607237  
Fax  04162232035  
Email  coronistrial@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi 110029 India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  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 
Indian council of Medical Research  Ansari Nagar New Delhi India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jiji Mathews  Christian Medical College and Hospital  Department of Obstetrics and Gynecology OG 5 Office 7th Floor ISSCC Building, Christian Medical Hospital
Vellore
TAMIL NADU 		 9790607237
04162232035
coronistrial@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution review Board Christian Medical College vellore India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O909||Complication of the puerperium, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIl   Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All antenatal women who delivered in a large self-financed not-for-profit tertiary center after 22 weeks of gestation. 
 
ExclusionCriteria 
Details  All women who did not deliver in the center or had an abortion at less than 22 weeks of gestation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Number of unscheduled visits after discharge before 14 weeks post partum for mother or child.
2.Reasons for unscheduled visits after discharge for mother and child.
 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Unhealed site requiring medical or surgical treatment.
2. Anemia
3. Increased BMI
4. BP 130/90
5. Pain in abdomen/Pelvis
6. Urinary Problem
7. Bowel Problem
8. Musculoskeletal problem
9. Contraception
10. Breast problem.
11. Significant neonatal problems.
12. Significant maternal mental issues.
13. Breast feeding issues.
14. Social Support- Family APGAR
15. Health Economics

 		 3, months 9,months and one and half years. 
 
Target Sample Size   Total Sample Size="14000"
Sample Size from India="14000" 
Final Enrollment numbers achieved (Total)= "12000"
Final Enrollment numbers achieved (India)="12000" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/04/2022 
Date of Study Completion (India) 31/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2022 
Estimated Duration of Trial   Years="2"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 R GM, Pricilla RA, Kurian S The PoNTiS Collaborative Group, et alStudy protocol: ‘a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India’BMJ Open 2022;12:e063497. doi: 10.1136/bmjopen-2022-063497 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [coronistrial@yahoo.co.in].

  6. For how long will this data be available start date provided 01-10-2024 and end date provided 31-10-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 The focus of the global health community has shifted from coverage to quality of care from antenatal and intrapartum care to postnatal care. There has been an impressive improvement in maternal and newborn mortality with the completion of millennium development goals. However, as we embark into a new era of sustainable development goals (SDGs) the emphasis on morbidity and quality of care will soon take centre stage. The postpartum phase is one such phase that very little is known in our subcontinent. There is an urgent need to know details of maternal medical, physical and mental health, newborn health, social support system, and barriers for contraception, all of which are interlinked for optimal health care.

 Outcomes of a large cohort of about 14,000 deliveries per year in our institution for over 18 years have been published in the British Journal of Obstetrics and Gynaecology in June 2019. The overall caesarean section rate has been maintained close to 33% with a low overall perinatal mortality of 16 per 1000. Moreover, asphyxial admissions to neonatal intensive care unit of 0.7 per 1000 are comparable to most international centres. We also have data published on surgical wound infection rates following vaginal and cesarean deliveries which are 2-3% and 3-4% respectively. However, these women and the neonates are discharged on the third day or latest by a week after which we have no information of their well-being. 

Our tertiary centre and its satellite centers are part of a not-for-profit organization catering mainly to low and middle-income families. Information from this cohort may give us some salient insights. Our department was one of two centres from India that participated in the "CORONIS" study that studied techniques of cesarean outcomes with a 3-year follow-up. It was indeed surprising that suicide or homicide were major causes for maternal deaths in the Cohort of women that were followed up.
 A Health assessment questionnaire that assesses salient maternal and newborn outcomes at intervals of 3 months, 9 months, one and half years would help us obtain extensive information of the postpartum period. This would then help us make concrete guidelines and recommendations for the care in the postpartum period.

The main objectives of this proposal is to address the unmet maternal health needs in the year following pregnancy through the assessment of, 

1. maternal medical and physical health 
2. maternal mental health.
3. new born health and barriers to breastfeeding 
4. Social support systems and framework 
5. Determinants and barriers for contraception
6. Development of guidelines for pragmatic cost-effective postpartum care

 
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