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CTRI Number  CTRI/2020/05/025423 [Registered on: 28/05/2020] Trial Registered Prospectively
Last Modified On: 30/05/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective and Prospective Cohort 
Study Design  Other 
Public Title of Study   Pregnancy and COVID-19 Registry  
Scientific Title of Study   National Registry of Pregnant Women with COVID-19 in India  
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Gajbhiye  
Address  Department of Clinical Research ICMR-National Institute for Research in Reproductive Health J M Street Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192036  
Fax    
Email  gajbhiyer@nirrh.res.in  
 
Details Contact Person
Scientific Query
 
Name  Dr Rahul Gajbhiye  
Address  Department of Clinical Research ICMR-National Institute for Research in Reproductive Health J M Street Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192036  
Fax    
Email  gajbhiyer@nirrh.res.in  
 
Details Contact Person
Public Query
 
Name  Dr Rahul Gajbhiye  
Address  Department of Clinical Research ICMR-National Institute for Research in Reproductive Health J M Street Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192036  
Fax    
Email  gajbhiyer@nirrh.res.in  
 
Source of Monetary or Material Support  
ICMR National Institute for Rsearch in Reproductive Health Medical Education and Drugs Department Maharashtra TNMC and BYL Nair Hospital Mumbai  
 
Primary Sponsor  
Name  ICMR NATIONAL INSTITUTE FOR RESEARCH IN REPRODUCTIVE HEALTH  
Address  ICME NIRRH J M Street Parel Mumbai India 400012  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Medical Education and Drugs Department Government of Maharashtra   G T Hospital Compound, 9th Floor, New Mantralaya, Mumbai  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Waghmare   Government Medical Colleges under Medical Education and Drugs Department Government of Maharashtra   Medical Education and Drugs Department, Government of Maharashtra, G T Hospital Compound, 9th Floor, New Mantralaya, Mumbai 400001
Mumbai
 
9975629676

rakeshbw0326@gmail.com 
Dr Niraj Mahajan  Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Mumbai   Department of Obstetrics and Gynecology Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Mumbai, 400 008
Mumbai
 
9004696920

nirajdr@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Commiteee of Medical Colleges Under MEDD   Approved 
Ethics Committee for Academic Research Projects (ECARP), T.N. Medical College & BYL Nair Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
Patients  Other specified viral diseases 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Part A
Medical Case records of pregnant women with COVID-19 admitted from 1st January to 31st May 2020 will be analyzed. The records of the Pregnant women died due to COVID-19 will also be analyzed
Part B
Medical records of all pregnant and/ post-partum women with COVID-19 in Maharashtra from 01.06.2020 will be evaluated for prospective data entry in the registry  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Incidence of COVID-19 in pregnancy
2. Socio-demographic, epidemiological and clinical characteristics of pregnant women with COVID-19
3. Pregnancy outcomes in women with COVID-19
4. Neonatal outcomes in women with COVID-19
5. Response to treatment
6. Modes of transmission of COVID-19 from mother to child
 
at the end of 24 months  
 
Secondary Outcome  
Outcome  TimePoints 
National Clinical Database of Pregnant Women wit COVID-19   24 months  
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
NIL 
Brief Summary
Modification(s)  

Currently, there is a public health emergency due to COVID19, an infectious disease caused by a novel coronavirus which is now called as SARSCoV2. As on 20th  May, 2020, there are 47,89,205 cases with 3,18,789 deaths due to COVID19 worldwide and India has 1,06,750 total confirmed cases with 3, 303 deaths.  More than 39,000 cases are reported in Maharashtra State with more than 1300 deaths. SARSCoV2 had not been detected in humans before the current outbreak and hence limited information is available about its effect on people, almost negligible information is available in pregnant women. Earlier infections related to other viruses similar to the SARSCoV2 led to higher death rates in pregnant women and required special care of such women infected with coronaviruses. Currently, there is no information on impact of SARSCoV2 infection in pregnant women and their newborns in India. NIRRH  perceived a need to address the maternal and child health issues with the rise of COVID19 cases especially in Maharashtra State. The proposed study is developed in collaboration with Medical Education and Drugs Department, Government of Maharashtra and MCGM. Part A of the study is aimed to conduct the analysis of the hospital data of pregnant and post-partum women with COVID19 retrospectively at COVID19 Hospitals in Maharashtra State. The part B of the study will collect the data of pregnant and post-partum women with COVID-19 and their new-borns in an electronic record prospectively. The study will collect data on symptoms, maternal and newborn outcomes in pregnant women with COVID19 in Maharashtra State. The results of the Part A of the study will be useful for understanding the baseline information about COVID19 in pregnant women and their newborns in the state of Maharashtra. The results of Part B of the study will give detailed information on clinical presentation, maternal and newborn outcomes in pregnant women with COVID19 in Maharashtra State. This information will be useful to the Government of Maharashtra, Municipal Corporation of Greater Mumbai (MCGM) and other agencies to implement effective strategies to ensure the welfare of pregnant women and their children. 


 

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