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Clinical Trial Details (PDF Generation Date :- Sat, 16 Sep 2023 01:12:09 GMT) CTRI Number CTRI/2020/05/025423 [Registered on: 28/05/2020] - Trial Registered Prospectively Last Modified On 12/05/2021 Post Graduate Thesis No Type of Trial Type of Study Study Design Observational Retrospective and Prospective Cohort 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 Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL Name Designation Affiliation Address Phone Fax Email Name Designation Affiliation Address Phone Fax Email Name Designation Affiliation Address Identifier NIL Details of Principal Investigator Dr Rahul Gajbhiye Scientist D DBT Wellcome Trust India Alliance Clinical and Public Health Intermediate Fellow ICMR-NIRRH Department of Clinical Research ICMR-National Institute for Research in Reproductive Health J M Street Parel Mumbai Mumbai MAHARASHTRA 400012 India 02224192036 gajbhiyer@nirrh.res.in Details Contact Person (Scientific Query) Dr Rahul Gajbhiye Scientist D DBT Wellcome Trust India Alliance Clinical and Public Health Intermediate Fellow ICMR-NIRRH Department of Clinical Research ICMR-National Institute for Research in Reproductive Health J M Street Parel Mumbai Mumbai MAHARASHTRA 400012 India 02224192036 gajbhiyer@nirrh.res.in Details Contact Person (Public Query) Dr Rahul Gajbhiye Scientist D DBT Wellcome Trust India Alliance Clinical and Public Health Intermediate Fellow ICMR-NIRRH Department of Clinical Research ICMR-National Institute for Research in Reproductive Health J M Street Parel Mumbai Mumbai MAHARASHTRA 400012 page 1 / 4 PDF of TrialCTRI Website URL - http://ctri.nic.in Phone Fax Email India 02224192036 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 Name Address Primary Sponsor Details ICMR NATIONAL INSTITUTE FOR RESEARCH IN REPRODUCTIVE HEALTH ICME NIRRH J M Street Parel Mumbai India 400012 Type of Sponsor Research institution Name Address Medical Education and Drugs Department Government of Maharashtra G T Hospital Compound, 9th Floor, New Mantralaya, Mumbai Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study List of Countries India Name of Principal Investigator Name of Site Site Address Phone/Fax/Email Dr Rakesh Waghmare Government Medical Colleges under Medical Education and Drugs Department Government of Maharashtra Dr Niraj Mahajan Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Mumbai 9975629676 rakeshbw0326@gmail.c om 9004696920 nirajdr@hotmail.com Medical Education and Drugs Department, Government of Maharashtra, G T Hospital Compound, 9th Floor, New Mantralaya, Mumbai 400001 Mumbai MAHARASHTRA Department of Obstetrics and Gynecology Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Mumbai, 400 008 Mumbai MAHARASHTRA Details of Ethics Committee Name of Committee Approval Status Date of Approval Is Independent Ethics Committee?
Approved 12/05/2020 Approved 27/05/2020 Yes Yes Ethics Commiteee of Medical Colleges Under MEDD Ethics Committee for Academic Research Projects (ECARP), T.N.
Medical College & BYL Nair Hospital Regulatory Clearance Status from DCGI Health Condition / Problems Studied Status Not Applicable Health Type Patients Date No Date Specified Condition Coronavirus as the cause of diseases classified page 2 / 4 PDF of TrialCTRI Website URL - http://ctri.nic.in Intervention / Comparator Agent Inclusion Criteria Patients Type Age From Age To Gender Details elsewhere Other specified viral diseases Name Details Inclusion Criteria 18.00 Year(s) 45.00 Year(s) Female Part A <br/> 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 <br/> Part B <br/> 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 Exclusion Criteria Exclusion Criteria Details Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints at the end of 24 months 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 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 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) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) 01/06/2020 No Date Specified Years=2 Months=0 Days=0 Not Applicable Open to Recruitment page 3 / 4 PDF of TrialCTRI Website URL - http://ctri.nic.in Publication Details NIL Brief Summary 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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