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	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)	Open to Recruitment
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.