RECRUITING

Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India

Description

This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.

Conditions

InfluenzaCOVID-19SARS-COV-2 InfectionOther Respiratory VirusesPerinatal MorbidityInfant Morbidity
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Related Conditions:

InfluenzaCOVID-19SARS-COV-2 InfectionOther Respiratory VirusesPerinatal MorbidityInfant Morbidity

Study Overview

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Study Details

Study overview

This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.

Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India

Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India

Condition
Influenza
Intervention / Treatment

-

Contacts and Locations

Boston

Boston University School of Public Health, Global Health, Boston, Massachusetts, United States, 02118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Estimated Gestational Age at registration \<14 weeks based on ultrasound report at the baseline study visit;
  • * Intends to receive pregnancy, labor and delivery and neonatal care at GMC;
  • * Plans to live within the city limits of Nagpur throughout their pregnancy and labor and delivery to facilitate access to GMC for evaluation of ILI and COVID-19 symptoms;
  • * Willing to be contacted two times per week by call or text for ILI/ COVID-19 symptom screening and return to GMC for evaluation and an NP swab/evaluation if symptoms are reported;
  • * Willing to take temperature with the provided digital thermometer, and maintain a symptom diary after training;
  • * Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;
  • * Willing to permit venous blood draws on at least 4 timepoints --1) Baseline study visit, 2)28-34 weeks, 3) 37 weeks - prior to delivery and 4) after delivery;
  • * Willing to permit blood draws if hospitalized at GMC for COVID-19 infection;
  • * Willing to consent to participate in the study
  • * Anyone who is deemed to have limited decision-making capacity as defined by Boston University IRB i.e. Substantial impairment of cognitive functions (e.g. attention, comprehension, memory, and intellect), or conditions that might affect their cognitive functions.
  • * Anyone who is deemed to have limited capacity to consent as defined by Boston University Institutional Review Board (IRB) i.e. The ability to provide legally effective consent to enroll in a research study (AAHRPP definition).

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston University,

Patricia Hibberd, MD PhD, PRINCIPAL_INVESTIGATOR, Boston University School of Public Health, Global Health

Archana Patel, MD, PRINCIPAL_INVESTIGATOR, Lata Medical Research Foundation, Nagpur India

Study Record Dates

2028-06