RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-26
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06168019

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Estimated Gestational Age at registration \<14 weeks based on ultrasound report at the baseline study visit;
  2. * Intends to receive pregnancy, labor and delivery and neonatal care at GMC;
  3. * 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;
  4. * 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;
  5. * Willing to take temperature with the provided digital thermometer, and maintain a symptom diary after training;
  6. * Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;
  7. * 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;
  8. * Willing to permit blood draws if hospitalized at GMC for COVID-19 infection;
  9. * Willing to consent to participate in the study
  1. * 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.
  2. * 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).

Contacts and Locations

Study Contact

Patricia Hibberd, MD PhD
CONTACT
617-358-2046
plh0@bu.edu
Aboli Goghari, MPH
CONTACT
617-358-2310
agoghari@bu.edu

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-26
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-12-26
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Pregnant women
  • Government Medical College Hospital, Nagpur, India
  • Covid-19 vaccination
  • Antenatal care
  • Postpartum

Additional Relevant MeSH Terms

  • Influenza
  • COVID-19
  • SARS-COV-2 Infection
  • Other Respiratory Viruses
  • Perinatal Morbidity
  • Infant Morbidity