Recruiting

Influenza & COVID-19

Sponsor:

Boston University

Code:

NCT06168019

Conditions

Influenza

COVID-19

SARS-COV-2 Infection

Other Respiratory Viruses

Perinatal Morbidity

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Exposures

Study Details

Brief summary:

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

Influenza

COVID-19

SARS-COV-2 Infection

Other Respiratory Viruses

Perinatal Morbidity

Study ID

NCT06168019

Start date

Dec 26, 2023

Status verified date

Nov, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

Women aged 18 to 50 years registering for antenatal care (ANC) at Government Medical College Hospital (GMC) Nagpur, India

  • 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

Exclusion Criteria:

  • 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).

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India.

Interventions

Exposures

COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn

Primary outcome measure

  • Maternal composite adverse outcome variable [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Patricia Hibberd, MD PhD

617-358-2046plh0@bu.edu

Aboli Goghari, MPH

617-358-2310agoghari@bu.edu

Locations

Boston University School of Public Health, Global Health

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Patricia Hibberd, MD PhD

plh0@bu.edu

Aboli Goghari, MPH

agoghari@bu.edu

More Information

Sponsor

Boston University

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2025-11-28.