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Influenza & COVID-19 Study in Pregnant Women in India

This study, taking place in India, is looking at how common and severe COVID-19 and the flu (influenza) are in pregnant women. It also wants to understand how these infections, and other common respiratory viruses (ORV), might affect the health of mothers and their babies. Researchers are hoping to enroll 10,000 pregnant women between 18 and 50 years old who are less than 14 weeks pregnant and receiving care at Government Medical College Hospital in Nagpur. The main goal is to see if these infections increase the risk of problems for the mother, with outcomes measured up to one year after delivery. This observational study will help determine if current care standards for pregnant women in India should be updated, possibly by encouraging vaccination.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include 10,000 participants.
What's involved
You would receive standard medical care throughout your pregnancy, labor, delivery, and after birth. Study visits and blood draws will happen alongside your regular appointments.
Compensation
Not stated in the trial record.
Follow-up
Your health outcomes will be monitored for up to one year after delivery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06168019

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

Recruiting
Not specifiedAges 18–50Observational
Boston University
~10,000 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:Exposures

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maternal composite adverse outcome variable
Measured over 1 year

Conditions

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

Explore related trials

COVID-19 InfectionInfant MorbidityInfluenzaPerinatal Morbidity

Where it's being run

2 sites across 2 states
Massachusetts1
India1

Study leadership

  • 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

Who to contact

Patricia Hibberd, MD PhD
[email protected]
617-358-2046
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Maternal composite adverse outcome variable1 year

    The maternal composite variable includes any of following 3 outcomes: * Preterm labour, defined as hospitalization for the management of onset of labor before fetus age 37 weeks, regardless of when birth occurs; * Pre-eclampsia with severe features, defined as the new onset of systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>110 mm Hg and proteinuria (World Health Organization (WHO) definition); * Mortality at any time between enrolment and day 42 post-partum/after miscarriage.