NCT06168019

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Dec 2023Jun 2028

First Submitted

Initial submission to the registry

December 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 26, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

4.4 years

First QC Date

December 12, 2023

Last Update Submit

November 26, 2025

Conditions

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

Keywords

Pregnant womenGovernment Medical College Hospital, Nagpur, IndiaCovid-19 vaccinationAntenatal carePostpartum

Outcome Measures

Primary Outcomes (1)

  • Maternal composite adverse outcome variable

    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.

    1 year

Secondary Outcomes (1)

  • Perinatal composite adverse outcome variable

    1 year

Study Arms (1)

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.

Other: Exposures

Interventions

ExposuresOTHER

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

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

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India. Women will be aged 18-50 and can be from any race or ethnic group.

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston University School of Public Health, Global Health

Boston, Massachusetts, 02118, United States

RECRUITING

Government. Medical College Hospital

Nagpur, India

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for COVID-19, influenza and ORV antibodies and potential modifiers of infection will be drawn at a maximum of four time points - baseline (week 6-13 of pregnancy), at study visit 3 (week 28-34), at study visit 4 (week 37-prior to delivery) of pregnancy and between delivery and day 42-70 postpartum/after miscarriage. In addition a random subset of 200 subjects will be invited to provide nasopharyngeal (NP)swabs during all 4 study visits and between delivery and day 7 postpartum (prior to discharge) to track asymptomatic viral infection.

MeSH Terms

Conditions

Influenza, HumanCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung Diseases

Study Officials

  • Patricia Hibberd, MD PhD

    Boston University School of Public Health, Global Health

    PRINCIPAL INVESTIGATOR

  • Archana Patel, MD

    Lata Medical Research Foundation, Nagpur India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Hibberd, MD PhD

CONTACT

617-358-2046plh0@bu.edu

Aboli Goghari, MPH

CONTACT

617-358-2310agoghari@bu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 13, 2023

Study Start

December 26, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations

US(1)IN(1)