InfluenzaICOPENCT06168019
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
An observational study of Influenza and COVID-19, run by Boston University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Influenza, COVID-19, SARS-COV-2 Infection
- What is being tested?
- Exposures
- How many people
- 10,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Dec 2023to Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
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.
Who may be able to join
- 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;
Show all 10Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Boston University School of Public Health, Global Health
Boston, Massachusetts, 02118
Patricia Hibberd, MD PhD, plh0@bu.edu
Aboli Goghari, MPH, agoghari@bu.edu
India1 site, 1 recruiting
- Recruiting
Government. Medical College Hospital
Nagpur
Archana Patel, MD
About this study
Official title: Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India
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.
Read the detailed description
All pregnant women enrolled in the study will receive standard of care throughout their pregnancy, labor and delivery and post-partum to discharge. Wherever possible, study visits will coincide with regular antenatal (ANC) care and blood draws will be added to standard blood draws during ANC, labor and delivery and postpartum care. Women will be counselled about procedure to reduce the risk of acquiring ORV during pregnancy. Since this study is observational, we do not anticipate any specific safety concerns with study interviews and procedures, but the investigators will monitor potential adverse events to determine if they are likely or possibly study related.
PRIMARY OBJECTIVE: Determine the prevalence, incidence, and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 42 postpartum/after miscarriage on maternal outcomes. Secondary analysis will evaluate whether influenza/Other Respiratory Viruses (ORV) infection or COVID-19 vaccination modifies or mediates this risk.
SECONDARY OBJECTIVE: Determine the effect of maternal COVID-19 infection on the fetus and/or neonate during pregnancy through day 7 of life. Secondary analysis will focus on whether influenza/ORV or vaccination modifies, and pre-term birth mediates this risk.
EXPLORATORY OBJECTIVE: Characterize patterns and trajectories of host response/ inflammatory biomarkers as potential mediators of COVID-19 ± Influenza and ORV infection on progression to severe illness in pregnant women/mothers admitted to Government Medical College hospital with COVID-19. Modifiers include COVID-19 , Influenza and other ORV vaccinations.
- Conditions
- Influenza, COVID-19, SARS-COV-2 Infection, Other Respiratory Viruses, Perinatal Morbidity, Infant Morbidity
- Being tested
- Exposures
- Keywords
- Pregnant women, Government Medical College Hospital, Nagpur, India, Covid-19 vaccination, Antenatal care, Postpartum
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposuresOther
COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exposures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Perinatal composite adverse outcome variable
The perinatal adverse outcomes includes any of the following 3 outcomes:
- Preterm birth, defined as gestational age of <37 weeks at birth, based on gestational age dating by ultrasound obtained before study enrolment;
- Neonatal critical illness, defined as any sign of critical illness in the newborn and/or continued hospitalization after day 7 of life;
- Perinatal Mortality, defined as fetal mortality after week 20 of pregnancy through neonatal death by day 7 of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start26 Dec 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lata Medical Research Foundation, Nagpur
- Responsible party
- Sponsor
- Investigators
- Patricia Hibberd, MD PhD, Principal investigator, Boston University School of Public Health, Global HealthArchana Patel, MD, Principal investigator, Lata Medical Research Foundation, Nagpur India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168019
- Sponsor's protocol ID
- H-43541
- Other IDs
- UG1HD078439
- Acronym
- ICOPE
- Status last verified
- Nov 2025
- First submitted
- 12 Dec 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided