Clinical trial NCT06168019: Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Official title: Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza
COVID-19
SARS-COV-2 Infection
Other Respiratory Viruses
Perinatal Morbidity
Infant Morbidity
Keywords: Pregnant women
Government Medical College Hospital, Nagpur, India
Covid-19 vaccination
Antenatal care
Postpartum
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Lata Medical Research Foundation, Nagpur
First posted: 2023-12-13
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Maternal composite adverse outcome variable
timeFrame: 1 year
Secondary outcomes:
measure: Perinatal composite adverse outcome variable
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Public Health, Global Health
state: Massachusetts
city: Nagpur
country: India
facility: Government. Medical College Hospital
Study officials:
affiliation: Boston University School of Public Health, Global Health
name: Patricia Hibberd, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lata Medical Research Foundation, Nagpur India
name: Archana Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: