This study will be conducted as a prospective cohort study, enrolling all eligible womenin their first trimester of pregnancy during a baseline visit during week 6-13 ofpregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary,secondary, and tertiary care and the obstetric department delivers about 10,000 babies ayear. The hypothesis is that co-infection of other respiratory viruses (ORV),particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes inmothers and babies and could address the current standard of care in India to notvaccinate pregnant women during pregnancy, by either encouraging vaccination against bothviruses before planning a pregnancy or during pregnancy based on global data supportingthe safety of this strategy.
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.
Other: Exposures
COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn
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).
Boston University School of Public Health, Global Health
Boston, Massachusetts, United States
Government. Medical College Hospital
Nagpur, India
Patricia Hibberd, MD PhD
617-358-2046
plh0@bu.edu
Aboli Goghari, MPH
617-358-2310
agoghari@bu.edu