Exposures: COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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 outcome measure(s)
Maternal composite adverse outcome variable — 1 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.
Trial sites (2)
Facility
City
Region
Status
Boston University School of Public Health, Global Health
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.