Influenza & COVID Obstetric and Perinatal Epidemiology (ICOPE) Study in India
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- National Institute of Health
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women
Study Overview
Brief Summary
| Study Objectives |
AIM 1: Determine the prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 7 postpartum on maternal outcomes. We hypothesize that a composite maternal outcome (preterm labor, preeclampsia with severe features and/or mortality) will be higher among those with COVID-19 infection vs. those with no COVID infection. Secondary analysis will evaluate whether influenza/ORV infection or vaccination modifies and pre-term birth mediates this risk. Public Health Outcome: Data for public health preparedness.
AIM 2: Determine the effect of maternal COVID-19 infection on the fetus and/or neonate through day 7 of life. We hypothesize that a composite fetal/neonatal primary outcome (preterm birth, newborn critical illness and/or perinatal mortality) will be higher among mothers with COVID-19 infection vs. No COVID infection. Secondary analysis will focus on whether influenza/ORV or vaccination modifies and pre-term birth mediates this risk. Public Health Outcome: Data on at risk pregnancies and effect of vaccines on outcomes.
AIM 3: (EXPLORATORY) Characterize patterns and trajectories of host response/inflammatory biomarkers as potential mediators of COVID-19±ORV infection on progression to severe illness in pregnant women/mothers admitted with COVID-19. Modifiers include vaccination. Public Health Outcome: Potential targets for treatment/prevention.
Study Process
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Eligibility Criteria :
- •Women ages 18 to 50 years registering for ANC at GMC Hospital Nagpur;
- •Intending to be followed throughout pregnancy, labor and delivery and neonatal care at GMC;
- •Living within the city limits of Nagpur to facilitate access to GMC for evaluation of ILI and COVID symptoms;
- •Estimated Gestational Age at registration <13 weeks based on ultrasound at 1st ANC visit
- •Willing to be contacted two times per week by call or text for ILI/COVID symptom screening and return to GMC for an NP swab/evaluation if symptoms are reported;
- •Willing to take temperature with the provided digital thermometer, after training;
- •Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;
- •Willing to permit blood draws or finger sticks for DBS at all ANC visits and if symptoms occur through day 7 postpartum and during visits to GMC or admission for respiratory illness;
- •Willing to consent.
Exclusion Criteria
- •All those do not meet eligibility criteria and not willing to consent.
Outcomes
Primary Outcomes
Prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women
Time Frame: Day 7, post-partum
Secondary Outcomes
- Effect of maternal COVID-19 infection on the fetus and/or neonate(Day 7, Post-partum)
- Characterize patterns and trajectories of host response/inflammatory biomarkers as(potential mediators of COVID-19±ORV infection on progression to severe illness in pregnant women/mothers)