Influenza and COVID study in pregnant women and their newbor
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J100- Influenza due to other identifiedinfluenza virus with pneumonia
- Registration Number
- CTRI/2022/12/048428
- Lead Sponsor
- ational Institute of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Eligibility Criteria :
1. Women ages 18 to 50 years registering for ANC at GMC Hospital Nagpur;
2. Intending to be followed throughout pregnancy, labor and delivery and neonatal care at GMC;
3. Living within the city limits of Nagpur to facilitate access to GMC for evaluation of ILI and COVID symptoms;
4. Estimated Gestational Age at registration <13 weeks based on ultrasound at 1st ANC visit
5. 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;
6. Willing to take temperature with the provided digital thermometer, after training;
7. Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;
8. 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;
9. Willing to consent.
1. All those do not meet eligibility criteria and not willing to consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant womenTimepoint: Day 7, post-partum
- Secondary Outcome Measures
Name Time Method Characterize patterns and trajectories of host response/inflammatory biomarkers as <br/ ><br>potential mediators of COVID-19±ORV infection on progression to severe illness in pregnant women/mothers <br/ ><br>admitted with COVID-19Timepoint: Endline;Effect of maternal COVID-19 infection on the fetus and/or neonateTimepoint: Day 7, Post-partum