Study on influenza and COVID-19 effects in pregnant women in India

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enroll pregnant women in their first trimester at Government Medical College Hospital in Nagpur, India, to assess the impact of co-infection with respiratory viruses, particularly COVID-19 and influenza, on maternal and neonatal outcomes. Participants will receive standard antenatal care while being monitored for symptoms and potential infections throughout their pregnancy and postpartum period. The study will also evaluate the role of vaccination against these viruses in mitigating risks associated with infections during pregnancy.

Why it matters

Who can join: the full rules

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).

Where it's running

• Boston University School of Public Health, Global Health
  Boston, Massachusetts, United States Recruiting
• Government. Medical College Hospital
  Nagpur, India Recruiting

Study contacts

• Principal investigator: Patricia Hibberd, MD PhD — Boston University School of Public Health, Global Health
• Study coordinator: Patricia Hibberd, MD PhD
• Email: plh0@bu.edu
• Phone: 617-358-2046

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) in Adults

  This study tests and compares the immune responses and tolerability of the latest COVID-19 vaccines from Novavax and Pfizer/BioNTech in adults at risk for severe COVID-19.

  Recruiting Phase 4 Henry M. Jackson Foundation for the Advancement of Military Medicine · Bethesda, Maryland · NCT07287137

• Evaluating treatments for severe community-acquired pneumonia in ICU patients

  This study tests different treatment options for ICU patients with severe pneumonia to see which ones work best, including special strategies for those with COVID-19.

  Recruiting at 234 sites Phase 3 UMC Utrecht · Jacksonville, Florida and 407 other locations · NCT02735707

• Virological Monitoring of Seasonal Respiratory Infections in France

  This project tests how often common respiratory viruses show up in patients seen by primary care doctors in metropolitan France during the fall and winter.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Paris · NCT07599449

• Remdesivir to prevent severe COVID-19 in kidney transplant patients

  This study will try giving remdesivir around the time of transplant to see if it prevents severe COVID-19 in adults receiving a kidney transplant who are currently SARS‑CoV‑2 positive with no or mild symptoms.

  Recruiting Phase 2 Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Badalona, Barcelona · NCT07197164

• Understanding how brain changes relate to smell disorders over time

  This small, year-long study tests how brain activity and smell-related inflammation relate to different smell disorders in adults.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07149428

• Monitoring and detection of influenza, RSV, and COVID-19 in adults with and without HIV in Lusaka

  This project will test methods to detect influenza, RSV, and COVID-19 in adults with and without HIV who have recent respiratory symptoms in Lusaka.

  Recruiting at 2 sites Centre for Infectious Disease Research in Zambia · Lusaka, Lusaka Province and 1 other locations · NCT07030075

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.