Study on influenza and COVID-19 effects in pregnant women in India
Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India
This study is testing how getting both COVID-19 and influenza affects pregnant women and their babies, while also looking at how vaccinations might help reduce risks during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Boston University Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06168019 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 50 years who are registering for antenatal care at the Government Medical College Hospital in Nagpur and plan to remain in the area throughout their pregnancy.
Not a fit: Patients who are not planning to receive care at the Government Medical College Hospital or those who are beyond the first trimester of pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could inform guidelines on the vaccination of pregnant women against influenza and COVID-19, potentially improving maternal and neonatal health outcomes.
How similar studies have performed: Other studies have shown success in understanding the impact of respiratory viruses on pregnancy outcomes, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.