Influenza + COVID-19 for Pregnancy Outcomes
(ICOPE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how having both the flu and COVID-19 during pregnancy affects the health of mothers and their babies. Researchers seek to determine if these infections lead to more complications during pregnancy and delivery. The study could inform decisions on whether pregnant women in India should receive vaccinations against these viruses. Women in their first trimester of pregnancy who plan to give birth at Government Medical College Hospital in Nagpur and can monitor their symptoms are ideal candidates for this study.
As an unphased trial, this study offers participants the chance to contribute to important research that could enhance maternal and infant health care in India.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that this study's exposures are safe for pregnant women?
Research shows that receiving the COVID-19 vaccine during pregnancy is generally safe for both mothers and their babies. Studies have not found an increased risk of negative pregnancy outcomes from the vaccine.
However, contracting COVID-19 while pregnant can be more concerning. Pregnant women who catch the virus may experience more severe symptoms than those who are not pregnant, posing risks for both the mother and the baby.
Regarding the flu, accurate information about when exposure occurs during pregnancy is crucial for understanding its safety. Although specific studies were not mentioned, this underscores the need for careful monitoring of flu exposure during pregnancy.
In summary, COVID-19 vaccines have been safe for pregnant women, but contracting the virus can be more worrisome. More precise tracking of flu exposure during pregnancy is needed to ensure safety.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's diving into how influenza and COVID-19 affect pregnant women and their babies in India. Unlike traditional studies that might focus on treatment options, this research is all about understanding the unique challenges and impacts these viruses have during pregnancy. By gathering data from pregnant women in their first trimester, the study aims to uncover insights into the epidemiology of these infections. This could lead to better prevention strategies and care protocols tailored specifically for this vulnerable group.
What evidence suggests that this trial's treatments could be effective for improving pregnancy outcomes?
Research has shown that contracting COVID-19 during pregnancy can lead to problems for both mothers and babies. Pregnant women with COVID-19 face a higher risk of serious health issues. Similarly, contracting the flu while pregnant can cause pregnancy loss and other complications. Vaccination against both COVID-19 and the flu has proven to be safe and helps lower these risks. This trial will examine the effects of influenza and COVID-19 on pregnancy outcomes, supporting the idea that avoiding these infections benefits pregnancy health.34678
Who Is on the Research Team?
Patricia Hibberd, MD PhD
Principal Investigator
Boston University School of Public Health, Global Health
Archana Patel, MD
Principal Investigator
Lata Medical Research Foundation, Nagpur India
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Visit
Enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy
Observational Period
Participants receive standard of care throughout pregnancy, labor, delivery, and postpartum to discharge. Study visits coincide with regular antenatal care and include additional blood draws.
Follow-up
Participants are monitored for safety and effectiveness after delivery, including monitoring for adverse maternal and perinatal outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Exposures
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston University
Lead Sponsor
Lata Medical Research Foundation, Nagpur
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Pregnancy loss <28 weeks gestation in maternal influenza ...
We aimed to identify and evaluate data sources and data collection methods currently used to capture pregnancy losses <28 weeks following maternal influenza ...
Neonatal and maternal outcomes following SARS-CoV-2 ...
These data suggest SARS-CoV-2 infection during pregnancy is associated with adverse neonatal and maternal outcomes, and COVID-19 vaccination remains a safe way ...
3.
journals.lww.com
journals.lww.com/greenjournal/fulltext/9900/maternal_and_neonatal_outcomes_after_respiratory.1404.aspxMaternal and Neonatal Outcomes After Respiratory ...
Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy. Nat Commun 2022;13 ...
4.
mayoclinic.org
mayoclinic.org/diseases-conditions/coronavirus/in-depth/pregnancy-and-covid-19/art-20482639Pregnancy and COVID-19: What are the risks?
Pregnancy is a factor that raises the risk of severe COVID-19. That risk stays higher for at least a month after giving birth.
COVID-19 FAQs for Obstetrician-Gynecologists, Obstetrics
Yes. The CDC reports pregnancy and recent pregnancy as conditions with conclusive evidence indicating an increased risk for at least one severe outcome from ...
Obstetric Complications and Birth Outcomes After ...
Studies to date have not identified an increased risk of adverse pregnancy outcomes associated with antenatal COVID-19 vaccination.
In Utero Exposure to Maternal COVID-19 and Offspring ...
The research highlights the potential impacts of maternal COVID-19 infection on early neurodevelopmental outcomes in children.
Underlying Conditions and the Higher Risk for Severe ...
Age remains the strongest risk factor for severe COVID-19 outcomes, with risk of severe outcomes increasing markedly with increasing age.
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