No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Female
Study type
Observational
Participants needed
10,000 (estimated)
Sponsor
Boston University · Other
Who this trial is looking for
This trial is looking for pregnant women in their first trimester to study the effects of COVID-19 and influenza on pregnancy and newborn health. Participants will provide information about their health and undergo some tests at a hospital in Nagpur, India.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18 to 50 years.
I am registering for antenatal care at Government Medical College Hospital in Nagpur.
I am in the first trimester of my pregnancy (less than 14 weeks).
I plan to live in Nagpur throughout my pregnancy.
I am willing to be contacted twice a week for health screenings.
I will take my temperature and keep a symptom diary.
I can provide information about my pregnancy and newborn if care is outside the hospital.
I am willing to consent to join the study.
You may not be able to join if
I have a substantial impairment in cognitive functions.
I cannot provide legally effective consent to join a research study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other …
This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.
Trial Locations
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Eligibility 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 del…
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).
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