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10,000 pregnant women join study to uncover virus risks

NCT ID NCT06168019

Knowledge-focused Sponsor: Boston University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 10,000 pregnant women in Nagpur, India, from early pregnancy through 42 days after birth. Researchers want to learn if catching flu or COVID-19 raises the risk of problems like preterm labor or severe pre-eclampsia. The goal is to provide clear evidence to help decide whether to vaccinate pregnant women against these viruses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population is pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India. Women will be aged 18-50 and can be from any race or ethnic group.

Ages

18 to 50 years

Sex

Female participants only

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

COVID-19 influenza perinatal disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19 Infant morbidity Influenza Other respiratory viruses Perinatal morbidity SARS-CoV-2 infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston University School of Public Health, Global Health

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Government. Medical College Hospital

    RECRUITING

    Nagpur, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.