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Massive study tracks COVID-19 vaccine safety for 6,000 pregnant women and their babies

NCT ID NCT04705116

Knowledge-focused Sponsor: Pregistry Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 1 time

Summary

This study follows 6,000 pregnant women worldwide to compare health outcomes for those who received a COVID-19 vaccine during pregnancy versus those who did not. Researchers will track pregnancy complications, newborn health, and infant development up to 12 months old. The goal is to gather real-world data on vaccine safety, not to test a new treatment.

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

1,184 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 target study population consists of pregnant women who are 18 years of age and older. The exposed group (Cohort 1) includes pregnant women who received at least one dose of a COVID-19 vaccine from 30 days prior to the first day of the LMP to end of pregnancy. The reference group (Cohort 2) includes pregnant women who have not received a COVID-19 vaccine during pregnancy. Women vaccinated against COVID-19 before 30 days prior to the first day of the LMP are eligible in the reference group. Both cohorts will be matched by country of residence and gestational age at enrollment (±2 weeks).

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Vaccinated population: * Pregnant at time of enrollment * Age ≥18 years at time of enrollment * Signed the informed consent form and submitted the baseline module "COVID-19 Vaccination During This Pregnancy" * Received at least one dose of a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP * Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study Efforts will be made to obtain documentary evidence of COVID-19 vaccination. Comparison population: * Pregnant at time of enrollment * Age ≥18 years at time of enrollment * Signed the informed consent form and submitted the minimum required data in the initial baseline questionnaire * Have not received a COVID-19 vaccine during pregnancy or within the 30 days prior to the first day of the LMP * Resident of a country where a Central IRB or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study Exclusion criteria: * Not pregnant at time of enrollment * Age \<18 years at time of enrollment

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

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

COVID19

Contacts and locations

Locations

  • Pregistry

    Los Angeles, California, 90045, United States

More trials for these conditions

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