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Could a routine pregnancy vaccine influence breastfeeding and baby health? a massive study digs into the data.

NCT ID NCT07735767

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This large study looks back at medical records of over 36,000 mother-infant pairs to see if receiving the Tdap vaccine during pregnancy or shortly after birth is linked to infant growth, how often babies need doctor or emergency visits, and whether mothers start or continue breastfeeding. The goal is to better understand any possible effects of the vaccine on these lactation-related outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tdap vaccine (tetanus, diphtheria, acellular pertussis)
What this could lead to
If clear patterns emerge, this could help guide vaccination timing to support infant health and breastfeeding success.
What could go wrong
This is an observational study using existing records, so it can show links but cannot prove cause and effect. Results may be influenced by other factors not accounted for.

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

36,245 people

The number who actually took part.

Started

Jan 2014

Finished

Dec 2022

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

Retrospective cohort study using existing automated electronic health record (EHR) data from two large integrated health care delivery systems based in Hawaii (Kaiser Permanente Hawaii) and Minnesota (HealthPartners).

Ages

16 to 49 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: The study includes pregnant women aged 16-49 years at delivery who had a live-birth delivery between 01 January 2014 (01 June 2018 for one site given data availability) and 31 December 2022, received prenatal care within the participating health systems before 6 months gestation, had a gestational age at delivery of at least 27 weeks, and linked to an infant with a WCV before 2 months of age within the participating health systems. Exclusion Criteria: We excluded those with Tdap vaccination before the recommended gestational age of 27 gestational weeks. For postpartum analyses, we excluded those who did not initiate human milk feeding or where human milk feeding information was not available.

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

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

More trials for these conditions

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