CompletedNot Applicable

Tdap Vaccination During Pregnancy or Postpartum and Lactation-Related Outcomes

36,245 participantsStarted 2014-01

Plain-language summary

A retrospective cohort study based on the secondary use of pre-existing data. The study assesses the association between antenatal and postpartum maternal Tdap vaccination and select infant and lactation-related outcomes.

Who can participate

Age range

16 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infant growth - failure to thrive (Subgroup Pregnancy)

Timeframe: 3 months (91 days) to 12 months of age

Infant growth - failure to thrive (Subgroup Postpartum)

Timeframe: 3 months (91 days) to 12 months of age

Infant health care utilization - Number of infant outpatient visits up to 6 months of age (Subgroup Pregnancy)

Timeframe: 0 to 6 months after delivery

Infant health care utilization - Number of infant outpatient visits in the 90 days after index date (Subgroup Postpartum )

Timeframe: up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment

Infant health care utilization - Number of infant emergency department visits up to 6 months of age (Subgroup Pregnancy)

Timeframe: 0 to 6 months after delivery

Infant health care utilization - Number of infant emergency department visits in 90 days after index date (Subgroup Postpartum)

Timeframe: Up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment.

Trial details

NCT IDNCT07735767

SponsorHealthPartners Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Pertussis Vaccines trials

Who can participate

Age range

16 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Infant growth - failure to thrive (Subgroup Pregnancy)

Timeframe: 3 months (91 days) to 12 months of age

Infant growth - failure to thrive (Subgroup Postpartum)

Timeframe: 3 months (91 days) to 12 months of age

Infant health care utilization - Number of infant outpatient visits up to 6 months of age (Subgroup Pregnancy)

Timeframe: 0 to 6 months after delivery

Infant health care utilization - Number of infant outpatient visits in the 90 days after index date (Subgroup Postpartum )

Timeframe: up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment

Infant health care utilization - Number of infant emergency department visits up to 6 months of age (Subgroup Pregnancy)

Timeframe: 0 to 6 months after delivery

Infant health care utilization - Number of infant emergency department visits in 90 days after index date (Subgroup Postpartum)

Timeframe: Up to 6 months: 90-day window for vaccination plus 90-day window for outcome assessment.