Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT06258057
Eligibility Criteria:
Inclusion Criteria:
* For pregnant individuals:
* Continuous enrollment, with no more than a 1-month administrative gap from 90 days prior to their last menstrual period (LMP)
* Continuous enrollment for the duration of their pregnancy through delivery or termination of pregnancy (or 6 weeks postpartum for preeclampsia/eclampsia and 28 days for PPH) unless censored at death in order to capture study outcomes
* At least 1 prenatal visit prior to 27 weeks of gestation during pregnancy
* For offspring:
* Infants delivered by pregnant individuals who meet all the inclusion criteria above
* With gestational age as calculated based on date of birth recorded in the EMR
Exclusion Criteria:
* For pregnant individuals:
* Loss of pregnancy or with delivery before 27 weeks of gestation
* Vaccinated with Boostrix® (Tdap vaccine, GSK), or with an unknown brand of Tdap vaccine, or Td (tetanus, diphtheria) vaccine during pregnancy
* Vaccinated with any Tdap vaccine prior to the ACIP recommended optimal timeframe of ≥ 270/7 weeks of gestation
* Received more than one Tdap vaccine during pregnancy
* Vaccinated with one or more live vaccines during pregnancy
* Pregnant individuals with multiple gestation pregnancies (eg, twins, triplets)
* For offspring:
* Infants delivered by pregnant individuals who meet any of the exclusion criteria above
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
49 Years
Study:
NCT06258057
Study Brief:
Protocol Section:
NCT06258057