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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT03407157
Eligibility Criteria:
Inclusion Criteria:
* Pregnant with a singleton
* Gestational age between 23 and 25+0 weeks
* Over the age of 18
* Registered for delivery, at one of the participating centres
* Under the care of a regulated maternity care provider (midwife, obstetrician (OB), or family physician).
Exclusion Criteria:
* Unable to provide consent
* Fetus has known major anomalies
* Significant immunosuppression
* Type I or Type II diabetes (non-gestational)
* Previous infant with GBS (these women will automatically be advised to be treated with IV antibiotic therapy)
* GBS bacteriuria diagnosed in present pregnancy (reasoning as per above)
* Plans to use oral or vaginal probiotic supplementation/therapy (capsules/tablets/lozenges/drinks) during their pregnancy (outside of natural food sources; yogurt, kimchi, kombucha etc)
* Enrolled in another study that involves the administration of a drug/product
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03407157
Study Brief:
Protocol Section:
NCT03407157