The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age as well as infants of age less than 90 days age.
Age range
18 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.
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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened.
Timeframe: During routine antenatal visits in the 4 months enrollment period (in antenatal clinics attached to study delivery units or the clinics serving the population delivering at those unit)
Proportion (percentage) of maternal subjects enrolled in ante-natal clinics.
Timeframe: During routine antenatal visits in the 4 months enrollment period(in antenatal clinics attached to study delivery units)
Proportion (percentage) of maternal subjects enrolled at delivery.
Timeframe: At delivery
Proportion (percentage) of mother-infant dyads enrolled with data available to assess early censorship criteria.
Timeframe: At delivery
Proportion (percentage) of enrolled mother-infant dyads with cord blood collected.
Timeframe: At delivery
Proportion (percentage) of enrolled mother-infant dyads with both maternal and cord blood collected.
Timeframe: At delivery
Proportion (percentage) of mother-infant dyads with complete data on the defined key clinical variables.
Timeframe: Throughout the study, an average of 4 months.
Percentage of subjects who completed the 90-day follow up visit in subset of subjects eligible for this visit.
Timeframe: At 90 day follow up visit
Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS.
Timeframe: Throughout the study, an average of 4 months.
Percentage of maternal subjects who had culture positive for GBS, classified by serotype.
Timeframe: Throughout the study, an average of 4 months.
GBS anti-capsular antibody concentration (serotype-specific anti capsular antibody) in maternal subjects, vaginally colonized with GBS.
Timeframe: At delivery
GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects.
Timeframe: At birth