None listed
Conditions
Brief summary
This study will test how accurately a new rapid test, StrepSure™, detects group B streptococcus (GBS) in pregnant women. GBS is a common bacteria that can be passed to babies during birth and sometimes cause serious illness. The current test takes up to two days, while StrepSure™ may give faster results at the point of care. Researchers will compare StrepSure™ to the standard test to see how reliable it is. The study will take place at Northern Hospital in Epping and involve women already receiving care there. The results of the StrepSure™ test will not be revealed to the participant or the clinical team. There will be no allocation to an intervention; therefore, this is not a clinical trial.
Interventions
This is a diagnostic accuracy study of a point of care device for group B streptococcus. The StrepSure™ test will be tested and compared to the gold standard culture method.
StrepSure Rapid GBS Test is a qualitative immunochromatographic assay that detects GBS antigens from a rectovaginal swab collected in the same manner as current GBS culture-based methods.
In this study, two rectovaginal swabs will be collected after informed consent. A standard GBS swab for culture will be taken first as
This is a diagnostic accuracy study of a point of care device for group B streptococcus. The StrepSure™ test will be tested and compared to the gold standard culture method. StrepSure Rapid GBS Test is a qualitative immunochromatographic assay that detects GBS antigens from a rectovaginal swab collected in the same manner as current GBS culture-based methods. In this study, two rectovaginal swabs will be collected after informed consent. A standard GBS swab for culture will be taken first as the gold standard, followed immediately by collection of a StrepSure swab sample using the same technique. There is no other active involvement of the participant after collection of the 2 samples. The samples will be collected at the time of admission for birth (either induction of labour, planned prelabour Cesarean section, early labour) or other hospital admission (eg for assessment of prelabour rupture of membranes, or threatened preterm labour). The samples will be collected by the research midwife or the treating clinician. If preferred, self-collection by the participant is an option as for current routine GBS screening. The StrepSure test will be analysed away from the bedside by the research midwife. It will take 30 minutes for a visual readout of the result. The results of the StrepSure test will not be revealed to the participant or the clinical team. The results of the control sample (GBS culture) will be revealed to the clinical team and be included in the electronic medical record. Only participants who enrol in the study will receive access to the StrepSure™ test.
Sponsors
The Northern Hospital - Epping
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each person must meet all of the following criteria to be enrolled in this study: 1. Is at least aged 18 years or older at the time of recruitment 2. Is pregnant with a live fetus 3. Presents to hospital for one of the following conditions: - Assessment for suspected spontaneous term or preterm labour - Assessment for suspected term or preterm prelabour rupture of membranes - Admission for removal of cervical cerclage - Admission for induction of labour (IOL) - Admission for elective Cesarean section (CS) - Antenatal inpatient admission for other indication 4. Provides a signed and dated informed consent form.
Exclusion criteria
Participants meeting any of the following criteria will be excluded from the study: 1. Has been diagnosed with a fetal death 2. Has a known hypersensitivity to Rayon or Nylon vaginal swab material 3. Has a high acuity medical/obstetric/mental health presentation that precludes adequate consent and participation, such as second stage of labour or placental abruption 4. Unable to provide informed consent in English, or with the assistance of an appropriate interpreter (a paid professional, not a family member).
Outcome results
None listed