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This study would not add any new information
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All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study. If a patient is agreeable, the nurse/physician/research coordinator will obtain informed consent.
Once informed consent is obtained, the patient can be swabbed for GBS. The swabs will be obtained at the routine follow-up at the clinic at 30, 32 and 35 weeks' gestation.
If a patient is found to have a positive GBS culture at 35 weeks, she will receive antibiotic treatment during labour according to the protocol.
GBS swabs taken at delivery will be compared to previous swabs taken at an earlier gestational age in order to evaluate sensitivity, specificity, positive and negative predictive values of GBS swabs at each week of gestation and to determine the value of our primary hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | singleton pregnancies |
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| Group 2 | Twin pregnancies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genital and rectal swab | Other | 6. Swabs for GBS culture should be obtained, ideally before digital examination or use of lubricants, from both the lower vagina (vaginal introitus) and rectum (insert swab through the anal sphincter) to achieve maximum sensitivity. Either two swabs (one for each site) or a single swab can be used; one swab is more cost saving. The swabs will be obtained by the patient herself after appropriate instruction or by the provider healthcare, as studies have shown equivalent sensitivity between the healthcare provider and the patient herself. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the best timing for GBS screening. | When is the best time to swab for GBS and what is the percentage of women with the same swab results at 30 or 32 weeks' gestation and at delivery | 10 weeks for each woman from the first swab to the last (at delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, positive and negative predictive values of GBS swabs in each week of gestation | 10 weeks fpr each woman |
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Inclusion Criteria:
Exclusion Criteria:
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We plan to conduct an open label prospective trial of all women with a singleton pregnancy which will be screened for GBS in four different time-points during their pregnancy, from 30 weeks' gestation up to delivery - 30, 32, 35 weeks' gestational age and at delivery.
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| Name | Affiliation | Role |
|---|---|---|
| Dana Vitner, M.D | vitnerdana@gmail.com | Principal Investigator |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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