GBS Clinical Trial
Official title:
The Implementation of Real-time PCR for Detection of Intrapartum GBS (Group B Streptococcus) Colonization as a Way to Reduce Antibiotic Prophylaxis Usage
Verified date | September 2020 |
Source | Carmel Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The implementation of real-time PCR for detection of intrapartum GBS (group B Streptococcus) colonization as a way to reduce antibiotic prophylaxis usage.
Status | Completed |
Enrollment | 303 |
Est. completion date | August 30, 2020 |
Est. primary completion date | August 15, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
inclusion criteria: - Pregnant patients that were screened positive by a culture at 35-37 weeks (those patients will be screened with a vaginal double swab upon admission to labor ward). - Pregnant patients with GBS bacteriuria in current pregnancy (those patients will be screened with a vaginal double swab upon admission to labor ward). - Pregnant patients in preterm labor before 37 weeks (those patients will be screened with a vaginal double swab upon admission to labor ward). - Pregnant patients with prolonged rupture of membranes (those patients will be screened with a vaginal double swab after 17 hours and prior to antibiotics treatment). - All patients have signed an informed consent. Exclusion Criteria: - Pregnant patients that do not want to participate in the study. - Pregnant patients that fever is the risk factor for GBS prophylaxis. - Pregnant patients that were screened negative by a culture at 35-37 weeks. - Pregnant patient with PPROM (before 34 weeks). |
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Carmel Medical Center | Cepheid |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intrapartum GBS PCR in patients that require GBS prophylaxis | The investigators intend to compare the number of patients that require GBS prophylaxis because they were screened positive (at 35-37 weeks) or have risk factors during labor (300 patients) to the number of patients that will be found positive on real time PCR upon admission to labor room. In that way the reduction (in percentage) for the need of GBS prophylaxis will be assessed. | The patients will be assessed once upon admission to labor room by having a double vaginal swab for GBS PCR and GBS culture | |
Secondary | validity of GBS PCR | Each patient that will be recruited will be sampled vaginally by a double swab for PCR and culture for GBS. The investigators intend to compare the number positive results of PCR GBS to the number of positive culture results (which is considered gold standard) and in that way to determine the sensitivity and specificity of PCR for GBS. | The patients will be assessed once upon admission to labor room by having a double vaginal swab for GBS PCR and GBS culture |
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