The Implementation of Real-time PCR - Intrapartum GBS (Group B Streptococcus) Colonization to Reduce Antibiotic Prophylaxis

NCT03936816 | Completed

• 1 other identifier: CMC-19-0027-CTIL
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

The implementation of real-time PCR for detection of intrapartum GBS (group B Streptococcus) colonization as a way to reduce antibiotic prophylaxis usage.

Conditions

GBS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• validity of GBS PCR

  The patients will be assessed once upon admission to labor room by having a double vaginal swab for GBS PCR and GBS culture

Study Arms (2)

GBS screened positive

150 patients that were screened positive by culture at 35-37 weeks gestational age.

Other: GBS vaginal double swab

GBS unknown with risk factors

150 patients that were not screened for GBS and have risk factors for GBS prophylaxis.

Other: GBS vaginal double swab

Interventions

GBS vaginal double swab OTHER

The vaginal double swab will be assessed by two different lab tests: The first one for GBS culture on selective media after enrichment of 16h and the second swab by the Cepheid Xpert GBS Assay performed on the GeneXpert Dx system which is a qualitative in vitro diagnostic test designed to detect GBS DNA from vaginal swab specimens, using fully automated real-time polymerase chain reaction (PCR).

GBS screened positive; GBS unknown with risk factors

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of 300 patient admitted to the labor ward in CARMEL medical center that need prophylactic antibiotics for GBS because of culture screen at 35-37 weeks or because of having risk factors.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Carmel Medical Center: lead
• Cepheid: collaborator

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 3, 2019
• Study Start: June 1, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 30, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)