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Time Frame for GBS Screening

NCT04116645 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-01-13

No results posted yet for this study

Summary

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.

Conditions

  • GBS
  • Group B Streptococcal Infection

Interventions

OTHER

genital and rectal swab

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.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-10-30
Completion
2024-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116645 on ClinicalTrials.gov