Time Frame for GBS Screening

NCT04116645 | Withdrawn

• 1 other identifier: 0251-19-RMB
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Sensitivity, specificity, positive and negative predictive values of GBS swabs in each week of gestation

  10 weeks fpr each woman

Study Arms (2)

Group 1

singleton pregnancies

Other: genital and rectal swab

Group 2

Twin pregnancies

Other: genital and rectal swab

Interventions

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.

Group 1; Group 2

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• Pregnant women that are being followed up prenatally or admitted at Rambam HealthCare Campus, Haifa, Israel and are planning to deliver there.
• Women at gestational age 300/7 or less.

You may not qualify if:

• Age 18 and under.
• Women with previous delivery of an infant affected by GBS disease.
• Women with known bacteriuria in the current pregnancy.
• Women whom are planning not to deliver at Rambam HealthCare Campus.
• Women who will not consent to participate in the study.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Dana Vitner, M.D

  vitnerdana@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: November 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2024
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share