Last reviewed · How we verify

NCT04116645

Time Frame for GBS Screening

Withdrawn Last updated 13 January 2022
What this trial tests

trial testing genital and rectal swab in GBS. Withdrawn.

Timeline
1 November 2020
Primary endpoint
30 October 2022
30 October 2024

Quick facts

Lead sponsorRambam Health Care Campus
StatusWithdrawn
Study typeOBSERVATIONAL
Start date1 November 2020
Primary completion30 October 2022
Estimated completion30 October 2024

Drugs / interventions tested

Conditions studied

Sponsor

Rambam Health Care Campus — full company profile →

Who can join

Adults 18 to 45, female only, with GBS or Group B Streptococcal Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for GBS

Currently open trials in the same condition.

Other Rambam Health Care Campus trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04116645.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing