Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis

NCT02143154 | Completed

• 1 other identifier: Vancomycin for Group B Strept
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

While it is clear that intrapartum antibiotics reduce neonatal GBS infection rates, the mechanism by which these drugs prevent neonatal GBS is not well established. One postulated theory is antibiotics work to reduce bacterial load in the birth canal; thus decreasing fetal exposure during labor and delivery. To our knowledge, the relationship between vancomycin and vaginal GBS colony counts has never been studied. In this prospective cohort study, our objective is to determine the relationship between intrapartum IV vancomycin and vaginal GBS colony counts.

Conditions

GBS Positive; Women in Labor Given Vancomycin for Prophylaxis

Keywords

vancomycin, GBS

Outcome Measures

Primary Outcomes (1)

• Percentage decline in vaginal GBS colony counts

  up to eight hours or delivery

Study Arms (1)

GBS positive women

Women wih GBS positive bacteruria with plan for treatment with vancomycin in labor, or women with positive GBS screening cultures with a plan to receive vancomycin in labor

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis

You may qualify if:

• Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis,
• ability to give informed consent,
• aged 18-48,
• English and or Spanish speaking, admitted in labor or undergoing induction of labor

You may not qualify if:

• Inability to give consent,
• currently receiving antibiotics for another indication,
• recent antibiotic use (within the previous 7 days),
• allergy to vancomycin

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Biospecimen

Retention: NONE RETAINED

vaginal swabs collected during labor plated for GGBS bacteria and then discarded

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maureen S Hamel, MD

  Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: October 1, 2014
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Locations

US (1)