GBS PositiveNCT02143154
Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis
An observational study of GBS Positive and Women in Labor Given Vancomycin for Prophylaxis, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GBS Positive, Women in Labor Given Vancomycin for Prophylaxis
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 3 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- Inability to give consent,
- currently receiving antibiotics for another indication,
- recent antibiotic use (within the previous 7 days),
- allergy to vancomycin
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Intrapartum Vancomycin in GBS-positive Women: The Effect on Vaginal Group B Streptococcus Colony Counts
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.
Read the detailed description
Charts of patients presenting for induction of labor will be reviewed for potential eligibility. After provider permission, eligible patients will be approached for screening who are presenting for induction with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis. Patients presenting to the emergency room for labor evaluation/labor evaluation/pre-term labor evaluation, may be pre-screened for potential eligibility. Patients subsequently admitted in labor/preterm labor or with rupture of membranes with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis will be approached for screening. Additionally pharmacy will alert study staff when a patient is admitted to the labor floor or antenatal care unit and vancomycin has been ordered for antibiotic prophylaxis. These patients will then be approached for screening
Data collection: Demographic information such as age, race, date of initial GBS culture and time of rupture of membranes will be abstracted from enrolled patients' charts. Intrapartum vaginal cultures will be collected with a vaginal swab from the distal vagina by trained obstetrics and gynecology residents, attendings, nurses, nurse midwives and nurse practitioners prior to the initiation of antibiotics and at two hour intervals until delivery or after eight hours has elapsed.
Swabs will be transported to the lab. Colony counts will be determined via serial dilution. Specimens will be diluted in sterile saline and inoculated onto Columbia Agar containing 5% sheep blood, colistin (10 mg), and nalidixic acid (10 mg/L). After incubation for 48 hours at 35 C in ambient air, the number of colonies on the dilution plates will be visually counted and multiplied by the appropriate dilution factor for that particular plate.
- Keywords
- vancomycin, GBS
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage decline in vaginal GBS colony counts
Measured: up to eight hours or delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startOct 2014
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBS PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maureen S Hamel, MD, Principal investigator, Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143154
- Sponsor's protocol ID
- Vancomycin for Group B Strept
- Status last verified
- Oct 2018
- First submitted
- 16 May 2014
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Vancomycin in GBS-positive Women: The Effect on Vaginal Group B Streptococcus Colony Counts
- ClinicalTrials.gov ID
- NCT02143154
- Acronym / sponsor ID
- Vancomycin for Group B Strept
- Keywords
- vancomycin, GBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Charts of patients presenting for induction of labor will be reviewed for potential eligibility. After provider permission, eligible patients will be approached for screening who are presenting for induction with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis. Patients presenting to the emergency room for labor evaluation/labor evaluation/pre-term labor evaluation, may be pre-screened for potential eligibility. Patients subsequently admitted in labor/preterm labor or with rupture of membranes with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis will be approached for screening. Additionally pharmacy will alert study staff when a patient is admitted to the labor floor or antenatal care unit and vancomycin has been ordered for antibiotic prophylaxis. These patients will then be approached for screening
Data collection: Demographic information such as age, race, date of initial GBS culture and time of rupture of membranes will be abstracted from enrolled patients' charts. Intrapartum vaginal cultures will be collected with a vaginal swab from the distal vagina by trained obstetrics and gynecology residents, attendings, nurses, nurse midwives and nurse practitioners prior to the initiation of antibiotics and at two hour intervals until delivery or after eight hours has elapsed.
Swabs will be transported to the lab. Colony counts will be determined via serial dilution. Specimens will be diluted in sterile saline and inoculated onto Columbia Agar containing 5% sheep blood, colistin (10 mg), and nalidixic acid (10 mg/L). After incubation for 48 hours at 35 C in ambient air, the number of colonies on the dilution plates will be visually counted and multiplied by the appropriate dilution factor for that particular plate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to give consent,
- currently receiving antibiotics for another indication,
- recent antibiotic use (within the previous 7 days),
- allergy to vancomycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage decline in vaginal GBS colony counts
Time frame: up to eight hours or delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for GBS Positive
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Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
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Group B Streptococcus Infection and PROM Incidince
Premature Rupture of Fetal Membranes, Group B Streptococcal Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen S Hamel, MD principal investigator
Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GBS Positive and Women in Labor Given Vancomycin for Prophylaxis, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage decline in vaginal GBS colony counts (time frame: up to eight hours or delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.