Group B Streptococcal InfectionNCT04227730
MATERNAL AND NEONATAL SCREENING FOR GROUP B STREPTOCOCCI : A Follow up STUDY
An observational study of Group B Streptococcal Infection, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938. In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and… Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Group B Streptococcal Infection
- What is being tested?
- culture and PCR for group B streptococcus
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 31 Dec 2020
- 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 46 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant females 35-37 weeks of gestational age attending the antenatal outpatient clinic at AlFayom University Hospital. All participants were screened by a group B streptococcal (GBS) conventional PCR assay. Patients who were followed till delivery without prolonged rupture of membrane were eligible to enter the study and details with regard to labor and delivery were recorded delivery was conducted at AlFayom university hospital. Infant data were also recorded.
Who may be able to join
- pregnant females 35-37 weeks of gestational age Patients who were followed till delivery without prolonged rupture of membrane
Who cannot join
- patients lost follow up and or had prolonged rupture of membrane>12 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal And Neonatal Screening For Group B Streptococci in Fayoum Governrate: A Follow Up Study
Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938. In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and case-fatality ratios as high as 50%
Read the detailed description
Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938 (1). In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and case-fatality ratios as high as 50% (2). It causes severe invasive infection in newborns 80% of which occur within the first week of life (early-onset neonatal sepsis) that results from ascending spread of GBS into the amniotic fluid through both ruptured and intact membranes (3,4). Infants who have such infections may require prolonged hospitalization, and those who survive may have mental retardation or visual loss (5).
Transmission from mother to child has been reported to be 29 times higher in GBS-colonized mothers than in noncolonized mothers. The prevalence of GBS colonization in the vagina and/or rectum among pregnant women can vary among ethnic groups and geographical locations, ranging from approximately 10% to 40% (6). Although GBS colonization is not associated with disease in healthy women, colonization in pregnant women may be associated with urinary tract infection, bacteremia, amnionitis, endometritis, postpartum wound infections, and rarely, meningitis (7).
A number of obstetric factors have been associated with an increased likelihood of early-onset GBS disease in the newborn. These include maternal colonization of the vagina and rectum with GBS, preterm birth, prolonged rupture of membranes, intrapartum fever, women younger than 20 years (8), women with prior GBS-infected infant, women with heavy colonization- GBS bacteriuria equal to or greater than 104 colony forming units or low levels of anti-GBS capsular antibody(9,10).
Intrapartum antibiotic prophylaxis (IAP) has been shown not only to interrupt the transmission of GBS from mother to infant but also to reduce the incidence of early-onset GBS disease (11). Guidelines from the Federal Centers for Disease Control and Prevention (CDC) (12), the American College of Obstetricians and Gynecologists (ACOG) (6) and the American Academy of Pediatrics (AAP) issued in 1996 and 2002(13, 14) recommended two different strategies for the selection of candidates for IAP: either screening for GBS vaginorectal carriers or identification of maternal clinical risk factors for early-onset neonatal GBS disease. They recommended obtaining rectovaginal cultures at 35-37 weeks of gestation with the culture-based approach (12).
The value and practicality of both strategies has been debated in the literature. At issue is potential overtreatment (in the case of the culture strategy) and under treatment (in the case of the risk-factor strategy) of patients, as well as the associated cost. For example, the standard screening test, a rectovaginal culture taken at 35 to 37 weeks, has been controversial because it may not accurately predict genital tract colonization at time of labor (with an estimated sensitivity of 87%-91% and specificity of 89%-96%). The risk-factor method, on the other hand, would target treatment toward the mothers believed to be at greatest risk but would miss many colonized mothers and at-risk infants (15, 16). Despite their limitations, both approaches are effective in reducing early-onset group B streptococcal infection rate in infants, although more widespread implementation of the guidelines is needed (11, 17).
The Committee on Obstetric Practice 2003 recognized that compliance with the culture-based approach will require the implementation of several steps (18)
- Obtaining accurate culture media
- Appropriate processing of the culture by laboratories
- Timely reporting of results to obstetric providers
- Administering intrapartum prophylaxis to culture-positive women
The sensitivity of cultures in detecting GBS colonization varies from 54% to 87%, and results has a slow turnaround time requiring up to 36 to 72 hours before results can be issued(3,16). Besides being time-consuming, this method requires an experienced technician to identify the suspected colonies, which are not always beta-hemolytic. Moreover, the suppression of GBS growth by enterococci present in the vaginal and rectal flora could lead to false-negative results (19).
Rapid methods of detection of GBS colonization in pregnant women namely molecular biology based assays have become the focus of investigation in recent years. The most promising of these techniques is the polymerase chain reaction (PCR), which is reported to be highly sensitive and specific among women in labor and to yield results in 30 to 45 minutes (20).
The rate of GBS colonization and disease among pregnant women and their infants has not been studied in Egypt, and no preventive strategy has been formulated with regard to intrapartum antimicrobial prophylaxis.
- Conditions
- Group B Streptococcal Infection
- Being tested
- culture and PCR for group B streptococcus
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture and PCR for group B streptococcusDiagnostic test
all participants were evaluated by vaginorectal specimens for the detection of GBS, The swabs are placed in Amies transport medium and sent to the microbiology laboratory for testing by conventional PCR assay.
| Study group | Role | What they receive |
|---|---|---|
| group A | group A (+ve GBS) 300 pregnant of gestational age 35-37 weeks were screened by a group B streptococcal (GBS) conventional PCR assay. Patients who were followed till delivery without prolonged rupture of membrane were eligible to enter the study and details with regard to labor and delivery were recorded. Infant data were also recorded. Receives: Diagnostic Test: culture and PCR for group B streptococcus | |
| group B | group B (-ve GBS) 300 pregnant of gestational age 35-37 weeks were screened by a group B streptococcal (GBS) conventional PCR assay. Patients who were followed till delivery without prolonged rupture of membrane were eligible to enter the study and details with regard to labor and delivery were recorded. Infant data were also recorded. Receives: Diagnostic Test: culture and PCR for group B streptococcus |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of GBS in Fayoum
Percentage of maternal GBS infection and its reflection on neonatal infection
Measured: one year
Secondary outcomes (1)
improve and simplify the diagnosis of GBS
Rapid methods of detection of GBS colonization (molecular biology based assay) the polymerase chain reaction (PCR),
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jun 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: COVID 19 Pandemic disabled team involved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B Streptococcal InfectionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar MY Elbaradie, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227730
- Sponsor's protocol ID
- FayoumEgypt
- Status last verified
- Mar 2022
- First submitted
- 10 Jan 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal And Neonatal Screening For Group B Streptococci in Fayoum Governrate: A Follow Up Study
- ClinicalTrials.gov ID
- NCT04227730
- Acronym / sponsor ID
- FayoumEgypt
- Conditions
- Group B Streptococcal Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID 19 Pandemic disabled team involved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jan 2020 (actual)
- 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.
Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938. In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and case-fatality ratios as high as 50%
Detailed description
Group B Streptococcus (GBS), is a facultative gram positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938 (1). In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality, with a frequency of 2-3 cases per 1,000 live births and case-fatality ratios as high as 50% (2). It causes severe invasive infection in newborns 80% of which occur within the first week of life (early-onset neonatal sepsis) that results from ascending spread of GBS into the amniotic fluid through both ruptured and intact membranes (3,4). Infants who have such infections may require prolonged hospitalization, and those who survive may have mental retardation or visual loss (5).
Transmission from mother to child has been reported to be 29 times higher in GBS-colonized mothers than in noncolonized mothers. The prevalence of GBS colonization in the vagina and/or rectum among pregnant women can vary among ethnic groups and geographical locations, ranging from approximately 10% to 40% (6). Although GBS colonization is not associated with disease in healthy women, colonization in pregnant women may be associated with urinary tract infection, bacteremia, amnionitis, endometritis, postpartum wound infections, and rarely, meningitis (7).
A number of obstetric factors have been associated with an increased likelihood of early-onset GBS disease in the newborn. These include maternal colonization of the vagina and rectum with GBS, preterm birth, prolonged rupture of membranes, intrapartum fever, women younger than 20 years (8), women with prior GBS-infected infant, women with heavy colonization- GBS bacteriuria equal to or greater than 104 colony forming units or low levels of anti-GBS capsular antibody(9,10).
Intrapartum antibiotic prophylaxis (IAP) has been shown not only to interrupt the transmission of GBS from mother to infant but also to reduce the incidence of early-onset GBS disease (11). Guidelines from the Federal Centers for Disease Control and Prevention (CDC) (12), the American College of Obstetricians and Gynecologists (ACOG) (6) and the American Academy of Pediatrics (AAP) issued in 1996 and 2002(13, 14) recommended two different strategies for the selection of candidates for IAP: either screening for GBS vaginorectal carriers or identification of maternal clinical risk factors for early-onset neonatal GBS disease. They recommended obtaining rectovaginal cultures at 35-37 weeks of gestation with the culture-based approach (12).
The value and practicality of both strategies has been debated in the literature. At issue is potential overtreatment (in the case of the culture strategy) and under treatment (in the case of the risk-factor strategy) of patients, as well as the associated cost. For example, the standard screening test, a rectovaginal culture taken at 35 to 37 weeks, has been controversial because it may not accurately predict genital tract colonization at time of labor (with an estimated sensitivity of 87%-91% and specificity of 89%-96%). The risk-factor method, on the other hand, would target treatment toward the mothers believed to be at greatest risk but would miss many colonized mothers and at-risk infants (15, 16). Despite their limitations, both approaches are effective in reducing early-onset group B streptococcal infection rate in infants, although more widespread implementation of the guidelines is needed (11, 17).
The Committee on Obstetric Practice 2003 recognized that compliance with the culture-based approach will require the implementation of several steps (18)
- Obtaining accurate culture media
- Appropriate processing of the culture by laboratories
- Timely reporting of results to obstetric providers
- Administering intrapartum prophylaxis to culture-positive women
The sensitivity of cultures in detecting GBS colonization varies from 54% to 87%, and results has a slow turnaround time requiring up to 36 to 72 hours before results can be issued(3,16). Besides being time-consuming, this method requires an experienced technician to identify the suspected colonies, which are not always beta-hemolytic. Moreover, the suppression of GBS growth by enterococci present in the vaginal and rectal flora could lead to false-negative results (19).
Rapid methods of detection of GBS colonization in pregnant women namely molecular biology based assays have become the focus of investigation in recent years. The most promising of these techniques is the polymerase chain reaction (PCR), which is reported to be highly sensitive and specific among women in labor and to yield results in 30 to 45 minutes (20).
The rate of GBS colonization and disease among pregnant women and their infants has not been studied in Egypt, and no preventive strategy has been formulated with regard to intrapartum antimicrobial prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Diagnostic Test: culture and PCR for group B streptococcusgroup A (+ve GBS) 300 pregnant of gestational age 35-37 weeks were screened by a group B streptococcal (GBS) conventional PCR assay. Patients who were followed till delivery without prolonged rupture of membrane were eligible to enter the study and details with regard to labor and delivery were recorded. Infant data were also recorded. |
| group B | – | Diagnostic Test: culture and PCR for group B streptococcusgroup B (-ve GBS) 300 pregnant of gestational age 35-37 weeks were screened by a group B streptococcal (GBS) conventional PCR assay. Patients who were followed till delivery without prolonged rupture of membrane were eligible to enter the study and details with regard to labor and delivery were recorded. Infant data were also recorded. |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant females 35-37 weeks of gestational age attending the antenatal outpatient clinic at AlFayom University Hospital. All participants were screened by a group B streptococcal (GBS) conventional PCR assay. Patients who were followed till delivery without prolonged rupture of membrane were eligible to enter the study and details with regard to labor and delivery were recorded delivery was conducted at AlFayom university hospital. Infant data were also recorded.
Key inclusion criteria (1 listed)
- pregnant females 35-37 weeks of gestational age Patients who were followed till delivery without prolonged rupture of membrane
Key exclusion criteria (1 listed)
- patients lost follow up and or had prolonged rupture of membrane>12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| culture and PCR for group B streptococcusall participants were evaluated by vaginorectal specimens for the detection of GBS, The swabs are placed in Amies transport medium and sent to the microbiology laboratory for testing by conventional PCR assay. | Diagnostic test | group A, group B |
Primary outcome
prevalence of GBS in Fayoum
Time frame: one year
Percentage of maternal GBS infection and its reflection on neonatal infection
1 secondary outcome
improve and simplify the diagnosis of GBS
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Group B Streptococcal Infection, run by Fayoum University Hospital at 1 site in Egypt.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 31 Mar 2022. 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 Egypt. 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 was withdrawn before enrolling participants, so there are no results.
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?
prevalence of GBS in Fayoum (time frame: one year). 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 31 Mar 2022.