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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

Egypt1 site
  • sahar M.Y elbaradie

    Al Fayyum

Other trials in Egypt

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.

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 groups in NCT04227730
Study groupRoleWhat they receive
group Agroup 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 Bgroup 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.

  1. prevalence of GBS in Fayoum

    Percentage of maternal GBS infection and its reflection on neonatal infection

    Measured: one year

Secondary outcomes (1)
  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.

  1. First posted14 Jan 2020
  2. Study start1 Jun 2019
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Why it stopped: COVID 19 Pandemic disabled team involved

Resources

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)
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

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.

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