Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04227730 |
| Other study ID # |
FayoumEgypt |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
Fayoum University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 case-fatality ratios as high as 50%
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.
