MATERNAL AND NEONATAL SCREENING FOR GROUP B STREPTOCOCCI : A Follow up STUDY

NCT04227730 | Withdrawn

• 1 other identifier: FayoumEgypt
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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%

Conditions

Group B Streptococcal Infection

Outcome Measures

Primary Outcomes (1)

• prevalence of GBS in Fayoum

  Percentage of maternal GBS infection and its reflection on neonatal infection

  one year

Secondary Outcomes (1)

• improve and simplify the diagnosis of GBS

  one year

Study Arms (2)

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.

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.

Diagnostic Test: culture and PCR for group B streptococcus

Interventions

culture and PCR for group B streptococcus DIAGNOSTIC_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.

group A; group B

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• pregnant females 35-37 weeks of gestational age Patients who were followed till delivery without prolonged rupture of membrane

You may not qualify if:

• patients lost follow up and or had prolonged rupture of membrane\>12 hours

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

sahar M.Y elbaradie

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate Professor

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: June 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

EG (1)