Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-22 @ 9:27 AM
Study NCT ID:
NCT03122704
Status:
WITHDRAWN
Last Update Posted:
2017-04-21
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
Sponsor:
Manh Tuong Ho
Organization:
Study Overview
Official Title:
Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a cross - sectional study to determine the prevalence of GBS infection and associated factors in preterm labor women conceived through ART.
221 subjects will be involved.
221 subjects will be involved.
Detailed Description:
Pregnant women at 20 0/7 to 36 6/7 weeks of gestation, conceived through ART, with signs and symptoms of preterm labor will be recruited.
Anal - vaginal fluid samples will be taken by 2 cotton swabs from each participant for culture. Digital examination will be performed after that. Only participants fulfilling all the study's eligible criteria will be interviewed face-to-face with a questionnaire.
The samples will be sent immediately to My Duc hospital laboratory or will be stored in Stuart-Amies medium in \< 4 hours. All culture results are interpreted based on Clinical and Laboratory Standards Institute (CLSI) in 2012.
Statistical analysis was performed by Statistical Package for the Social Sciences (SPSS) v.20 and chi-square test. A p-value of \< 0.05 was considered as statistically significant.
Anal - vaginal fluid samples will be taken by 2 cotton swabs from each participant for culture. Digital examination will be performed after that. Only participants fulfilling all the study's eligible criteria will be interviewed face-to-face with a questionnaire.
The samples will be sent immediately to My Duc hospital laboratory or will be stored in Stuart-Amies medium in \< 4 hours. All culture results are interpreted based on Clinical and Laboratory Standards Institute (CLSI) in 2012.
Statistical analysis was performed by Statistical Package for the Social Sciences (SPSS) v.20 and chi-square test. A p-value of \< 0.05 was considered as statistically significant.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: