Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF

Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03122704

Enrollment

Registered

2017-04-21

Start date

2015-10-31

Completion date

2016-09-30

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor

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.

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.

Interventions

PROCEDUREGBS screening

Vaginal and anal swabs of patients will be screened for GBS screening

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

\* Inclusion Criteria: To be eligible for enrolment into this trial, subject must fulfil all of the following criteria, unless specified otherwise * Being conceived through IVF * Moderate uterine contractions (2 contractions per 10 minutes, duration \< 30 seconds) * 20 0/7 to 36 6/7 weeks of gestation * Intact membrane * Cervical dilation ≤ 3 cm * Willing to participate into the study *

Exclusion criteria

To be eligible for enrolment in this study each subject must not meet any of the following criteria: * Having had intercourse during 24 hours before * Being suspected of amniotic leakage * Rupture of membrane identified by direct observation through speculum examination of amniotic fluid flow from cervix * Vaginal bleeding * Being suspected of placenta abruption, placenta previa * Having been treated with antibiotics within 1 week before * Vaginal douche within 48 hours before * Having used vaginal medicines during 48 hours before * Having vaginal ultrasound shortly before * Urine culture positive with GBS

Design outcomes

Primary

Measure	Time frame	Description
Percentage of women with GBS infection	7 days after swab taken	Number of women with GBS infection divided by total number of women under screening

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026