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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Labor

Intervention / Treatment
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* Procedure: GBS screening


Participation Criteria
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Eligibility Criteria
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* 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B Streptococcus (GBS) screening<br>Vaginal and anal swab of patients will be screened for GBS screening | Procedure: GBS screening<br>* Vaginal and anal swabs of patients will be screened for GBS screening<br>|

What is the study measuring?
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Primary Outcome Measures

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