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

Not Applicable

Withdrawn

• Conditions: Preterm Labor
• Interventions: Procedure: GBS screening

• Registration Number: NCT03122704
• Lead Sponsor: Manh Tuong Ho

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-21
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group B Streptococcus (GBS) screening	GBS screening	Vaginal and anal swab of patients will be screened for GBS screening

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

My Duc Hospital; 🇻🇳 Ho Chi Minh City, Tan Binh District, Vietnam