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

NCT ID: NCT03122704

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Preterm Labor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Group B Streptococcus (GBS) screening

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

Group Type: EXPERIMENTAL

GBS screening

Intervention Type: PROCEDURE

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

Interventions

GBS screening

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Manh Tuong Ho

OTHER

Sponsor Role: lead

Responsible Party

Manh Tuong Ho

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tuong M Ho, MD

Role: STUDY_DIRECTOR

Research Center for Genetics and Reproductive Health

Locations

My Duc Hospital

Ho Chi Minh City, Tan Binh District, Vietnam

Countries

Vietnam

Other Identifiers

NCKH/CGRH_09_2015

Identifier Type: -

Identifier Source: org_study_id