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

April 17, 2017 updated by: Manh Tuong Ho

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Tan Binh District
      • Ho Chi Minh City, Tan Binh District, Vietnam, 70000
        • My Duc Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

* 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manh Tuong Ho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCKH/CGRH_09_2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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