Back to resultsGroup B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
Primary Purpose
Preterm Labor
Status
Withdrawn
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
GBS screening
Sponsored by
About this trial
This is an interventional screening trial for Preterm Labor
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
Sites / Locations
- My Duc Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group B Streptococcus (GBS) screening
Arm Description
Vaginal and anal swab of patients will be screened for GBS screening
Outcomes
Primary Outcome Measures
Percentage of women with GBS infection
Number of women with GBS infection divided by total number of women under screening
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03122704
Brief Title
Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
Official Title
Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manh Tuong Ho
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B Streptococcus (GBS) screening
Arm Type
Experimental
Arm Description
Vaginal and anal swab of patients will be screened for GBS screening
Intervention Type
Procedure
Intervention Name(s)
GBS screening
Intervention Description
Vaginal and anal swabs of patients will be screened for GBS screening
Primary Outcome Measure Information:
Title
Percentage of women with GBS infection
Description
Number of women with GBS infection divided by total number of women under screening
Time Frame
7 days after swab taken
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuong M Ho, MD
Organizational Affiliation
Research Center for Genetics and Reproductive Health
Official's Role
Study Director
Facility Information:
Facility Name
My Duc Hospital
City
Ho Chi Minh City
State/Province
Tan Binh District
ZIP/Postal Code
70000
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
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