Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedApril 21, 2017
April 1, 2017
10 months
October 21, 2015
April 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Group B Streptococcus (GBS) screening
EXPERIMENTALVaginal and anal swab of patients will be screened for GBS screening
Interventions
Vaginal and anal swabs of patients will be screened for GBS screening
Eligibility Criteria
You may qualify if:
- 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)
- /7 to 36 6/7 weeks of gestation
- Intact membrane
- Cervical dilation ≤ 3 cm
- Willing to participate into the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manh Tuong Holead
Study Sites (1)
My Duc Hospital
Ho Chi Minh City, Tan Binh District, 70000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tuong M Ho, MD
Research Center for Genetics and Reproductive Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 21, 2015
First Posted
April 21, 2017
Study Start
October 1, 2015
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
April 21, 2017
Record last verified: 2017-04