Preterm LaborNCT03122704
Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
A study testing GBS screening in people with Preterm Labor, run by Manh Tuong Ho at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- GBS screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteVietnam
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- GBS screening
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS screeningProcedure or surgery
Vaginal and anal swabs of patients will be screened for GBS screening
| Study group | Role | What they receive |
|---|---|---|
| Group B Streptococcus (GBS) screening | Experimental | Vaginal and anal swab of patients will be screened for GBS screening Receives: Procedure: GBS screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women with GBS infection
Number of women with GBS infection divided by total number of women under screening
Measured: 7 days after swab taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startOct 2015
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manh Tuong Ho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Tuong M Ho, MD, Study director, Research Center for Genetics and Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122704
- Sponsor's protocol ID
- NCKH/CGRH_09_2015
- Status last verified
- Apr 2017
- First submitted
- 21 Oct 2015
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.
- ClinicalTrials.gov ID
- NCT03122704
- Acronym / sponsor ID
- NCKH/CGRH_09_2015
- Conditions
- Preterm Labor
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Manh Tuong HoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group B Streptococcus (GBS) screening | Experimental | Procedure: GBS screeningVaginal and anal swab of patients will be screened for GBS screening |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBS screeningVaginal and anal swabs of patients will be screened for GBS screening | Procedure or surgery | Group B Streptococcus (GBS) screening |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho, MD study director
Research Center for Genetics and Reproductive Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GBS screening in people with Preterm Labor, run by Manh Tuong Ho at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women with GBS infection (time frame: 7 days after swab taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.