Vaginosis, BacterialNCT00484653
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
A study testing cervical smear in people with Vaginosis, Bacterial, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.
Trial summary
This is a prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC). There is a correlation between premature delivery and bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginosis, Bacterial
- What is being tested?
- cervical smear
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 6 sitesFrance
- Study dates
- Jul 2007to Jul 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant patients aged more than 18 years and more than 14 weeks of gestation but less than 28 weeks.
- Multiple pregnancy won't be included.
- Patient with a risk of premature delivery with a short cervix or a cervix measured at less than 25 mm (measure done by vaginal ultrasound of the cervix).
- Or patient with a past of premature delivery and/or of late abortion.
- Symptomatic or asymptomatic patient.
- Patients consulting for pregnancy follow up or hospitalized in a unit of Gynecology and Obstetrics involved in the study.
- social security cover
- written informed consent
Who cannot join
- antecedents : treated hypertension, Foetal malformation, APLS known, diabetes, renal disease, SLE
- treated with antibiotics the inclusion's day
- dropping consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Antoine BECLERE
Clamart, 92140
Hôpital Saint Joseph
Marseille, 13008
Hôpital Nord-OB/GYN Department
Marseille, 13015
Hôpital de la Conception
Marseille, 13385
Centre Hospitalier Poissy-Saint-Germain
Poissy, 78303
Centre médicochirurgical et obstétrical
Schiltigheim, 67303
About this study
This is a prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC).
There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies of vaginal flora are a potential target for the campaign against prematurity.
Read more
The main objective of this study is to achieve an objective and reproducible technique of identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies.
The secondary objectives are the exhaustive culture of bacteria, the characterisation of intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the ribosomic ADN 16S coupled with clonage techniques.
The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).
- Conditions
- Vaginosis, Bacterial
- Being tested
- cervical smear
- Keywords
- To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical smearProcedure or surgery
biological analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BRETELLE, PU-PH, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484653
- Sponsor's protocol ID
- 2007/07
- Status last verified
- Aug 2014
- First submitted
- 8 Jun 2007
- Last updated
- 28 Aug 2014
- Results posted
- No
Publications
Bretelle F, Rozenberg P, Pascal A, Favre R, Bohec C, Loundou A, Senat MV, Aissi G, Lesavre N, Brunet J, Heckenroth H, Luton D, Raoult D, Fenollar F; Groupe de Recherche en Obstetrique Gynecologie. High Atopobium vaginae and Gardnerella vaginalis vaginal loads are associated with preterm birth. Clin Infect Dis. 2015 Mar 15;60(6):860-7. doi: 10.1093/cid/ciu966. Epub 2014 Dec 1.
PubMed 25452591Menard JP, Fenollar F, Raoult D, Boubli L, Bretelle F. Self-collected vaginal swabs for the quantitative real-time polymerase chain reaction assay of Atopobium vaginae and Gardnerella vaginalis and the diagnosis of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):513-8. doi: 10.1007/s10096-011-1341-8. Epub 2011 Jul 26.
PubMed 21789604Menard JP, Mazouni C, Salem-Cherif I, Fenollar F, Raoult D, Boubli L, Gamerre M, Bretelle F. High vaginal concentrations of Atopobium vaginae and Gardnerella vaginalis in women undergoing preterm labor. Obstet Gynecol. 2010 Jan;115(1):134-140. doi: 10.1097/AOG.0b013e3181c391d7.
PubMed 20027045
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
- ClinicalTrials.gov ID
- NCT00484653
- Acronym / sponsor ID
- 2007/07
- Conditions
- Vaginosis, Bacterial
- Keywords
- To achieve a quality and quantitative molecular biology assay for vaginal flora abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Jun 2007 (estimated)
- 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 prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC).
There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies of vaginal flora are a potential target for the campaign against prematurity.
The main objective of this study is to achieve an objective and reproducible technique of identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies.
The secondary objectives are the exhaustive culture of bacteria, the characterisation of intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the ribosomic ADN 16S coupled with clonage techniques.
The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant patients aged more than 18 years and more than 14 weeks of gestation but less than 28 weeks.
- Multiple pregnancy won't be included.
- Patient with a risk of premature delivery with a short cervix or a cervix measured at less than 25 mm (measure done by vaginal ultrasound of the cervix).
- Or patient with a past of premature delivery and/or of late abortion.
- Symptomatic or asymptomatic patient.
Key exclusion criteria (3 listed)
- antecedents : treated hypertension, Foetal malformation, APLS known, diabetes, renal disease, SLE
- treated with antibiotics the inclusion's day
- dropping consent.
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 |
|---|---|---|
| cervical smearbiological analysis | Procedure or surgery | – |
Primary outcome
identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Derived from this study: PubMed 25452591Bretelle F, Rozenberg P, Pascal A, Favre R, Bohec C, Loundou A, Senat MV, Aissi G, Lesavre N, Brunet J, Heckenroth H, Luton D, Raoult D, Fenollar F; Groupe de Recherche en Obstetrique Gynecologie. High Atopobium vaginae and Gardnerella vaginalis vaginal loads are associated with preterm birth. Clin Infect Dis. 2015 Mar 15;60(6):860-7. doi: 10.1093/cid/ciu966. Epub 2014 Dec 1.
- Derived from this study: PubMed 21789604Menard JP, Fenollar F, Raoult D, Boubli L, Bretelle F. Self-collected vaginal swabs for the quantitative real-time polymerase chain reaction assay of Atopobium vaginae and Gardnerella vaginalis and the diagnosis of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):513-8. doi: 10.1007/s10096-011-1341-8. Epub 2011 Jul 26.
- Derived from this study: PubMed 20027045Menard JP, Mazouni C, Salem-Cherif I, Fenollar F, Raoult D, Boubli L, Gamerre M, Bretelle F. High vaginal concentrations of Atopobium vaginae and Gardnerella vaginalis in women undergoing preterm labor. Obstet Gynecol. 2010 Jan;115(1):134-140. doi: 10.1097/AOG.0b013e3181c391d7.
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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.
Florence BRETELLE, PU-PH principal investigator
Assistance Publique Hôpitaux de Marseille
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical smear in people with Vaginosis, Bacterial, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484653, which also lists 3 linked publications.
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 28 Aug 2014.