- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03303859
Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I (VaMap)
May 28, 2018 updated by: University Hospital Center of Martinique
Preterm delivery is a public health priority in Martinique, a French oversees territory located in the Caribbean, with a rate of 10,5% substantially higher than in Continental France (7,5%).
Bacterial vaginosis is an imbalance of vaginal flora known to be associated with preterm delivery risk.
Studies driven in the United States have pointed out that 50% of the excess in preterm birth rate observed in Afro-American population compared to Caucasian population may be attributable to infection.
Bacterial vaginosis appears much more prevalent in our population than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bacterial vaginosis during pregnancy is considered as a risk factor for preterm birth since the 1990's.
A meta-analysis realized in 2003 found an Odds ratio of 2.4 for preterm delivery among women with bacterial vaginosis carriage, culminating at 7.5 when carriage before 17 weeks gestation was considered.
Preterm delivery is a pregnancy complication known to be more prevalent among patients of African descent.
Various hypothesis have been tested to account for this observed discrepancy and several authors consider that up to 50% of the difference in preterm delivery rate between Afro-american and Caucasians may have and infectious origin, with up to 30% attributable to a very different bacterial vaginosis carriage among patients of various ethnic origin.
Several factors may interfere in the link observed between bacterial vaginosis and preterm delivery, which are also unevenly distributed among women of different ethnic origin.
Exposure to stress, low socio-economic status, single marital status or low access to prenatal care are among those factors.
Thus analyzing a relation between bacterial vaginosis and preterm delivery mandates to control for such factors.
The present study will proceed to a vaginal sampling before 17 gestational age (GA) to diagnose a bacterial vaginosis through the Nugent score which is the standard diagnostic method for this pathology.
At the same time, a written survey concerning stressful events in the past 12 months is submitted to volunteer patients in order to use the social readjustment rating scale by Holmes and Rahe and to account for the role of stress as a potential confounding factor.
Socio-demographic data, obstetrical history and complications during pregnancy were also recorded and patients followed-up prospectively until delivery.
Caregivers were blinded to the results of initial vaginal sampling.
No alteration of the normal pregnancy follow-up was required by the study design.
Study Type
Observational
Enrollment (Actual)
511
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Bacterial vaginosis appears much more prevalent in Martinique than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.
Description
Inclusion Criteria:
- All women followed-up since the beginning of pregnancy in the study center and supposed to deliver in this same center
Exclusion Criteria:
- Previous preterm delivery,
- Previous late abortion,
- Multiple pregnancy,
- Cervical cerclage before inclusion
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preterm delivery before 37 weeks gestation
Time Frame: 37 weeks gestation
|
Rate of preterm delivery
|
37 weeks gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean-Luc VOLUMENIE, CHU de Martinique
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 (Actual)
December 18, 2013
Primary Completion (Actual)
June 26, 2016
Study Completion (Actual)
June 23, 2017
Study Registration Dates
First Submitted
October 3, 2017
First Submitted That Met QC Criteria
October 3, 2017
First Posted (Actual)
October 6, 2017
Study Record Updates
Last Update Posted (Actual)
May 30, 2018
Last Update Submitted That Met QC Criteria
May 28, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/B/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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