NCT03303859

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Status
completed

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

December 18, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2.5 years

First QC Date

October 3, 2017

Last Update Submit

May 28, 2018

Conditions

Bacterial Vaginosis

Keywords

Bacterial vaginosis, preterm delivery, Martinique, stress

Outcome Measures

Primary Outcomes (1)

  • Preterm delivery before 37 weeks gestation

    Rate of preterm delivery

    37 weeks gestation

Interventions

Bacterial vaginosisDIAGNOSTIC_TEST

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All women followed-up since the beginning of pregnancy in the study center and supposed to deliver in this same center

You may not qualify if:

  • Previous preterm delivery,
  • Previous late abortion,
  • Multiple pregnancy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vaginosis, BacterialPremature Birth

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy Complications

Study Officials

  • Jean-Luc VOLUMENIE

    CHU de Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 6, 2017

Study Start

December 18, 2013

Primary Completion

June 26, 2016

Study Completion

June 23, 2017

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share