NCT00799500

Brief Summary

Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,049

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

3.9 years

First QC Date

November 28, 2008

Last Update Submit

April 4, 2013

Conditions

PregnancyBacterial VaginosisPreterm Delivery

Outcome Measures

Primary Outcomes (1)

  • Preterm delivery rate

    12 months

Study Arms (2)

Weekly screening

EXPERIMENTAL

Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.

Other: Screening

Observation

NO INTERVENTION

Usual care

Interventions

ScreeningOTHER

Weekly vaginal pH

Weekly screening

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women

You may not qualify if:

  • Diabetes mellitus (pre-gestational)
  • Hypertension (pre-gestational)
  • Malformations on ultrasonography at 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Vaginosis, BacterialPremature Birth

Interventions

Mass Screening

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 28, 2008

First Posted

December 1, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

ES(1)