Bacterial Vaginosis in Pregnancy: Detection by Weekly Vag... | NCT00799500

Studies
Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

NCT00799500

Sponsor

Montse Palacio

Status

Completed

Last Update Posted

Apr 5, 2013Estimated

Enrollment

1,049Actual

Phase

Not Applicable

Conditions

Pregnancy
Bacterial Vaginosis
Preterm Delivery

Interventions

Screening

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 28, 2008

First Submission Date that Met QC Criteria

Nov 28, 2008

First Posted Date

Dec 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2013

Last Update Posted Date

Apr 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,049Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Screening	Other	Weekly vaginal pH	Weekly screening

Measure	Description	Time Frame
Preterm delivery rate		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic		Barcelona	Catalonia	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial
D047928	Premature Birth

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008403	Mass Screening

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006306	Health Surveys
D011795	Surveys and Questionnaires

Browse Leaves

Not provided

Browse Branches

Not provided