Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

NCT ID: NCT00799500

Last Updated: 2013-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1049 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Pregnancy Bacterial Vaginosis Preterm Delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Weekly screening

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

Group Type EXPERIMENTAL

Screening

Intervention Type OTHER

Weekly vaginal pH

Observation

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Screening

Weekly vaginal pH

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women

Exclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Montse Palacio

OTHER

Sponsor Role lead

Responsible Party

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Montse Palacio

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Clinic

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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FIS06/0559

Identifier Type: -

Identifier Source: org_study_id

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