Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

This study is currently recruiting participants.

Verified by Hospital Clinic of Barcelona, November 2008

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00799500

Purpose

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

Condition	Intervention
Pregnancy Bacterial Vaginosis Preterm Delivery	Other: Screening

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study
Official Title:	Impact on Prematurity of a First-Trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Crossover, Community Study.

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Preterm delivery rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3600
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Weekly screening: Experimental Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.	Other: Screening Weekly vaginal pH
Observation: No Intervention Usual care

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799500

Contacts

Contact: Vicenç Cararach, MD

Locations

Spain, Catalonia
Hospital Clinic	Recruiting
Barcelona, Catalonia, Spain, 08036
Principal Investigator: Vicenç Cararach, MD, PhD

Sponsors and Collaborators

Hospital Clinic of Barcelona

More Information

Responsible Party:	ICGON Hospital Clínic, Barcelona ( Vicenç Cararach )
Study ID Numbers:	FIS06/0559
Study First Received:	November 28, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00799500
Health Authority:	Spain: Ethics Committee

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Pregnancy Complications
Vaginosis, Bacterial
Obstetric Labor, Premature

Vaginitis
Obstetric Labor Complications
Vaginal Diseases
Premature Birth

ClinicalTrials.gov processed this record on January 13, 2009