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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 Identifier: NCT00799500

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

Condition Intervention
Bacterial Vaginosis
Preterm Delivery
Other: Screening

U.S. FDA Resources
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


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pregnant women

Exclusion Criteria:

  • Diabetes mellitus (pre-gestational)
  • Hypertension (pre-gestational)
  • Malformations on ultrasonography at 12 weeks
  Contacts and Locations
Please refer to this study by its identifier: NCT00799500

Contact: Vicenç Cararach, MD

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 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
Obstetric Labor Complications
Vaginal Diseases
Premature Birth processed this record on January 13, 2009