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Sponsored by: |
Hospital Clinic of Barcelona |
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Information provided by: | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00799500 |
Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.
Condition | Intervention |
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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. |
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 |
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Weekly screening: Experimental
Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.
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Other: Screening
Weekly vaginal pH
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Observation: No Intervention
Usual care
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vicenç Cararach, MD | vcararac@clinic.ub.es |
Spain, Catalonia | |
Hospital Clinic | Recruiting |
Barcelona, Catalonia, Spain, 08036 | |
Principal Investigator: Vicenç Cararach, MD, PhD |
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 |
Genital Diseases, Female Bacterial Infections Pregnancy Complications Vaginosis, Bacterial Obstetric Labor, Premature |
Vaginitis Obstetric Labor Complications Vaginal Diseases Premature Birth |