Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00799500
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : April 5, 2013
Information provided by (Responsible Party):
Montse Palacio, Hospital Clinic of Barcelona

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

Condition or disease Intervention/treatment Phase
Pregnancy Bacterial Vaginosis Preterm Delivery Other: Screening Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1049 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.
Study Start Date : January 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: Weekly screening
Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.
Other: Screening
Weekly vaginal pH

No Intervention: Observation
Usual care

Primary Outcome Measures :
  1. Preterm delivery rate [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00799500

Hospital Clinic
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Montse Palacio

Responsible Party: Montse Palacio, MD, PhD, Hospital Clinic of Barcelona Identifier: NCT00799500     History of Changes
Other Study ID Numbers: FIS06/0559
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Premature Birth
Genital Diseases, Female
Bacterial Infections
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications