Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montse Palacio, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00799500
First received: November 28, 2008
Last updated: April 4, 2013
Last verified: April 2013

November 28, 2008
April 4, 2013
January 2007
December 2010   (final data collection date for primary outcome measure)
Preterm delivery rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00799500 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing
Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pregnancy
  • Bacterial Vaginosis
  • Preterm Delivery
Other: Screening
Weekly vaginal pH
  • Experimental: Weekly screening
    Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.
    Intervention: Other: Screening
  • No Intervention: Observation
    Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1049
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women

Exclusion Criteria:

  • Diabetes mellitus (pre-gestational)
  • Hypertension (pre-gestational)
  • Malformations on ultrasonography at 12 weeks
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00799500
FIS06/0559
No
Montse Palacio, Hospital Clinic of Barcelona
Montse Palacio
Not Provided
Not Provided
Hospital Clinic of Barcelona
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP