Back to resultsBacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing
Primary Purpose
Pregnancy, Bacterial Vaginosis, Preterm Delivery
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Screening
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
Exclusion Criteria:
- Diabetes mellitus (pre-gestational)
- Hypertension (pre-gestational)
- Malformations on ultrasonography at 12 weeks
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Weekly screening
Observation
Arm Description
Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.
Usual care
Outcomes
Primary Outcome Measures
Preterm delivery rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00799500
Brief Title
Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Montse Palacio
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Bacterial Vaginosis, Preterm Delivery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1049 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weekly screening
Arm Type
Experimental
Arm Description
Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
Weekly vaginal pH
Primary Outcome Measure Information:
Title
Preterm delivery rate
Time Frame
12 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women
Exclusion Criteria:
Diabetes mellitus (pre-gestational)
Hypertension (pre-gestational)
Malformations on ultrasonography at 12 weeks
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing
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