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NCT00799500 Clinical Trial

Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

Pregnancy Clinical Trial

Official title:
Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00799500
Other study ID # FIS06/0559
Secondary ID
Status Completed
Phase N/A
First received November 28, 2008
Last updated April 4, 2013
Start date January 2007
Est. completion date December 2010

Study information
Verified date April 2013
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1049
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Pregnant women

Exclusion Criteria:

- Diabetes mellitus (pre-gestational)

- Hypertension (pre-gestational)

- Malformations on ultrasonography at 12 weeks

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Screening
Weekly vaginal pH

Locations
Country Name City State
Spain Hospital Clinic Barcelona Catalonia

Sponsors (1)
Lead Sponsor Collaborator
Montse Palacio

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preterm delivery rate 12 months Yes
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