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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
History of Changes
  Purpose

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


Condition Intervention
Pregnancy
Bacterial Vaginosis
Preterm Delivery
 Other: Screening

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Preterm delivery rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 1049
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women

Exclusion Criteria:

  • Diabetes mellitus (pre-gestational)
  • Hypertension (pre-gestational)
  • Malformations on ultrasonography at 12 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799500

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

No publications provided

Responsible Party: Montse Palacio, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00799500     History of Changes
Other Study ID Numbers: FIS06/0559
Study First Received: November 28, 2008
Last Updated: April 4, 2013
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013