Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

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

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

Condition Intervention
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


Genders 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00799500

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 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
Vaginal Diseases
Genital Diseases, Female
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on April 21, 2014