Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

• Sponsor: Montse Palacio (Other)
• Overall Status: Completed
• CT.gov ID: NCT00799500
• Collaborator: (none)
• Enrollment: 1,049
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 22.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Bacterial Vaginosis; Preterm Delivery	Other: Screening	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1049 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Preterm delivery rate [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinic	Barcelona	Catalonia	Spain	08036

Sponsors and Collaborators

• Montse Palacio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montse Palacio, MD, PhD, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT00799500
• Other Study ID Numbers: FIS06/0559
• First Posted: Dec 1, 2008
• Last Update Posted: Apr 5, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Premature Birth

Study Results

No Results Posted as of Apr 5, 2013