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CompletedNCT00799500Updated Apr 5, 2013

Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

An interventional study of Screening in Pregnancy, Bacterial Vaginosis and Preterm Delivery, sponsored by Montse Palacio. Completed at 1 site in Spain. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-05.

Sponsored by Montse Palacio · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,049
Allocation
Non-randomized
Sex
Female
01

Study summary

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

02

Conditions studied

  • Pregnancy
  • Bacterial Vaginosis
  • Preterm Delivery
03

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's enrollment of 1,049 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

Montse Palacio is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pregnant women

Exclusion criteria

Exclusion Criteria:

  • Diabetes mellitus (pre-gestational)
  • Hypertension (pre-gestational)
  • Malformations on ultrasonography at 12 weeks
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,049 participants (actual)

Study arms

  • Experimental
    Weekly screening

    Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination.

    Other: Screening

  • No intervention
    Observation

    Usual care

Interventions

  • OtherScreening

    Weekly vaginal pH

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What researchers measure

Primary outcomes

  1. Preterm delivery rate

    Time frame: 12 months

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Study locations

1 site
  • Hospital Clinic
    Barcelona, Catalonia 08036, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00799500
Lead sponsor
Montse Palacio
Responsible party
Montse Palacio (MD, PhD, Hospital Clinic of Barcelona) — Sponsor-investigator
First posted
Dec 1, 2008
Start date
Jan 2007
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Apr 5, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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