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Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery

NCT00491270 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-05-25

No results posted yet for this study

Summary

To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.

Conditions

  • Vaginosis, Bacterial
  • Abortion, Spontaneous
  • Premature Birth

Interventions

DEVICE

VS Sense

An applicator to diagnose pH increase above 5.2

Sponsors & Collaborators

  • Common Sense

    collaborator OTHER

  • Western Galilee Hospital-Nahariya

    lead OTHER_GOV

Principal Investigators

  • Jacob Bornstein, MD · Western Galilee Hospital-Nahariya

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2013-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00491270 on ClinicalTrials.gov