Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes
NCT ID: NCT01421615
Last Updated: 2011-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
5000 participants
INTERVENTIONAL
2011-01-31
2012-05-31
Brief Summary
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Detailed Description
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Diagnostic standard: The study population is the women who have positive outcome of screened test for BV by sialidase method.
Allocation and follow up: Patients who were screened for BV by sialidase method and randomly allocated into control group、one-course group and two-course group. The patients in control group who were BV positive would receive lotion washout and be repeatedly evaluated BV status per two weeks and be followed up to the 4th～7th days of postpartum. The patients in one-course group and in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. The patients in two-course group will receive the second course treatment of Lactobacilli preparation if their BV test result were still positive after one-course treatment, but those in one-course group would NOT receive any treatment even though they would have the durative BV positive result after one-course of Lactobacilli. The patients in the two interventional groups would be repeatedly evaluated BV status at 28th gestational weeks and be followed up to the 4th-7th days of postpartum. All the inspection results of vaginal secretions and pregnancy outcome were recorded.
Outcome measures:
* The prevalence of BV,the response rates of lactobacillus preparation,the recurrence rate.
* The adverse pregnancy outcomes of mother.
* The adverse pregnancy outcomes of perinatal fetus.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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lotion
lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum.
Vaginal capsules of lactobacilli
The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum.
Vaginal capsules of lactobacilli
The patients in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they will receive the second course treatment of Lactobacilli preparation.
lactobacilli capsule
Vaginal capsules of lactobacilli
The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum.
Vaginal capsules of lactobacilli
The patients in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they will receive the second course treatment of Lactobacilli preparation.
lactobacilli capsules
Vaginal capsules of lactobacilli
The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum.
Interventions
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Vaginal capsules of lactobacilli
The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum.
Vaginal capsules of lactobacilli
The patients in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they will receive the second course treatment of Lactobacilli preparation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases.
* who have severe medicochirurgic diseases.
* multiple pregnancy.
* anomalies of genital tract
* fetal anomaly
20 Years
50 Years
FEMALE
Yes
Sponsors
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Ministry of Health, China
OTHER_GOV
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Li Yanfang
Principal Investigators
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Yanfang Lee, Master
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangzhou University of TCM
Locations
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Maternal and child care hospital in Panyu District
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GZ board of health
Identifier Type: -
Identifier Source: org_study_id
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