- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01421615
Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes (BV)
Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Related Pregnancy Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research method: This was a single-blind randomized controlled trial.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Yanfang LEE
- Phone Number: 13928777126
- Email: 13928777126@139.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 511400
- Recruiting
- Maternal and child care hospital in Panyu District
-
Contact:
- Yanfang LEE
- Phone Number: 13928777126
- Email: 13928777126@139.com
-
Principal Investigator:
- Yanfang LEE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pregnant women at 16-18 gestational weeks with no history of premature labor or premature rupture of fetal membranes.
Exclusion Criteria:
- who have menstrual disorder or forget the last menstrual period, and have no type-B ultrasonic result, so the gestational week is not clear.
- Who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases.
- who have severe medicochirurgic diseases.
- multiple pregnancy.
- anomalies of genital tract
- fetal anomaly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: lotion
lotion:the patients in control group receive washing medicine and are followed up to the 4rd~7th days of postpartum.
|
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.
Other Names:
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 Names:
|
EXPERIMENTAL: lactobacilli capsule
|
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.
Other Names:
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 Names:
|
EXPERIMENTAL: lactobacilli capsules
|
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.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants who transformed to negative status of bacterial vaginosis
Time Frame: 6 months
|
The patients who were BV positive would receive treatment and be repeatedly evaluated BV status on the time of post-treatment 1 week, 28th gestational weeks, and before birth, respectively.The number of Participants who transformed to negative status of bacterial vaginosis will be recorded.
The rates of bacterial vaginosis transformed to negative status will be calculated.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pregnancy outcome of mother
Time Frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
|
|
6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
|
pregnancy outcome of perinatal fetus
Time Frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
|
|
6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
|
Safety and tolerability
Time Frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
|
|
6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yanfang Lee, Master, The First Affiliated Hospital of Guangzhou University of TCM
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GZ board of health
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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