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| Name | Class |
|---|---|
| Ministry of Health, China | OTHER_GOV |
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The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. It is assumed that the living preparation of lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment can increase the response rate and improve pregnancy outcomes in the durative BV positive patients comparing with one-course one.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lotion | Placebo Comparator | lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum. |
|
| lactobacilli capsule | Experimental |
| |
| lactobacilli capsules | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal capsules of lactobacilli | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who transformed to negative status of bacterial vaginosis | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy outcome of mother |
| 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanfang LEE | Contact | 13928777126 | 13928777126@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanfang Lee, Master | The First Affiliated Hospital of Guangzhou University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and child care hospital in Panyu District | Recruiting | Guangzhou | Guangdong | 511400 | China |
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| Vaginal capsules of lactobacilli | Drug | 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. |
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| pregnancy outcome of perinatal fetus |
| 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum) |
| Safety and tolerability |
| 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum) |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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