Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes (BV)

Guangzhou University of Chinese Medicine

Status and phase: Unknown; Phase 1

Conditions: Bacterial Vaginosis

Treatments: Drug: Vaginal capsules of lactobacilli

Study type: Interventional

Funder types: Other

Identifiers

NCT01421615

GZ board of health

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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5,000 participants in 3 patient groups, including a placebo group

lotion

Placebo Comparator group

Description:

lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum.

Treatment:

Drug: Vaginal capsules of lactobacilli

Drug: Vaginal capsules of lactobacilli

lactobacilli capsule

Experimental group

Treatment:

Drug: Vaginal capsules of lactobacilli

Drug: Vaginal capsules of lactobacilli

lactobacilli capsules

Experimental group

Treatment:

Drug: Vaginal capsules of lactobacilli

Drug: Vaginal capsules of lactobacilli