Clinical trial NCT01421615: Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes
Official title: Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Related Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bacterial Vaginosis
Keywords: Bacterial vaginosis
Probiotics
Lactobacilli
Pregnancy outcome
Randomized controlled trial
Lead sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2011-08-23
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants who transformed to negative status of bacterial vaginosis
timeFrame: 6 months
Secondary outcomes:
measure: pregnancy outcome of mother
timeFrame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
measure: pregnancy outcome of perinatal fetus
timeFrame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
measure: Safety and tolerability
timeFrame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Maternal and child care hospital in Panyu District
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou University of TCM
name: Yanfang Lee, Master
role: PRINCIPAL_INVESTIGATOR
References: