NCT01421615

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

Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Related Pregnancy Outcomes

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2012-05-01
• First posted: 2011-08-23
• Last updated: 2011-08-23

Locations

1 site across 1 country: China