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

Phase 1

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Vaginal capsules of lactobacilli

• Registration Number: NCT01421615
• Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-08
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-22
• Last Update Submitted: 2011-08-22
• Study First Posted: 2011-08-23
• Last Update Posted: 2011-08-23
• Primary Completion: 2011-12
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lotion	Vaginal capsules of lactobacilli	lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum.
lactobacilli capsule	Vaginal capsules of lactobacilli	-
lactobacilli capsules	Vaginal capsules of lactobacilli	-

Primary Outcome Measures

Name	Time	Method
Number of Participants who transformed to negative status of bacterial vaginosis	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.

Secondary Outcome Measures

Name	Time	Method
pregnancy outcome of mother	6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)	1. the delivery weeks; 2. the delivery mode; 3. the presence of premature rupture of fetal membra; 4. the presence of premature labor; 5. the volume of postpartum haemorrhage; 6. the presence of pregnancy complications; 7. the highest temperature during the first three days of postpartum
pregnancy outcome of perinatal fetus	6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)	1. the neonatal birth weight; 2. the presence of fetal distress; 3. the neonatal 1 min Apgar score; 4. the numerically highest value of neonatal transcutaneous bilirubinometry
Safety and tolerability	6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)	1. liver function test; 2. renal function test

Trial Locations

Locations (1)

Maternal and child care hospital in Panyu District; 🇨🇳 Guangzhou, Guangdong, China