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

August 22, 2011 updated by: Li Yanfang, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

5000

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • Maternal and child care hospital in Panyu District
        • Contact:
        • Principal Investigator:
          • Yanfang LEE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: lotion
lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum.
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.
Other Names:
  • Brand names: Dingjunsheng
  • Commodity code name: A246912309879
  • Approved by the state: S20030005
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.
Other Names:
  • Brand names: Dingjunsheng
  • Commodity code name: A246912309879
  • Approved by the state: S20030005
EXPERIMENTAL: lactobacilli capsule
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.
Other Names:
  • Brand names: Dingjunsheng
  • Commodity code name: A246912309879
  • Approved by the state: S20030005
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.
Other Names:
  • Brand names: Dingjunsheng
  • Commodity code name: A246912309879
  • Approved by the state: S20030005
EXPERIMENTAL: lactobacilli capsules
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.
Other Names:
  • Brand names: Dingjunsheng
  • Commodity code name: A246912309879
  • Approved by the state: S20030005
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.
Other Names:
  • Brand names: Dingjunsheng
  • Commodity code name: A246912309879
  • Approved by the state: S20030005

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who transformed to negative status of bacterial vaginosis
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy outcome of mother
Time Frame: 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
6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
pregnancy outcome of perinatal fetus
Time Frame: 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
6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
Safety and tolerability
Time Frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)
  1. liver function test
  2. renal function test
6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Collaborators

Ministry of Health, China

Investigators

  • Principal Investigator: Yanfang Lee, Master, The First Affiliated Hospital of Guangzhou University of TCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (ESTIMATE)

August 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 22, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZ board of health

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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