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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
Li Yanfang, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01421615
First received: August 8, 2011
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: Vaginal capsules of lactobacilli
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Related Pregnancy Outcomes

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Number of Participants who transformed to negative status of bacterial vaginosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • pregnancy outcome of mother [ Time Frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum) ] [ Designated as safety issue: Yes ]
    1. liver function test
    2. renal function test


Estimated Enrollment: 5000
Study Start Date: January 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421615

Contacts
Contact: Yanfang LEE 13928777126 13928777126@139.com

Locations
China, Guangdong
Maternal and child care hospital in Panyu District Recruiting
Guangzhou, Guangdong, China, 511400
Contact: Yanfang LEE    13928777126    13928777126@139.com   
Principal Investigator: Yanfang LEE         
Sponsors and Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Ministry of Health, China
Investigators
Principal Investigator: Yanfang Lee, Master the First Affiliated Hospital of Guangzhou University of TCM
  More Information

No publications provided

Responsible Party: Li Yanfang, No, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01421615     History of Changes
Other Study ID Numbers: GZ board of health
Study First Received: August 8, 2011
Last Updated: August 22, 2011
Health Authority: China: Ministry of Health

Keywords provided by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine:
Bacterial vaginosis
Probiotics
Lactobacilli
Pregnancy outcome
Randomized controlled trial

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
Vaginitis

ClinicalTrials.gov processed this record on October 23, 2014