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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

August 8, 2011
August 22, 2011
January 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01421615 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Bacterial Vaginosis
  • 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
  • Placebo Comparator: lotion
    lotion:the patients in control group receive washing medicine and are followed up to the 4rd~7th days of postpartum.
    Interventions:
    • Drug: Vaginal capsules of lactobacilli
    • Drug: Vaginal capsules of lactobacilli
  • Experimental: lactobacilli capsule
    Interventions:
    • Drug: Vaginal capsules of lactobacilli
    • Drug: Vaginal capsules of lactobacilli
  • Experimental: lactobacilli capsules
    Intervention: Drug: Vaginal capsules of lactobacilli
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
May 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
20 Years to 50 Years
Yes
Contact: Yanfang LEE 13928777126 13928777126@139.com
China
 
NCT01421615
GZ board of health
Yes
Li Yanfang, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Ministry of Health, China
Principal Investigator: Yanfang Lee, Master the First Affiliated Hospital of Guangzhou University of TCM
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP