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

Bacterial Vaginosis Clinical Trial

— BV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01421615
• Other study ID #: GZ board of health
• Status: Recruiting
• Phase: Phase 1
• First received: August 8, 2011
• Last updated: August 22, 2011
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2011
• Source: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Contact: Yanfang LEE
• Phone: 13928777126
• Email: 13928777126[@]139.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Maternal and child care hospital in Panyu District	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine	Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who transformed to negative status of bacterial vaginosis	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	No
Secondary	pregnancy outcome of mother	the delivery weeks; the delivery mode; the presence of premature rupture of fetal membra; the presence of premature labor; the volume of postpartum haemorrhage; the presence of pregnancy complications; the highest temperature during the first three days of postpartum	6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)	No
Secondary	pregnancy outcome of perinatal fetus	the neonatal birth weight; the presence of fetal distress; the neonatal 1 min Apgar score; the numerically highest value of neonatal transcutaneous bilirubinometry	6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)	No
Secondary	Safety and tolerability	liver function test; renal function test	6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum)	Yes