Assessment of the therapeutic effects of probiotic yougurt in comparison with clindamycin in the treatment of bacterial vaginosis in patients in the third trimester of pregnancy referring to prenatal clinic of Imam hospital
This study was performed to determine the efficacy of probiotic yoghurt and clindamycin in the treatment of bacterial vaginosis in pregnant women in the second and third trimester, referring to Imam Hospital. In this randomized clinical trial, 300 pregnant women in the second and third trimester, after diagnosis of bacterial vaginosis, were assigned to receive either probiotic yoghurt (100 gram twice a day for one week) or orally-administered clindamycin (300 mg twice a day for one week). The patients were visited after one week of therapy for recurrence of symptoms and recheck of vaginal PH and were followed until the end of pregnancy for symptom recurrence with phone call and pregnancy outcomes (pretem labor, PROM) were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104136183N1
Registration date:2011-04-23, 1390/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-23, 1390/02/03
Registrant information
Name
Fateme Golshahi
Name of organization / entity
Tehran Univ of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 2690
Email address
golshahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-08-10, 1388/05/19
Expected recruitment end date
2010-12-15, 1389/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the therapeutic effects of probiotic yougurt in comparison with clindamycin in the treatment of bacterial vaginosis in patients in the third trimester of pregnancy referring to prenatal clinic of Imam hospital
Public title
Comparative efficacy of probiotic yoghurt and clindamycin in the treatment of bacterial vaginosis in pregnant women in the third trimester
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women in second or third trimester of pregnancy who had bacterial vaginosis according to the presence of minimally three Amsel Criteria, willing to participate
Exclusion criteria: having a positive history of background disease, positive urine culture, having a positive history of preterm labor and premature rupture of the membranes, other vaginal infections
Age
From 16 years old to 44 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine, Tehran University of Medical Sciences
Street address
Poorsina St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2009-06-27, 1388/04/06
Ethics committee reference number
841
Health conditions studied
1
Description of health condition studied
Acute vaginitis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
Bacterial vaginosis
Timepoint
before and after intervention
Method of measurement
turnessel paper
Secondary outcomes
1
Description
preterm labor
Timepoint
before 37 weeks gestational age
Method of measurement
diagnosis of gynecologist
2
Description
preterm rupture of membranes
Timepoint
before 37 weeks of gestational age
Method of measurement
diagnosis of a gynecologist
3
Description
update: June 30, 2011; Recurrence Rate
Timepoint
-
Method of measurement
-
4
Description
Update June 30, 2011; PH Level
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention: probiotic yoghurt (100 gram twice a day for one week)
Category
Treatment - Other
2
Description
Control: orally-administered clindamycin (300 mg twice a day for one week).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hospital, Clinic of Prenatal
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Maryam Ojaghi
Street address
Poorsina St, Blvd Keshavarz
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medicine, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran Univ of medical sciences
Full name of responsible person
Fateme Golshahi
Position
Resident of Ob & Gyn
Other areas of specialty/work
Street address
Imam hospital, Dept of Gyn
City
Tehran
Postal code
Phone
+98 21 6695 2690
Fax
Email
golshahi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Univ of Medical Sciences
Full name of responsible person
Sedighe Hantoushzadeh
Position
Associate professor of Gyn
Other areas of specialty/work
Street address
Dept of Gyn, Imam hospital
City
Tehran
Postal code
Phone
+98 21 6119 2365
Fax
Email
hantoushzadeh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Univ of Medical Sciences
Full name of responsible person
Fateme Golshahi
Position
Resident of Ob& Gyn
Other areas of specialty/work
Street address
Imam hospital, Dept of Gyn
City
Tehran
Postal code
Phone
Fax
Email
golshahi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)