This clinical trial study was conducted on 474 pregnant women at gestational stage between (2007) and (2008) years.the participants were randomly divided into two groups (intervention group and control group). Screening was performed in intervention group with amsel's criteria (3 of 4 needed for diagnosis). Positive cases were given cream clindamycin 2%for one week; then the outcome of the delivery was assessed in both groups. the data were analysed by spss 11 using descriptive statistics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204219525N1
Registration date:2012-06-06, 1391/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-06, 1391/03/17
Registrant information
Name
Mehrnaz Mashoufi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 0052
Email address
m.mashoufi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2007-03-21, 1386/01/01
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effectiveness of bacterial vaginosis screening program in routine perinatal care and its effect on decrease of preterm labour
Public title
Assessment the effectiveness of bacterial vaginosis screening program in routine perinatal care and its effect on decrease of preterm labour
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-35 years old; gestational age between 8-24 weeks and obtained writing consent.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
474
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
medical ethics committee name
Street address
ardabil university of medical science, adrabil, Iran
City
ardabil
Postal code
Approval date
2007-02-04, 1385/11/15
Ethics committee reference number
904/6
Health conditions studied
1
Description of health condition studied
bacterial vaginosis
ICD-10 code
O23.5
ICD-10 code description
infections of the genital tract in pregnancy
Primary outcomes
1
Description
preterm delivery
Timepoint
termination of pregnancy
Method of measurement
date entry of delivery
Secondary outcomes
1
Description
preterm delivery
Timepoint
termination of pregnancy
Method of measurement
date entry of pregnancy
Intervention groups
1
Description
Intervention group was provied sample vaginal discharge then based on Amsel,s criteria(3 of 4 needed for diagnosis) confirmed bacterial vaginosis.
positive cases were given cream clindamycin 2% for one week and were made follow up for two week after treatment.then, the outcome of the delivery was assessted in the group.
Category
Prevention
2
Description
Control group recived routin care pregnancy without screening for bacterial vaginosis.then the outcome of the delivery was assessted in the group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shal medical health center
Full name of responsible person
Street address
khalkhal- kulur- Shal- Shal medical health center
City
khalkhal
2
Recruitment center
Name of recruitment center
No.1 medical health center
Full name of responsible person
Street address
No.1 medical health center, khalkhal
City
khalkhal
3
Recruitment center
Name of recruitment center
Kulur medical health center
Full name of responsible person
Street address
Kulur medical health center, Kulur, KhalKhal
City
Kulur, KhalKhal
4
Recruitment center
Name of recruitment center
Barandagh medical health center
Full name of responsible person
Street address
Barandagh medical health center- Barandagh- Khalkhal
City
Khalkhal
5
Recruitment center
Name of recruitment center
Beiragh medical health center
Full name of responsible person
Street address
Beiragh medical health center- Barandagh- Khalkhal
City
Khalkhal
6
Recruitment center
Name of recruitment center
Hashtjin medical center
Full name of responsible person
Street address
Hashtjin medical center, Hashtjin, khalkhal
City
Khalkhal
7
Recruitment center
Name of recruitment center
No.2 medical health center
Full name of responsible person
Street address
No.2 medical health center- Khalkhal
City
Khalkhal
8
Recruitment center
Name of recruitment center
Lerd medical health center
Full name of responsible person
Street address
Lerd medical health center- Khalkhal
City
Khalkhal
9
Recruitment center
Name of recruitment center
No. 3 medical health center
Full name of responsible person
Street address
No. 3 medical health center- Khalkhal
City
Khalkhal
10
Recruitment center
Name of recruitment center
Khojin medical health center
Full name of responsible person
Street address
Khojin medical health center- Khalkhal
City
Khalkhal
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil university of medical science
Full name of responsible person
Dr.Hadi Piri Doghahe
Street address
research deputy-Ardabil university of medical science-Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil university of medical science
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
Ardabil University of Medical Sciences
Full name of responsible person
Mehrnaz Mashoufi
Position
MSc/lecturer
Other areas of specialty/work
Street address
Faculty of health, Ardabil University of Medical Sciences, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1551 0052
Fax
Email
m.mashoufi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehrnaz Mashoufi
Position
MS.c
Other areas of specialty/work
Street address
Faculty of health, Ardabil University of Medical Sciences, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1551 0052
Fax
Email
m.mashoufi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehrnaz Mashoufi
Position
lecturer/MS.c
Other areas of specialty/work
Street address
Faculty of health, Ardabil University of Medical Sciences, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1551 0052
Fax
Email
m.mashoufi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)