Clinical Trial of Comparison the Effect of Gynophilus Vaginal Capsule and Clindamycine Gel on Treatment of Bacterial Vaginosis among Pregnant Women under 20 Weeks of Gestation
The Aim of This Study is to Compare the Effect of Gynophilus Vaginal Capsule and Clindamycin Gel on Treatment of Bacterial Vaginosis among Pregnant Women under 20 Weeks of Gestation Referred to Sayad-Shirazi Tertiary Hospital.
Inclusion Criteria Include Pregnant women under 20 Weeks of Gestation with Bacterial Vaginosis, Filing the Informed Consent Form and No Vaginal Bleeding and Exclusion Criteria include No Tendency to Participate in the Study after Entering to the Study, Incomplete Consumption of Medications and No Referring for Second and Third Examinations.
In This Single Blind Study, 150 Women with Bacterial Vaginosis Will Be Assigned to Two Groups of 75 Women by Simple Random Allocation.
Gynophilus Vaginal Capsule Containing 341 mg Will Be Prescribed for Intervention Group, Twice a Day for 7 days and Clindamycin Vaginal Gel Will Be Prescribed 5 gm Once a Day for 7 Days.
Then, Samples will Be Evaluated for Recurrence of Disease after 7 Days and 1 Month Later. Moreover, All These Women Will Be Followed until Delivery and They Will Be Evaluated for Preterm Labor and Premature Rupture of Membrane (PROM) and Their Neonate will be evaluated for Birth Weight and APGAR Score at 1st and 5th Minute of Birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040817167N1
Registration date:2014-06-29, 1393/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-29, 1393/04/08
Registrant information
Name
soudeh ramazanpour
Name of organization / entity
golestan medical university
Country
Iran (Islamic Republic of)
Phone
+98 17 3372 3054
Email address
dr.ramazanpour@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Comparison the Effect of Gynophilus Vaginal Capsule and Clindamycine Gel on Treatment of Bacterial Vaginosis among Pregnant Women under 20 Weeks of Gestation
Public title
Effect of Gynophilus Capsule on Treatment of Bacterial Vaginosis (BV)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant Women under 20 Weeks` Gestation with Bacterial Vaginosis; Filing the Informed Consent Form; No Vaginal Bleeding. Exclusion Criteria: No Tendency to Participate in the Study after Entering to the Study; Incomplete Consumption of Medications; No Referring for Second or Third Examinations.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Shastkola Road, Golestan University of Medical Scienecs, Gorgan, Iran
City
Gorgan
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
23279208121
Health conditions studied
1
Description of health condition studied
Bacterial Vaginosis
ICD-10 code
N76
ICD-10 code description
Other inflammation of vagina and vulva
Primary outcomes
1
Description
Recurrence
Timepoint
One Month after Treatment
Method of measurement
AMSEL Criteria
2
Description
Cure
Timepoint
One Week after Treatment
Method of measurement
AMSEL Criteria
Secondary outcomes
1
Description
Premature Rupture of Membrane
Timepoint
Total Duration of Pregnancy
Method of measurement
Gestational Age Less Than 37 Weeks
2
Description
Preterm labor
Timepoint
Total Duration of Pregnancy
Method of measurement
Gestational Age Less Than 37 Weeks
3
Description
Neonate`s APGAR score
Timepoint
First and Ffth Minute of Birth
Method of measurement
APGAR Score Table
4
Description
Birth Weight of Neonate
Timepoint
After Birth
Method of measurement
Scale
Intervention groups
1
Description
Intervention: Administration of Gynophilus Vaginal Capsule, Containing of 341 mg, Twice a Day, For 7 Days.
Category
Treatment - Drugs
2
Description
Control: Administration of Clindamycin Vaginal Gel, One Applicator about to 5 mg, Once a Day, for 7 Days.