Objective: The main aim is "Combined pharmaco and cryotherapy compared with only pharmacotherapy in symptomatic chronic cervicitis". The more effective and quick treatment of chronic cervicitis in women, prevention of their referral to physicians, promotion of life quality decline of cure costs are the other aims.
Design: Study population are 120 persons in both control and intervention groups that have been chosen from referred women of Mobini hospital - clinic.
Setting and conduct: This double blind clinical trial study is performed in women with symptomatic cervical ectopy. At the first through an interview, demographic data, the duration and symptoms of the disease is recorded on a checklist and then Pap-smear is prepared totally. The fitted women are divided into control and intervention groups.
Inclusion criteria: These criteria are including cervical ectopy, the age between 15-55, married, and symptoms of chronic cervicitis such as pain during intercourse, spotting, vaginal itching and pruritus, hypogastric pain and increasing vaginal discharge. Exclusion criteria are pap-smear class 3 or more vaginal candidiasis and menopause.
Intervention: In both groups drug (Metronidazol) is prescribed. A trained midwife performs cryotherapy in intervention group and cryo-placebo in control group.
Outcome: The main outcome is improvement of vaginal discharge which is evaluated before, one and three months after treatment and recorded in the checklist. They are re-visited by the physician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101719559N1
Registration date:2015-03-16, 1393/12/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-16, 1393/12/25
Registrant information
Name
Jila Agah
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 8104
Email address
agahj@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2014-10-27, 1393/08/05
Expected recruitment end date
2014-12-24, 1393/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined pharmaco and Cryotherapy compared with only pharmacotherapy in symptomatic chronic cervicitis
Public title
Efficacy of freeze in treatment of cervical erosion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Married, Symptoms of chronic cervicitis including: Increase of vaginal discharge, pain during intercourse, vaginal itching and pruritus, age between 15-55 years old
Exclusion: Acute vaginal candidiasis, menopause
Age
From 15 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The randomization is performed by the random number table. Blinding is performed as the trained midwife uses Cryo-therapy and Cryo-placebo by accidental allocation. Whereas the researchers , participants and analysts are unaware of the kind of intervention for each person. Although pharmacotherapy is the same for both groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Central organization of Sabzevar University of Medical Sciences, Asadabadi St., Sabzevar
City
Sabzevar
Postal code
9613873137
Approval date
2014-05-12, 1393/02/22
Ethics committee reference number
Medsab.Rec.93.3
Health conditions studied
1
Description of health condition studied
Symptomatic chronic cervicitis
ICD-10 code
N72
ICD-10 code description
Endocervicitis with or without erosion or ectropion
Primary outcomes
1
Description
Vaginal discharge
Timepoint
One and three months after treatment
Method of measurement
Check list
Secondary outcomes
1
Description
vaginal itching and pruritus
Timepoint
1 and 3 months after treatment
Method of measurement
Check list
2
Description
Dyspareunia
Timepoint
1 and 3 months after treatment
Method of measurement
Check list
Intervention groups
1
Description
Intervention: Metronidazol( Alborz Darou pharmaceutical Co.)500 mg given orally twice a day until 10 days. Also cryotherapy in cervix was done with N2o(C 501, EMD Co; Tehran, Iran) until forming ice ball in position for every patient.
Category
Other
2
Description
Control: Metronidazol( Alborz Darou pharmaceutical Co.)500 mg given orally twice a day until 10 days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobini hospital of Sabzevar
Full name of responsible person
Jila Agah
Street address
Mobini hospital, Kashefi St., Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Mohammadzadeh
Street address
Vice chancellor for research, Sabzevar University of Medical Sciences, next Way Police, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
393010204
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Jila Agah
Position
Assistant professor, Gynaecologist
Other areas of specialty/work
Street address
Mobini hospital, Kashefi St., Sabzevar
City
Sabzevar
Postal code
96138733119
Phone
+98 51 4423 8104
Fax
+98 51 4422 1002
Email
Jilaagah@yahoo.com
Web page address
medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Jila Agah
Position
Assistant professor, Gynaecologist
Other areas of specialty/work
Street address
Mobini hospital, Kashefi St., Sabzevar
City
Sabzevar
Postal code
9613873119
Phone
+98 51 4423 2040
Fax
+98 51 4422 1002
Email
agahj@medsab.ac.ir; Jilaagah@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Jila Agah
Position
Assistant professor, Gynaecologist
Other areas of specialty/work
Street address
Mobini hospital, Kashefi St., Sabzevar
City
Sabzevar
Postal code
9613873119
Phone
+98 544232040
Fax
+98 44221002
Email
agahj@medsab.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)