The project is a double blind clinical trial with 2 group, with purpose is assessment effect of phenytoin cream on healing and reduce of pain of episiotomy incision on mothers with vaginal delivery. The count of sample in each group is 37 person which for increase of the validity of project and falling the samples 45 person estimated. mothers with 18 to 35 years old with first delivery without special disease and using special drugs where include in the project, in 2 group on treatment with 1%phenytoin cream and group with Oserin cream as a placebo. After 10 days assessment of episiotomy healing would be done with REEDA scale 10 and 20 days after delivery by researcher. Pain in 10 and 20 day after delivery would be assessed with visual analog scale and comparison between two groups will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080835575N1
Registration date:2017-08-20, 1396/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Samane Azimi Souteh
Name of organization / entity
Sabzevar University of Medical Sciens
Country
Iran (Islamic Republic of)
Phone
+98 11 3565 9111
Email address
azimis1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Govermental, Vice chancellor for research, Sabzevar Univercity of Medical Sciense
Expected recruitment start date
2017-08-16, 1396/05/25
Expected recruitment end date
2017-12-16, 1396/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the phenytoin cream in comparison with placebo on episiotomy healing and pain reduction in woman with vaginal delivery
Public title
Effect of the phenytoin cream on episiotomy healing and pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : mothers with a term delivery ; women with vaginal delivery and episiotomy incision ; 1 or 2 degree episiotomy incision: not very deep incision ; supporting equipment’s like vacuum were not used in delivery process ; a Medio lateral episiotomy incision ; mothers who are not malnutrition or on specific diet ; first pregnancy ; age between 18 years old until 35 ; not having premature rupture of the membranes (PROM) >18 hr.; not having special disease ( anemia , cardiovascular disease, diabetes mellitus, immune disease, liver disease, depression) ; not smoking or drug user ; ability to read and write ; not being obsess ( BMI < 29)
exclusion criteria: use special drugs like corticosteroid ,anticoagulant, immune system suppressors, wide spectrum antibiotics, anti-histamines, Ca antagonist, chemotherapy and radiotherapy, narcotics ; second repairs after delivery; long time delivery or extreme bleeding after delivery ; obstetrician problems like eclampsia, preeclampsia, placenta Previa, twin or triplet pregnancy , coryoamnionitis. meccunial membranes, polyhidrameniosis ; mothers with infections, abscess and hematoma in perinea
Age
From 17 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Sabzevar University of Medical Sciense
Street address
Khorasan Razavi, Sabzevar
City
Sabzevar
Postal code
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
ir.medsab.rec 1396.23
Health conditions studied
1
Description of health condition studied
episiotomy
ICD-10 code
090.1
ICD-10 code description
complication disruption of episiotomy
Primary outcomes
1
Description
healing - sevierity of pain
Timepoint
10 and 20 days after intervention begining
Method of measurement
REEDA scale for healing- VISUAL ANALOG SCALE for sevierity
Secondary outcomes
1
Description
dehiscence of insicion- scar lenght
Timepoint
10 and 20 days after begining of intervention
Method of measurement
percent of second reparation- centimeter
Intervention groups
1
Description
Interventional group : Phenytoin 1% Cream
Category
Treatment - Drugs
2
Description
Control group: Osserin Cream( placebo)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobini Hospital
Full name of responsible person
Samane Azimi Souteh
Street address
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medical sciens
Full name of responsible person
Elham Bashtani
Street address
Sabzevar University of Medical Sciens
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Sabzevar University of Medical sciens
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
Research andinvestigation commite
Full name of responsible person
Masome Haghighi
Position
Research manager
Other areas of specialty/work
Street address
Central office of Univercity
City
Sabzevar
Postal code
Phone
+98 51 4401 1304
Fax
Email
azimis1@medsab.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mobini hospital
Full name of responsible person
Doctor Behnaz Sovizi
Position
Gyneacologist
Other areas of specialty/work
Street address
Sabzevar, Mobini hospital
City
Sabzevar
Postal code
Phone
+98 51 4423 8100
Fax
Email
behnazsovizi1355@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar Univercity of Medical Sciense
Full name of responsible person
Samane Azimi Souteh
Position
Student
Other areas of specialty/work
Street address
City
Sabzevar
Postal code
Phone
+98 11 3565 9111
Fax
Email
samaneazimi79@yahoo.com ; Azimis1@medsab.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)