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The comparison of the effectiveness of phenytoin cream with placebo on episiotomy healing in primipara women

Protocol summary

Summary
The aim of this study is effect of Phenytoin cream on episiotomy wound healing in primipara women refering to Kowsar Hospital in Qazvin 2014-2015. Inclusion criteria: The women with 18-35 years old and full term pregnancy, singleton and normal vaginal delivery with episiotomy. Exclusion criteria: Extended Episiotomy, manipulation of the perineum, uterus and cervixe. In this double blind clinical trial, 130 primiparous women who met inclusion criteria was randomly allocated one of two groups of 65 each into intervention or control group. The questionnaire provided information on individual and obstetrics in the delivery room is completed. After the episiotomy wound healing researcher in the maternity ward after training on wound care and emphasis on personal hygiene and proper nutrition, Coded medications, including phenytoin cream 1% in sterile tube and povidone-iodine solution, in the intervention group and povidone-iodine solution with placebo cream phenytoin in the control group to be delivered mothers. Participants in the phenytoin group used adequate amount area 2 times daily and povidon iodine solution for 10 days after delivery and in cntrol group group used povidon iodine solution with placebo cream. wound healing was assessed with REEDA scale (redness, edema, ecchymosis, discharge, near the edge of the wound)primarily in 24 hours,5 and 10 days after delivery and in the questionnaire will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201510118611N1
Registration date: 2015-11-09, 1394/08/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-09, 1394/08/18
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of phenytoin cream with placebo on episiotomy healing in primipara women
Public title
Effect of Phenytoin cream on incision due to normal vaginal delivery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The women with 18-35 years old and full term pregnancy (37 to 42 weeks) being nulliparous; no specific diseases (cardiovascular; hepatic; renal; diabetes; coagulopathy diseases; anemia); non- obese (BMI<29; according to the same scale); singelton; cephalic presentation; episiotomy on gynecological bed; time of repair less than 30 minutes; episiotomy repair by chromic catgut sutures. exclusion criteria: Hematomas during and after the repair of episiotomy; extended Episiotomy; excessive bleeding after childbirth; manipulation of the perineum, uterus and cervixe; prolonged rupture of amniotic sac more than 18 hour; use of assistive devices (vacum during delivery); no smoking and alcohol.
Age
From 18 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 130
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 Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
4321102589
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
د/10740/20

Health conditions studied

1

Description of health condition studied
Disruption of Episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound

Primary outcomes

1

Description
Episiotomy wound healing
Timepoint
24 hours, 5 and 10 days after delivery
Method of measurement
Reeda scale (redness, edema, ecchymosis, discharge, near the edge of the wound)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: phenytoin sodium cream 1% of the drug distribution company Tehran - Iran and Betadine solution purchased 10% of the pharmaceutical company's medipharm Kish - Iran
Category
Treatment - Drugs

2

Description
Control group: Placebo phenytoin sodium cream of the drug distribution company Tehran - Iran and Betadine solution purchased 10% of the pharmaceutical company's medipharm Kish - Iran
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Hamideh Pakniat
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Street address
Iran, Qazvin, Bahonar Blvd
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
+98 28 3324 2661
Email
pakniat110@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Iran, Qazvin, Bahonar Blvd
City
Qazvin
Postal code
1317634156
Phone
+98 28 3223 6375
Fax
+98 28 3324 2661
Email
pakniat110@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
1317634156
Phone
+98 28 3333 6001
Fax
+98 28 3324 2661
Email
pakniat110@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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