The objective of this study was to compare normal saline and Betadine solution in episiotomy wound healing. This study was a randomized controlled trial, in which 120 nuliparous or multiparous women with episiotomy were randomly assigned into intervention or control group. For the patients in the intervention group, 10cc normal saline, 9 in 1000 cc, was sprinkled on episiotomy wound by a sterile syringe, three times a day for ten days. In the control group, 10% povidone iodine solution, three tablespoons in four glasses of water three times a day, was used similarly as the normal saline. Episiotomy wound were checked based on the standard REEDA checklist (erythema, edema, ecchymosis, and wound secretion) on the fifth and tenth day after episiotomy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012221839N3
Registration date:2011-01-08, 1389/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-08, 1389/10/18
Registrant information
Name
Mahtab Attarha
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 861417350009
Email address
m.attarha@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2010-02-23, 1388/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of normal saline with Betadine solution in episiotomy wound healing
Public title
Episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: full term pregnancy, singelton pregnancy with normal vaginal delivery, spontaneous placenta removal, PROM less than 18 hours, no illnesses that affect wound healing such as: cardiac, pulmonary, kidney disease, diabetes, anemia, coagolopathy and malnutrition
Exclusion criteria: require to any antibiotics or immunosuppressive drugs during the study, change in location, not coming on the examination date and cases have not been instructed the plan of study
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics committee of Arak University Medical Sciences
Street address
Second Floor of Education Department Building, Pardis Building Complex, Arak University Medical Sciences, Sardasht Sq.
City
Arak
Postal code
76941-38481
Approval date
2009-07-23, 1388/05/01
Ethics committee reference number
4-60-88
Health conditions studied
1
Description of health condition studied
Episiotomy Wound Healing
ICD-10 code
O00, O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Episiotomy wound healing
Timepoint
The third, seventh and tenth days during treatment
Method of measurement
Rate of healing
Secondary outcomes
1
Description
Edema, inflammation and redness
Timepoint
The third, seventh and tenth during treatment
Method of measurement
Reeda score
Intervention groups
1
Description
Intervention group: 10 cc saline normal (9 in 1000 cc), manufactured by Samen Pharmaceutical Co., was sprinkled on episiotomy wound by a sterile syringe, three times a day for ten days
Category
Treatment - Drugs
2
Description
Control group: 10 cc povidone iodine solution 10%, three tablespoons in four glasses of water, manufactured by Samen Pharmaceutical Co., was sprinkled on episiotomy wound by a sterile syringe, three times a day for ten days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Treatment Center of Ayatollah Taleghani
Full name of responsible person
Mahtab Attarha
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University Medical Sciences
Full name of responsible person
Davood Hekmat Poo
Street address
Second Floor of Education Department Building, Pardis Building Complex, Arak University Medical Sciences, Sardasht Sq.
City
Arak
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 Arak University 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
Nursing and Midwifery Faculty of Arak University Medical Sciences
Full name of responsible person
Mahtab Attarha
Position
Istractor, academician
Other areas of specialty/work
Street address
Second Floor of Education Department Building, Pardis Building Complex, Arak University Medical Sciences, Sardasht Sq.
City
Arak
Postal code
Phone
+98 86 1417 3516
Fax
Email
mahtab_at2004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Midwifery Faculty Of Arak University Medical Sciences
Full name of responsible person
Mahtab Attarha
Position
Instructor, academician
Other areas of specialty/work
Street address
Second Floor of Education Department Building, Pardis Building Complex, Arak University Medical Sciences, Sardasht Sq.
City
Arak
Postal code
Phone
+98 86 1417 3516
Fax
Email
mahtab_at2004@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mahtab Attarha
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)