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Comparison of Alfa ointment and Betadin solution on wound healing of episiotomy in primiparous women

Protocol summary

Summary
Episiotomy cutting perineal muscles, with the aim of accelerating the completion of to improve the outcome for mother and baby. Drugs with anti-inflammatory effects, antibacterial activity are suitable for wound healing. Alfa ointment has all of the above. The objective of this study, is to compare Alfa ointment and povidon Iodine solution (Betadin) on wound healing episiotomy. This study is single blind 140 women admitted to hospital Kamali Karaj ,Iran. Nulliparous women aged 18-45 years, cephalic, no history of disease impaired wound healing and not using drugs effecting on wound healing. Samples of available with easy method and using a randomized design with two groups (control group: sitz bath with Povidon Iodine) and (intervention group: sitz bath with Povidone Iodine in addition Alfa ointment). The labor process control and information related to this process. A disruption in the process of labor, delivery devices (vaccum, forceps) have extended, or there was lengh tear except episiotomy tear, the research unit would excluded. Unit of study of prescribed sitz bath with povidon iodine 3times daily for 7 days.Intervention group using Alfa ointment 3times daily for 7 days, placed on the sutures. Episiotomy wound were checked based on the checklist standard REEDA on first, third and seventh days after delivery. Pain of episiotomy, were checked based on the Mac Gill pain router on first, third and seventh days after delivery by the researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015071523230N1
Registration date: 2015-09-24, 1394/07/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-24, 1394/07/02
Registrant information
Name
Peimaneh Naghdi Dorbati
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3255 8920
Email address
mehdizade@karajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University Of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Alfa ointment and Betadin solution on wound healing of episiotomy in primiparous women
Public title
Wound Healing of Episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: primiparous; literate; Iranian; BMI prenatal 19.8_26; no history of disease chronic; liver; renal; diabetes; coagulation disease; anemia; constipation; hemorrhoids; no surgery; no taking anti coagulation; anti epileptic; anti depressants; alcohol; smoking drug; no having active skin disease; allergic disorder; symptomatic vaginitis; wound in place or skin sensitivity; Cephalic presentation; anterior position; lack of long term rapture of membrane (less than 18h) ; first stage for delivery less than14h; second stage for delivery less than 2h; third stage for delivery less than 1h; delivery on pregnancy bed prepared and drp; no grade3 and 4tear; repair of episiotomy using Chromic suture Catgut 0 and 2/0 using the same; episiotomy repaired time less than 25minutes. Exclusion criteria: allergy; no using drugs.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Alborz University of Medical Sciences
Street address
Administrative town, above the right Taleghani, Taleghani Blvd
City
Karaj
Postal code
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
abzums.rec1394.19

Health conditions studied

1

Description of health condition studied
Wound healing of episiotomy
ICD-10 code
000-099
ICD-10 code description
Pregnancy,Child birth and the puerperium

Primary outcomes

1

Description
Wound healing of episiotomy
Timepoint
First, third and seventh day after delivery during treatment
Method of measurement
Rate of healing (REEDA scale)

Secondary outcomes

1

Description
Pain of episiotomy
Timepoint
First, third and seventh day after delivery during threatment
Method of measurement
McGill pain Questionnaire short

Intervention groups

1

Description
Intervention group: use the same protocol Povidon Iodine as sitz bath (30cc Povidon Iodine in 3litre of water) three times a day for seven days, intravenous antibiotic single dose (Cefazolin 2gr) ,Mefenamic Acid capsule 250 mg three times a day for three days ,inaddition Alfa ointment three times a day for seven days (each time a knuckle ointment is placed on the sutures so that the wound is completly coveres)
Category
Treatment - Drugs

2

Description
Control group: use the same protocol Povidon Iodine as sitz bath (30 cc Povidon Iodine in 3 litre of water) three times a day for seven days, intravenous antibiotic single dose (Cefazolin 2 gr) , Mefenamic Acid capsoule 250 mg three times a day for three days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Educational and Treatment Center of Kamali
Full name of responsible person
Naghdi Dorbati Peimaneh
Street address
Right shohada, Karaj
City
karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Drafshi
Street address
Administrative Town, Above the righr Taleghani, Taleghani Blvd
City
karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Naghdi Dorbati Peimaneh
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Administrative Town, Above the Right Taleghani, Taleghani Blvd
City
karaj
Postal code
Phone
+98 26325589204
Fax
+98 26 3255 8932
Email
naghdip52@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz Uuniversity of Medical Sciences
Full name of responsible person
Naghdi Dorbati Peimaneh
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Administrative Town, Above the Right Taleghani, Taleghani Blvd
City
Karaj
Postal code
Phone
+98 26325589204
Fax
+98 26 3255 8932
Email
naghdip52@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Naghdi Dorbati Peimaneh
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Administrative Town, Above the Right Taleghani, Taleghani Blvd
City
karaj
Postal code
Phone
+98 26325589204
Fax
+98 26 3255 8932
Email
naghdip52@gmail.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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