This study aimed to investigate the effect of yarrow flowers cream compared with povidone-iodine solution, on the healing process of episiotomy wounds.
This study is a randomized clinical trial. Women who give birth in Emam Khomeini hospital and have episiotomy will be allocated randomly (lottery) in the intervention and intervention groups. Inclusion criteria would be primary par women with Natural delivery and Medio lateral episiotomy. In the intervention group, patients will treat with yarrow cream; thus the site of sutures will cover with the cream twice a day (for ten Days). The control group will use the routine care (Betadine solution).
Wound healing will be evaluated using REEDA in seventh and tenth days after delivery. For double-blinding, prescription of drug will be done by one of the researchers and wound healing will be assessed by fellow midwives and data analysis will be done by someone else. We will use the chi-square test, Mann-Whitney, t-test and repeated measures to analysis the data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053134261N1
Registration date:2017-08-10, 1396/05/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-10, 1396/05/19
Registrant information
Name
Azam Rahmani
Name of organization / entity
Nursing and Midwifery Care Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4566
Email address
arahmani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of achillea flowers cream compared to routin care (betadin) on healing of episiotomy in primiparous women: a randomized clinical trial
Public title
The effect of yarrow flowers cream on healing of episiotomy in primiparous women: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:primary par women; natural delivery with medio lateral episiotomy; living with her husband; absence of diseases disturbing wound healing (such as chronic systemic diseases, heart, kidney, liver, respiratory, coagulation, tissue, diabetes, anemia, cancer and mental illness); absence of using drugs affecting wound healing (such as glucocorticoids, anticoagulants, immunosuppressant, antibiotics and chemotherapy drugs); single fetus with anterior cephalic presentation; absence of symptomatic infection of the vagina and vulva (infectious discharge, itching and burning sensation); no obvious abnormalities in infants (hydrocephalus, ascites, a huge mass in the body); no Rectocele and severe Cystocels (grade 2 and above) or vaginal mass; no history of obstetric problems (placenta previa, placental abruption, multiple pregnancy, polyhydramnios, oligohydramnios, conflict RH, rupture of the membranes more than 12 hours); BMI in limited 19/8-30 kilograms per square meter; absence of reconstructive surgery on the vagina and perineum.
Exclusion criteria: Disordering in the progress of labor (fast delivery and prolonged labor); lasted the second stage of labor more than 2 hours; extending the incision and converting into the 3rd and 4th degree tears or extending tears other than episiotomy; abnormal vaginal bleeding (abnormal vaginal bleeding that requires further evaluation by valve); shoulder dystocia that led to the use of non-Mac Robert maneuvers; Placental withdrawal by hand.
Age
No age limit
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Nursing and Midwifery faculty, Tehran University of Medical Sciences
Street address
Nursing and Midwifery University, Mirkhani Street,Towhid Square
City
Tehran
Postal code
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2245
Health conditions studied
1
Description of health condition studied
Wound Healing
ICD-10 code
o90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
wound healing
Timepoint
1th, 7th and 10th day after intervention
Method of measurement
REEDA
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, patients will treat with yarrow cream; thus the site of sutures will cover with the cream (1.5 percent) twice a day (for ten Days).
Category
Treatment - Drugs
2
Description
The control group will be placed under routine care (iodine solution). The diluted solution will be made up and used twice a day (for ten days) by patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tehran University of Medical Sciences
Full name of responsible person
Mis Kardan Moghaddam
Street address
Central Building of Tehran University of Medical Sciences, Ghods Street, Keshavarz Bolvar, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ms KArdan-moghaddam
Position
Research expert
Other areas of specialty/work
Street address
Central Building of Tehran University of Medical Sciences, Ghods Street, Keshavrz Bolvar, Tehran.
City
Tehran
Postal code
Phone
+98 21 8163 3605
Fax
Email
azamrahmani7@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azam Rahmani
Position
PhD
Other areas of specialty/work
Street address
Nursing and Midwifery care research center, Tehran faculty of Nursing and Midwifery, Mirkhani street, Towhid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4566
Fax
Email
arahmai!@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery Care Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Azam Rahmani
Position
Assisstant Professor/ PhD
Other areas of specialty/work
Street address
Nursing and Midwifery care research center, Tehran faculty of Nursing and Midwifery, Mirkhani street, Towhid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4566
Fax
Email
arahmani@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)