The purpose of this study is to analyze effects of Calendula ointment on healing and pain intensity of cesarean section localized wound in primiparous women.with considering inclusion criteria: (being primiparous women with age range20-37 years; gestational age 37 - 42 weeks; ability to read and write; Not having history of allergies to any topical medicine; Not addiction to tobacco, drugs and psychotropic; Avoiding use of anticoagulants, antidepressants, anticonvulsants and drugs that weaken the immune system; No history of previous surgical incision cesarean section (above the symphysis pubis); Lack PROM> 18 hours; Not having a body mass index> 35,10; Lateral-lower uterine incision and pfannenstiel technique skin incision; No accumulation of fat in the abdomen; lack of abnormal vaginal bleeding; Spinal anesthesia; The same type of stitches; Presence of attendant with patient; Using chromic suture to the mucous and silk for skin), Exclusion criteria: ( Lack of improper use of marigold ointment or Vaseline ointment based on form was developed according to subjects; unwillingness to continue to participate in the study; using other drugs or methods of healing; using medications affecting wound healing (golocortical - anticoagulant - modulator - broad-spectrum antibiotics - Antihistamines - chemotherapy and radiotherapy); occurring any infection or bleeding at the wound that requires medical intervention with considering random sampling on 108 women who have cesarean incision will be randomly divided into 2 intervention and 1 control group. One of the Intervention groups will use calendula ointment on cesarean incision. the other group will use placebo ointment on cesarean incision every 12 hours. Control group will not use anything on cesarean incision. Our scale to check the pain reliving is VAS ruler and Our scale to check the wound healing is REEDA table. We check the pain and wound healing before intervention then 3 day, 6day and 9 day after starting intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507252248N18
Registration date:2015-11-05, 1394/08/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-05, 1394/08/14
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-08-04, 1394/05/13
Expected recruitment end date
2016-08-03, 1395/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Calendula ointment on healing and pain localized wound cesarean section in nulliparous women
Public title
The Effect of Calendula ointment on healing and pain localized wound cesarean section in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: (being primiparous women with age range20-37 years; gestational age 37 - 42 weeks; ability to read and write; Not having history of allergies to any topical medicine; Not addiction to tobacco, drugs and psychotropic; Avoiding use of anticoagulants, antidepressants, anticonvulsants and drugs that weaken the immune system; No history of previous surgical incision cesarean section (above the symphysis pubis); Lack PROM> 18 hours; Not having a body mass index> 35,10; Lateral-lower uterine incision and pfannenstiel technique skin incision; No accumulation of fat in the abdomen; lack of abnormal vaginal bleeding; Spinal anesthesia; The same type of stitches; Presence of attendant with patient; Using chromic suture to the mucosa and silk for skin), Exclusion criteria: ( Lack of improper use of marigold ointment or Vaseline ointment based on form was developed according to subjects; unwillingness to continue to participate in the study; using other drugs or methods of healing; using medications affecting wound healing (glucocorticoid - anticoagulant - immunomodulator - broad-spectrum antibiotics - Antihistamines - chemotherapy and radiotherapy); occurring any infection or bleeding at the wound that requires medical intervention).
Age
From 20 years old to 36 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Iran University of Medical Sciences
Street address
Next to the Mottahari hospital, Rashid Yasmi street, Valiasr avenue
City
tehran
Postal code
Approval date
2015-07-15, 1394/04/24
Ethics committee reference number
IR.IUMS.REC.1394.25011
Health conditions studied
1
Description of health condition studied
healing and pain localized wound cesarean section
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
Primary outcomes
1
Description
wound healing
Timepoint
befor interventional then 3 day, 6day and 9 day after starting intervention.
Method of measurement
wound healing with REEDA table
Secondary outcomes
1
Description
Caesarean wound severity pain
Timepoint
befor interventional then 3 day, 6day and 9 day after starting intervention.
Method of measurement
severity pain with VAS
Intervention groups
1
Description
Control group follow the routine of the hospital
Category
N/A
2
Description
mothers put placebo ointment 2 times a day until 10days after birth
Category
Placebo
3
Description
mothers put calendula ointment 2 times a day until 10days after birth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid Akbaabadi hospital
Full name of responsible person
Akram haghighi khabbaz
Street address
movlavi street
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr seyed ali javad mosavi
Street address
Shahid hemat highway
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Akram Haghighi Khabbaz
Position
Master of scince student
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid Yasmi street, Valiasr avenue
City
Tehran
Postal code
Phone
00
Fax
Email
ah70.mid18@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fereshte Jahdi
Position
master of scince in midwifery
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue
City
tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
jahdi.fr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Akram Haghighi Khabbaz
Position
Master of scince in midwifery
Other areas of specialty/work
Street address
Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue
City
tehran
Postal code
Phone
00
Fax
Email
ah70.mid18@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)