The purpose of this study is evaluating the effect of hypericum perforatum cream on the episiotomy wound healing and common discontent after childbirth in primiparous women. This randomized double -blind clinical trial will do on 100 nulliparous women with mediolateral episiotomy who admitted in Talesh shahid noorani hospital. The creams will produce by advicer pharmacist in Shahid Beheshti pharmacy faculty in similar color and will put into similar tubes with label A and B. then will gived the participants after checking the inclusion and exclusion criteria, with randomized method. And will asked from participants to use topically one finger of the cream on episiotomy wounds twice for ten days. Perineal pain intensity and wound healing will evaluated in first 12 hours and 5,10 days after delivery by using Visual Analogue Scale (VAS) and REEDA scoring scale. Common postpartum discontent will assessed with scholar made questionnaire on 10th day.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501253860N12
Registration date:2015-04-29, 1394/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-29, 1394/02/09
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research of school of nursing and midwifery Shahid Beheshti university of medical sciences.
Dr Kiandokht Ghanati
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hypericum Perforatum cream on the episiotomy wound healing and common discontent after childbirth in primiparous women
Public title
The effect of Hypericum Perforatum cream on the episiotomy wound healing and common discontent after childbirth in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primiparous woman; aged 18 to 35 years; have a vaginal delivery with mediolateral episiotomy without instrumental delivery and tears; singleton birth with cephalic presentation; was educated; resident in talesh; gestational ages must be between 37 to 42 weeks; child weights must be between 2500 to 4000 grams; the lack of diseases history such as chronic systemic disorders; cardiovascular; Respiratory; coagulation disorders and connective tissue; diabetes; anemia; immunosuppressant; hemophilia; malnutrition and psychological disorders; no allergies to topical drugs; no rupture of membranes more than 24 hours; no addiction; BMI between 19.8-30 kg/m2; no manual removal of placenta; no fetal anomaly or bedfast to the neonatal unit; not taking the first stage of labor (more than 14 hours) and the second stage of labor (more than 2 hours) and the third stage of labor (more than 1 hours). Exclusion criteria: do not visit for care; do not use hypericum cream properly and as directed; not interested to continue to participate in the study; not allergy to use hypericum cream; have a sex in the first 5 days after birth; manipulation of the perineum after episiotomy repair; use drugs on wound healing (anticoagulant, antidepressants, antiepileptic, alcohol, glucocorticoids; immunosuppressant drugs) during the study; not have episiotomy hematoma in the first 24 hours after delivery.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Shahid Beheshti University of Medical Sciences
Street address
Tehran, Shahid Abbas poor Street
City
Tehran
Postal code
Approval date
2015-01-19, 1393/10/29
Ethics committee reference number
1000/2578
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
090/1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Intensity of episiotomy pain
Timepoint
before intervention, 12 hours, 5 and 10 days postpartum.
Method of measurement
Visual Analogue Scale (VAS)
2
Description
wound healing of episiotomy
Timepoint
before intervention, 12 hours, 5 and 10 days postpartum.
Method of measurement
REEDA scale
3
Description
common discontent after childbirth
Timepoint
10days after delivery
Method of measurement
questionnaire
Secondary outcomes
1
Description
Sedative tablets counting
Timepoint
10 day after delivery
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Hypericum cream (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days.
Category
Treatment - Drugs
2
Description
In control group; placebo cream (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Noorani Hospital
Full name of responsible person
Somaye Yahya
Street address
City
Talesh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of school of nursing and midwifery Shahid Beheshti university of medic
Full name of responsible person
Dr Kiandokht Ghanati
Street address
Shahid Abbaspoor street, Valiasr St, Tehran, Iran
City
Tehran
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 school of nursing and midwifery Shahid Beheshti university of medic
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 of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
Phd of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
g.ozgoli@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
PHD of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Valiasr St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
g.ozgoli@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)