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The effect of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healing in primiparous women

Protocol summary

Summary
As the episiotomy has physiologic, psychologic and social - economical consequences so, not only the decision to do it but also the manner of performance and the quality of future cares, are important. In traditional medicine, topical usage of Achillea millefolium and Hypericum perforatum oil has showed significant affects on wounds healing. The purpose of this study was assessed the efficacy of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healing in primiparous women. This study is a double blind clinical trial that was performed on 140 primiparous women qualified for the research. After delivery, mothers in one group took no interventions, other groups took placebo ointment, Hypericum perforatum and Achillea millefolium ointments 5%, twice a day for ten days. The healing process was assessed by 5 specifications: redness, ecchymosis, edema, discharge and wound dehiscence at 7th, 10th and 14th days after delivery, pain level was assessed by means of visual analogue scale.Findings of this study showed that there was significant difference between groups in perineal pain level at 7th & 10th & 14th, redness and edema at 7th & 10th and ecchymosis at 7th days postpartum, as pain level, redness, edema and ecchymosis in groups who consume Hypericum perforatum and Achillea millefolium ointments were less than control groups (P<0.05). But discharge and dehiscence incidence showed no significant difference between groups (P>0.05).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072629084N1
Registration date: 2016-08-08, 1395/05/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-08, 1395/05/18
Registrant information
Name
Atefeh Keivani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3225 1195
Email address
ati.keyvani@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healing in primiparous women
Public title
The effect of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: • Being nulliparous • Gestational age of 37-42 weeks • Having a single fetus • Not to use particular medications (such as glucocorticoids, anticoagulant, chemotherapy, immunosuppressant and radiotherapy) • No history of the diseases that disrupt wound healing process such as chronic systemic diseases, cardiac, renal, pulmonary diseases, coagulation disorders, immune deficiency, connective tissue disorder and diabetes • Not having anemia, mental illnesses, persistent constipation, hemorrhoid, hemophilia and malnutrition • no allergic history of herbal medicines • Body mass index of 19/8-26 • having no active skin diseases such as allergic disorders, skin irritation or wound in Incision site and symptomatic vaginitis • Not using antibiotics after episiotomy • no history of perineal repair surgery • no history of genital warts Exclusion critera: • Cephalopelvic disproportion in pelvic exam • Disruption in labor progress (first delivery stage > 20hours, and prolonged second delivery stage > 2hours (prolonged labor) or cervical dilation progress ≥ 5cm in hour or labor duration < 3hours (fast Delivery)) • Manual placental removal • Third and fourth degree perineal laceration • prolonged membrane Rupture (> 18hours) • abnormal postpartum hemorrhage or hematoma • irregular use of ointment (< 7days or 14 times) • onset complications such as itching or skin irritation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Not 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 committe of Shahrekord University of Medical Sceinces
Street address
Kashani avenue
City
Shahrekord
Postal code
8815713471
Approval date
2011-08-21, 1390/05/30
Ethics committee reference number
14_5_90

Health conditions studied

1

Description of health condition studied
episiotomy wound
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound

Primary outcomes

1

Description
pain level
Timepoint
Patient explained perineal pain level by a number of 0-10 at second, 7th & 10th & 14th days postpartum
Method of measurement
visual analogue scale

2

Description
The healing process by 5 specifications: redness, ecchymosis, edema, discharge and wound dehiscence
Timepoint
at 7th, 10th and 14th days after delivery
Method of measurement
researcher assessed redness, edema and ecchymosis in millimeters and charted in perineal repair control form

Secondary outcomes

empty

Intervention groups

1

Description
control group: non-intervention
Category
Other

2

Description
control group: consuming placebo ointment. Placebo ointment was Vaseline without extract in 30gr tubes. The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days.
Category
Placebo

3

Description
case group: consuming Achillea millefolium ointment. Achillea millefolium purchased from medical plants sellers and after proving the identity by Medical Plants Research Center of Shahrekord University of Medical Sciences, made broken then extracted by using Ethanol %90 solotion. The acquired hydroalcoholic extract condensated untill became dry and this condensated extract packed with strile Vaseline as base (%5 weight ratio) in 30gr tubes.The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days.
Category
Treatment - Drugs

4

Description
case group: consuming Hypericum perforatum ointment. Hypericum perforatum purchased from medical plants sellers and after proving the identity by Medical Plants Research Center of Shahrekord University of Medical Sciences, made broken then extracted by using Ethanol %90 solotion. The acquired hydroalcoholic extract condensated untill became dry and this condensated extract packed with strile Vaseline as base (%5 weight ratio) in 30gr tubes.The patients were selected among women who refferd to shahrekord health centers for routine prenatal visits. Before delivery they received necessary training about how care the sutures, personal hygiene, nutrition and physical activity, then they received one coded ointment and educated how to use: first, the perineum should be washed and dried, then at second day postpartum they were asked to use 1cm of ointment on episiotomy site (the sutures), so that ointment cover all surface of incision, then a pad was used; this was continued twice a day for ten days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
health center number 2
Full name of responsible person
Street address
City
shahrekord

2

Recruitment center
Name of recruitment center
health center number 3
Full name of responsible person
Street address
City
shahrekord

3

Recruitment center
Name of recruitment center
Mirabad health center
Full name of responsible person
Street address
City
shahrekord

4

Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Street address
City
shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Medical Sceinces
Full name of responsible person
Vice-Chancellor for Research and Technology Affairs
Street address
Kashani avenue
City
shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sceinces
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
Shahrekord University of Medical Sciences
Full name of responsible person
Atefeh Keivani
Position
medical doctor
Other areas of specialty/work
Street address
Kashani avenue
City
shahrekord
Postal code
Phone
003832251195
Fax
Email
ati.keyvani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Maryam Hajhashemi
Position
gynaecologist
Other areas of specialty/work
Street address
Kashani avenue
City
shahrekord
Postal code
Phone
003833349507
Fax
Email
hajhashemy73@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Atefeh Keivani
Position
medical doctor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
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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