The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women
Design
Clinical trials with controlled, triple blind, randomized trials
Settings and conduct
This research will be carried in Motahari Hospital of Marvdasht on 80 nulliparous women with Natural vaginal delivery, including the criteria for entering the study on episiotomy . This is a triple blind study.
Researcher, patient and analyst will be blind.
To randomly assign samples to each of the two intervention and control groups, four variable blocks are used.Then, in the intervention group, the rosemary cream and the control group from the placebo cream will be used for episiotomy
Participants/Inclusion and exclusion criteria
Inclusion criteria: nulliparous؛
Gestational age Between 37-42 weeks؛
The age of the mother Between 18-35 years old؛
Single baby؛
Cephalic؛
Natural vaginal delivery and Middle lateral episiotomy؛
Baby weight between 2500-4000 grams؛
No use effective medication for wound healing؛
Lack of amniotic membrane rupture for more than 12 hours؛
Not having midwifery problems at admission؛
exclusion criteria:
Increased episiotomy؛
Hematoma in episiotomy after childbirth؛
Unwillingness to continue participating in the study؛
No used the correct cream؛
Mother's sensitivity to the Creams used in the study؛
Symptoms of infection in episiotomy؛
opened Episiotomy؛
Shoulder Dystopia
Intervention groups
In the intervention group, Rosemary cream is used twice a day until the tenth day after delivery on episiotomy ulcer. In the control group, placebo cream is also used in the same way
Main outcome variables
pain intensity and wound healing of episiotomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190308042971N1
Registration date:2019-08-24, 1398/06/02
Registration timing:registered_while_recruiting
Last update:2019-08-24, 1398/06/02
Update count:1
Registration date
2019-08-24, 1398/06/02
Registrant information
Name
Fariba Mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4331 7002
Email address
mardani.f.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-21, 1398/04/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women
Public title
The effect of Rosemary cream on pain intensity and wound healing of episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:Completion of informed consent form
Gestational age Between 37-42 weeks
The age of the mother Between 18-35 years old
Single baby
Cephalic
Natural vaginal delivery and Middle lateral episiotomy
Baby weight between 2500-4000 grams
Iranian-Resident of Marvdasht city and The villages around it
Minimum fifth grade primary education
Mother in active phase of labor (dilatation 3-4 cm and regular uterine contractions)و
BMI is 18/5-24/9 kg / m2
Mother lives with hers husband
nulliparous
Exclusion criteria:
indication for cesarean section(Distress fetal, umbilical cord prolapse, diagnosis of the Tight pelvis by the doctor)
having midwifery problems at admission(placenta previa،Polyhydramnios، Oligo Hydramnios)
amniotic membrane rupture for more than 12 hours
clear symptoms of perineal and vaginal infection at the time of admission
anemia or thrombocytopenia
having diabetes, anemia,Immune system disorders,...
use effective medication for wound healing(Glucocorticoids, anticoagulants, immunosuppressants, chemotherapy, alcohol and benzodiazepines)
use of drugs and tobacco
anal lesions, Perineum or history of surgery on Perineum and cystocel and severe rectus
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign samples to each of the two intervention and control groups, four variable blocks are used. In this way, six of the possible blocks (BBAA, BABA, ABBA, BAAB AABB, ABAB) are first listed, and each one is assigned a number from one to six. Then, randomly, a number is selected from one to six, followed by individuals assigned to the test group (A) and control (B), based on the corresponding block. This will continue until the sample size is completed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blindness, the drugs prepared with codes A and B were prepared by the pharmacist's assistant, and only themselves knew about their content, the researcher and consultant of statistics and patients did not know the type of cream.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnical Committee of Gonabad University of Medical Sciences
Street address
Asian Roadside،Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.GMU.REC.1397.089
Health conditions studied
1
Description of health condition studied
episiotomy
ICD-10 code
O70.1
ICD-10 code description
Second degree perineal laceration during delivery
Primary outcomes
1
Description
wound healing of episiotomy
Timepoint
1-5-10 days after childbirth
Method of measurement
Perineal Improvement Assessment Scale (REEDA)
2
Description
pain intensity
Timepoint
1-5-10 days after childbirth
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rosemary Cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site
Category
Treatment - Drugs
2
Description
Control group: Placebo cream 30 grams twice a day for 10 days (prepared at the Pharmacological Research Center of Mashhad Medicinal Plants) will be applied to the amount of a fingertip locally on the episiotomy site
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital of Marvdasht
Full name of responsible person
Fariba Mardani
Street address
Teacher's Street
City
Marvdasht
Province
Fars
Postal code
7371676711
Phone
+98 71 4334 2060
Fax
+98 71 4333 4935
Email
mardanif110@gmail.com
Web page address
https://marvhosp.sums.ac.ir/?sub=38
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
shahla khosravan
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
khosravan@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh hadizadeh Talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 517223028
Email
shahnazhadizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh hadizadeh Talasaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 517223028
Email
shahnazhadizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fariba Mardani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Asian Roadside , Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
Email
mardani.f.stu@gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant information is confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available