Protocol summary

Study aim
Determination of the effect of hydroalcoholic extract of clove plantlets on the severity of pain and Wound Healing in mothers
Design
The clinical trial has two groups of control and intermediate, two blind and randomized control group
Settings and conduct
146 pregnant women over 20 weeks of age and those who are pregnant are referred to the health centers. Using the random number table, the sample size is completed and then again using the random numbers of the individuals into two groups Intervention and control will be allocated.On the mothers' checklist, they will be written in the intervention and control groups A and B . Then, at the time of delivery and after the episiotomy, the sample is entered into the study. Which is given to the mothers in the intervention group of glass and the solution of cloves, and to the control group of glass containing distilled water, and the use of the solution for both groups will be explained. This study is also a blind one.
Participants/Inclusion and exclusion criteria
Age aged 18-35, Have at least read and write,Having a natural delivery plan, Negative relationship, no indication for cesarean section, Body mass index in range 19.8-29,Embryo unit with Vertex display,Not having a midwifery history,Maternal admission after the 20th week of pregnancy,  Pregnancy longer than or equal to 37 weeks,No history of medical and mental illness,Lack of curettage,Rupture of curtains less 10 hours,No history of reconstructive surgery on the vagina and mandarin,No use of certain medications
Intervention groups
Mothers in the intervention group will receive 0.25 mg of clove solution and the mothers will be given the same amount of distilled water as the placebo and the mother will be asked to mix 0.25 mg of the solution twice in 10 days in 4 liters of water and sit for 30 minutes in it.
Main outcome variables
Episiotomy pain; Wound Healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181216041990N1
Registration date: 2018-12-26, 1397/10/05
Registration timing: prospective

Last update: 2018-12-26, 1397/10/05
Update count: 0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Saeideh Rajabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3273 1424
Email address
s.rajabzadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of hydroalcoholic extract of Clove plants on the Severity of Pain and Episiotomy Wound Healing inPregnant mothers
Public title
Investigating the Effect of hydroalcoholic extract of Clove plants on the Severity of Pain and Episiotomy Wound Healing inPregnant mothers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age aged 18-35 Have at least read and write Having a natural delivery plan Life with yours Not having an indication for cesarean section Body mass index in range 19.8-29 Embryo unit with Vertex display Having a midwifery history Maternal admission after the 20th week of pregnancy No history of medical and mental illness Rupture of curtains less 10 hours Lack of curettage No history of reconstructive surgery on the vagina and mandarin No use of certain medications
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 146
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant women are assigned to a randomized and assigned sample size and inclusion criteria are assigned to intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participating mothers will not be informed about the type of the use of the solution. Also, the clinical care and research will not be informed about the type of solution.
Placebo
Used
Assignment
Single
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
Gonabad University of Medical Sciences,Sentoo road border,GonabadTown
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.GMU.REC.1397.090

Health conditions studied

1

Description of health condition studied
the Severity of Pain and Episiotomy Wound Healing
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
the Severity of Pain and Episiotomy Wound Healing
Timepoint
Before intervention and On days 3 to 5 and 10 after intervention
Method of measurement
Visual Analogue Scale and REDA

Secondary outcomes

1

Description
Pain rate
Timepoint
Before the intervention and every 3 to 5 and 10 days after the intervention
Method of measurement
Visual Analogue Scale

2

Description
episiotomy Woud healing
Timepoint
Before the intervention and every 3 to 5 and 10 days after the intervention
Method of measurement
READA

Intervention groups

1

Description
Intervention group: Take 0.25 ml of clove extract in 4 liters of water and leave twice for 30 minutes.
Category
Treatment - Other

2

Description
Control group: Place 0.25 ml of the placebo solution in 4 liters of water and sit twice for 30 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Ferdows Hospital
Full name of responsible person
Saeideh Rajabzadeh
Street address
Shahid chamran Hospital, Motehari street
City
Ferdows
Province
South Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 56 3272 2801
Email
s.rajabzadeh@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr.Sayed Ali Sajjadi
Street address
Gonabad University of Medical Sciences,the beginning of the Sento Road.Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
sajjadi@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
Saeideh Rajabzadeh
Position
Students
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, the beginning of the Sento Road.Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
s.rajabzadeh@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Saeideh Rajabzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Beginning of the Sento Road.Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
s.rajabzadeh@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Saeideh Rajabzadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Beginning of the Sento Road. Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
s.rajabzadeh@gmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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