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Effect of plantago major cream on perineal pain and episiotomy wound healing at primeval women

Protocol summary

Study aim
Determination of the Effect of plantago major cream on perineal pain and episiotomy wound healing at primeval women
Design
The study will include two groups of medicines for120 eligible women
Settings and conduct
Drug and drug coding will be done by the pharmacist.the study will take place within 10 days and will be completed within 14days.Research units of prenatal women are referred to the hospital
Participants/Inclusion and exclusion criteria
Primeval, Reading and writing literacy, 18-35 year, Not having genital disease, lack of cesarean section, No pelvic tightness, Active phase when admitted, BMI:19/8-29, No having vaginal problems,no use of effectivr drug for episiotomy ulcer repair during the study; Childbirth with the device, Curettage, Repture grades 3 and 4 , Hematoma at the suture site, Mathers transfer to the operating room, Unblocking stitches, Vaginal infection, Cervical rupture, Consumption of creem unlike ordar, The baby is admitted to the nicu
Intervention groups
In the group and placebo, daily intake of bacon will be done and both will carry out routine care at the hospital
Main outcome variables
Prineal pain and episiotomy wound healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180729040631N1
Registration date: 2018-09-13, 1397/06/22
Registration timing: prospective

Last update: 2018-09-13, 1397/06/22
Update count: 0
Registration date
2018-09-13, 1397/06/22
Registrant information
Name
Bahare Baghal
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3245 0316
Email address
baghalb951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of plantago major cream on perineal pain and episiotomy wound healing at primeval women
Public title
Effect of plantago major cream on perineal pain and episiotomy wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primeval Reading and writing literacy 18_35 year Not having genital disease Lack of cesarean section No pelvic tightness Active phase when admitted BMI:19/8-29 No having vaginal problems No use of effective drug for episiotomy ulcer repair during the study
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected by convenient metod. The code A and B , one for the drug and the other for the placebo, is placed in a container and allocated to the research units, respectively.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The same packaging and drug coding will be done by the pharmacist.The investingator and the research unit and the person who imprts the statistical data do not know the drug and the prescriber.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics committee of the Mashhad Medical science University
Street address
University street, Quraishi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.013

Health conditions studied

1

Description of health condition studied
Perineal pain and episiotomy wound healing
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Perineal pain and episiotomy wound healing
Timepoint
14 day
Method of measurement
Reeda Questionnaire and McGill pain Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Daily intake twice creem
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Nahid ghanbarzadeh
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9177116763
Phone
+98 56 3244 3000
Email
Nghanbarzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rahele babazadeh
Street address
University of nersing, Faculty nersing and midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9913197319
Phone
+98 51 3859 1511
Email
Babazadehr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Bahare Baghal
Position
Senior midwifery student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
University of nersing, Faculty of nersing snd midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 56 3245 0316
Email
Baghalb951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rahele Babazade
Position
Professer
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
University of nersing , Faculty of nersing and midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Babazadehr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahare Baghsl
Position
Senior midwifery student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
University of Nursing , Faculty of Nersing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 56 3245 0316
Email
Baghalb951@mums.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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