Protocol summary
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Study aim
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The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women
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Design
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Clinical trials with controlled, triple blind, randomized trials
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Settings and conduct
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This research will be carried in Motahari Hospital of Marvdasht on 92 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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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pain intensity and wound healing of episiotomy
General information
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Reason for update
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Enter the start and end dates of the completed sampling and the volume of the completed sample
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190308042971N1
Registration date:
2019-08-24, 1398/06/02
Registration timing:
prospective
Last update:
2022-01-31, 1400/11/11
Update count:
1
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Registration date
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2019-08-24, 1398/06/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-21, 1398/04/30
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Expected recruitment end date
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2019-10-22, 1398/07/30
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Actual recruitment start date
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2019-09-01, 1398/06/10
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Actual recruitment end date
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2020-03-05, 1398/12/15
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Trial completion date
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2020-03-19, 1398/12/29
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Scientific title
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The effect of Rosemary cream on pain intensity and wound healing of episiotomy in nulliparous women
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Public title
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The effect of Rosemary cream on pain intensity and wound healing of episiotomy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
92
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-03, 1397/09/12
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Ethics committee reference number
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IR.GMU.REC.1397.089
Health conditions studied
1
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Description of health condition studied
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episiotomy
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ICD-10 code
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O70.1
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ICD-10 code description
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Second degree perineal laceration during delivery
Primary outcomes
1
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Description
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wound healing of episiotomy
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Timepoint
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1-4-10 days after childbirth
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Method of measurement
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Perineal Improvement Assessment Scale (REEDA)
2
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Description
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pain intensity
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Timepoint
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1-4-10 days after childbirth
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Gonabad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only part of the data such as information about the main outcome or the like can be shared.
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When the data will become available and for how long
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6 months after printing the results
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To whom data/document is available
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Medical researchers
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Under which criteria data/document could be used
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Available at the reasonable request of researchers.
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From where data/document is obtainable
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Corresponding author of the published article
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What processes are involved for a request to access data/document
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Send email to the Corresponding author
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Comments
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