Protocol summary
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Study aim
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Evaluate the effect of Boswellia spp. and Commiphora Myrrh and comparing them with betadine solution on repair of the episiotomy wound after normal vaginal delivery, with regard to "REEDA" questionnaire.
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Design
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This is a double-blinded study.90 patients are enrolled in the study. They were divided into three groups accidentally the herbal formulations and also povidone iodine were used as sitz bath twice daily for a week and participants were visited on the o, 2 and 7 day after delivery. REEDA questionnaire have been used to evaluate wound healing.
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Settings and conduct
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This study for evaluate the effect of Myrrh and Boswellia spp.on episiotomy wound healing and compariing it with betadine solution in Hafez and Zeinabie hospital was done. Formulation A, B and C have been administered in the similar bottles, so patients and researchers were unable to detect. Our nurse colleague in this study delivered formulations to the participants of the study according to the randomized block table. At the end of the study, the formulations were decoded and the patients assigned to each group were identified.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: NVD with mediolateral episiotomy; parity 1; normal BMI before pregnancy< 25 ; GA 37 to 42 wks; Available for several post-partum visits
Exclusion Criteria: complications immediately after delivery; instrumental delivery; 3º or 4º degree perineal laceration; who have history of medical problems like diabetes mellitus...; Previous history of perineorrhaphy; perineal hematoma; post-delivery fever > 38; smokers; infection of the episiotomy site; prolonged rupture of membranes
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Intervention groups
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Group intervention 1 received herbal formulation based on Myrrh, group intervention 2 herbal formulation based on Boswellia and control group Betadine solution.
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Main outcome variables
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Wound healing
General information
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Reason for update
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Recording errors
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140525017827N5
Registration date:
2019-07-28, 1398/05/06
Registration timing:
prospective
Last update:
2019-12-23, 1398/10/02
Update count:
3
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Registration date
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2019-07-28, 1398/05/06
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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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2019-07-29, 1398/05/07
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Expected recruitment end date
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2019-10-12, 1398/07/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison Between Commiphora Myrrh, Boswellia Spp. And Betadine Solution For Repair of Episiotomy After Normal Vaginal Delivery
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Public title
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Comparison Between Myrrh, Boswellia And Betadine For Repair 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:
Who have normal vaginal delivery with mediolateral episiotomy.
parity 1
Normal body mass index (BMI) before pregnancy (less than 25).
Gestational age 37 to 42 weeks
Available for several post partum visits
Exclusion criteria:
Mothers who have complications immediately after devilry
instrumental delivery
3º or 4º degree perineal laceration
who have history of medical problems like diabetes mellitus, hypertention, anemia, Rheumatology disease...
Previous history of perineorrhaphy
perineal hematoma
post delivery fever upper than 38 degree of centigrade
smokers
infection of the episiotomy site
prolonged rupture of membranes
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Age
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From 18 years old to 41 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:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Formulation A, B and C have been administered in the similar bottles, are made by the pharmacists with the same appearance and characteristics and will be given to our colleague drug distributor in the form of A or B or C. The treatment allocation list is already designed on Block Balanced Randomization Method by the computer software.
1 (A), 2 (B), 3 (B), 4 (B), 5 (A),…….
Any eligible patient will be given a 1 to 90 code after obtaining informed consent in order to visit the clinic and based on above block, they receive A or B or C drug. The drug distributor doesn’t have a role in the treatment plan and data analysis. The patients, researcher, data analyzer are not aware of the type of treatment for each patient. Finally, the patients will be followed by their own codes
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Formulation A, B and C have been administered in the similar bottles, so patients and researchers were unable to detect which one was Myrrh, Boswelia and betadine. Our nurse colleague in this study in Hafez and Zeinabie hospitals delivered formulations to the participants of the study according to the randomized block table. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified.
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Placebo
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Used
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Assignment
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Parallel
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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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2019-02-27, 1397/12/08
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Ethics committee reference number
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IR.SUMS.MED.REC.1398.001
Health conditions studied
1
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Description of health condition studied
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Episiotomy wound healing
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ICD-10 code
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O90.1
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ICD-10 code description
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Disruption of perineal obstetric wound
Primary outcomes
1
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Description
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wound healing
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Timepoint
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The 0, 2 , 7 day after delivery
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Method of measurement
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visiting the paients and filling " REEDA" questionnaire by the researcher
Intervention groups
1
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Description
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Intervention group: Group A will receive herbal formulation based on Myrrh, Hydro alcoholic extract of Myrrh resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice a day for a week.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Group B will receive herbal formulation based on Boswellia, Hydro alcoholic extract of Boswellia resin prepared by 1: 5 ratio (90% ethanol was used). Each patient will use 15 cc in 5 liter of water for 10 minutes, twice daily for a week.
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Category
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Treatment - Drugs
3
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Description
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Control group: Patients in group C will use Betadine solution, 15 cc in 5 liter of water for 10 minutes, twice daily for a week.
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Category
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Treatment - Drugs
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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No
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Title of funding source
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Shiraz University Of medical Science
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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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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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En IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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IPD: 2019 Ethic form: 2019
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To whom data/document is available
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IPD: Researcher & Patient Ethic form: Patient
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Under which criteria data/document could be used
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IPD: Ethic form: Awareness of test results
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From where data/document is obtainable
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IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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IPD: Vice chancellery Ethic form: Vice chancellery
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Comments
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