1. Determining and comparing the amount of pain and episiotomy wound healing before intervention and in the first 24 hours after delivery and on days 5 and 10 postpartum in Malva sylvestris L extract ointment and placebo ointment group with Each other.
2. Determine the side effects of consuming Malva sylvestris L ointment.
Design
A clinical trial with control group, with parallel groups, triple blind, randomization using random allocation software. Phase three Trial and The sample size is 112 people.
Settings and conduct
This research is a kind of three-blind clinical trial that will be conducted in Mahdiyeh hospital in Tehran. The ointments of Malva-sylvestris-L extract and placebo are made with the same packaging and with different codes that the pharmacist will be aware of. The researcher, the patient and the statistics do not know the contents of the drugs. The participants will randomly choose one of the coded cards according to the drug code and will be placed in one of the two intervention or control groups. The ointments will be used twice a day for 10 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous women giving birth; Ages 18 to 35 years; Being Iranian; Gestational age between 37 and 42 weeks; Having single fetal cephalic presentation.
Exclusion criteria: Amniotic sac rupture more than 24 hours; Having hematoma; fever and puerperal infection after delivery
Intervention groups
Intervention group: Malva sylvestris L 3% ointment is applied Twice daily, 2 centimeters (cm), for 10 days on episiotomy ulcer.
Control group: Placebo ointment Twice daily, 2 cm, is applied on episiotomy ulcer for 10 days.
Initial assessment of pain intensity and wound healing is done 24 hours after the intervention and then on the 5th and 10th days.
Main outcome variables
Pain; Redness; Edema; Ecchymosis; Discharge from the wound; Approximation of the perineal tissue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100130003226N19
Registration date:2022-11-28, 1401/09/07
Registration timing:prospective
Last update:2022-11-28, 1401/09/07
Update count:0
Registration date
2022-11-28, 1401/09/07
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Malva sylvestris L extract ointment and placebo on pain intensity and episiotomy wound healing in primiparous women
Public title
Evaluation the effect of Malva sylvestris L extract ointment on pain intensity and incision of during delivery wound healing in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 18 to 35 years primiparous
Being Iranian
Gestational age between 37 to 42 weeks
No smoking, alcohol and drugs
Being literate in reading and writing
Having a single fetus with cephalic presentation
Fetal weight between 2500 and 4000 gr
Body Mass Index (BMI) between 18.5 and 25
Vaginal delivery with mediolateral episiotomy
The normality of the first, second and third stages of labor
Exclusion criteria:
Amniotic sac rupture more than 24 hours
Allergy to Malva sylvestris L ointment
Having fever, puerperal infection and hematoma
Infant hospitalization at Neonatal Intensive Care Unit
Having postpartum hemorrhoids or fissures
Having sex in the first ten days after delivery
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
It is available (simple) and goal based. In this way, all patients who are eligible for the study will be screened. The delivery of medicine to the patients in a box containing several cards that are evenly written in the English alphabet "A and B" with the placebo and Malva sylvestris L ointment code (researcher unaware of the content of the ointments) we match and patients randomly choose a card and receive the medicine according to the letters on the card.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a kind of triple-blind randomized controlled clinical trial. At the diagnostic stage, the demographic forms and obstetric and delivery questionnaire are not completed and the patient's name is not written. At the stage of giving medicine to the patient, a placebo and Malva-sylvestris-L ointment are marked with the English letter A and B coded by the pharmacist. The researcher is not aware of the contents of the ointments and the patient also randomly selects one of the placeboes or Malva-sylvestris-L ointments the statistic professor is also unaware of the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Pharmacy, Nursing and Midwifery Faculties of Shahid Beheshti University of Medic
Street address
Block A, 13th floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, between South Flamak and Zarafshan, Quds Town (West), Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.160
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O70
ICD-10 code description
Perineal laceration during delivery
Primary outcomes
1
Description
Episiotomy wound healing
Timepoint
Before the intervention, the first 24 hours, 5 and 10 days after treatment
Method of measurement
REEDA scale assess 5 items such as Redness, Edema, Ecchymoses, Discharge from the wound and Approximation of the perineal tissues.
2
Description
Episiotomy wound pain intensity
Timepoint
Before the intervention, the first 24 hours, 5 and 10 days after treatment
Method of measurement
The visual pain scale (VAS) is a tool for measuring the intensity of pain, which is a 10 cm ruler with eleven numbers.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Uses 3% Malva sylvestris L ointment for 10 days (daily) at a rate of two centimeters, on episiotomy wound. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of pain intensity and wound healing is done before the intervention, 24 hours after the intervention and then on the fifth and tenth days.
Category
Treatment - Drugs
2
Description
Control group: Control group: Use placebo ointment (quite similar to Malva sylvestris L ointment) for 2 days (daily) at 2 cm, on episiotomy ulcer. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of pain intensity and wound healing is done before the intervention, 24 hours after the intervention and then on the fifth and tenth days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh hospital
Full name of responsible person
Zohreh Jafari
Street address
Shahid Rajab Nia St., Shihgar Khane Alley, Shoush Square, Fedaiyan Islam St., Tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Afshin Zarghi
Street address
University Building No. 2 of ShahidBeheshti University of Medical Sciences, Parvaneh Str., Yemeni Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Gynecology Department, In front of Shaheed Rajaee Heart Hospital, The intersection of Niayesh, Vali asr street, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
mhdolatian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahrokh Dolatian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
mhdolatian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Jafari
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Intersection, Valiasr St, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
zohre.jafari76@gmail.com
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