Evaluation of effect of teueriumpolium and aloe vera gel on episiotomy wound healing
Design
This is a one blinded randomized clinical trial, in which at least 50 eligible patients will be randomly assigned to the intervention and control groups.
Settings and conduct
The eligible women who delivered and will refer to Khalijfars Hospital , Bandar-abbas during the study period will be enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 35 years; Gestational age of 35 weeks or higher; Medio lateral incision and 2nd degree episiotomy; Normal body mass index; Primiparous Exclusion criteria: Cigarette smoking; Condiloma lesions or herpes in perinea; Preeclampsia; Diabetes; Coagulopathy; Cardiovascular diseases; Renal failure
Intervention groups
Intervention group: Teueriumpolium and aloe vera gel twice on location of episiotomy wound for 10 days
Control group: Placebo gel twice on location of episiotomy wound for 10 days
Main outcome variables
Primary outcome: Episiotomy wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N9
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-20, 1399/07/29
Expected recruitment end date
2020-12-19, 1399/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of teueriumpolium and aloe vera gel on episiotomy wound healing in primiparous women
Public title
Teueriumpolium and aloe vera gel on episiotomy wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years
Gestational age 37 weeks and above
Medio lateral incision and 2nd degree episiotomy
Normal body mass index
Primiparous
Exclusion criteria:
Cigarette smoking
Condiloma lesions or herpes in perinea
Preeclampsia
Diabetes
Coagulopathy
Cardiovascular diseases
Renal failure
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A and B) for the allocation of subjects to intervention (A) and control (B) groups will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The one-way blindness of this study means that the patient did not know the type of treatment prescribed and the shape, size, and color of the gel in the intervention group were similar to the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Approval date
2020-10-19, 1399/07/28
Ethics committee reference number
IR.HUMS.REC.1399.371
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Episiotomy wound healing
Timepoint
5 and 10 days after intervention
Method of measurement
REEDA questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teueriumpolium and aloe vera gel twice on location of episiotomy wound for 10 days.Each 30 grams of gel contains 6% of teueriumpolium extract and 15% of aloe vera extract.This gel is made in the laboratory of Yasuj Medicinal Plants Research Center, Iran.
Category
Treatment - Drugs
2
Description
Control group: Placebo gel twice on location of episiotomy wound for 10 days.This gel is made in the laboratory of Yasuj Medicinal Plants Research Center, Iran.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Street address
Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6365
Email
maryamazizikut86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymoor Aghamolaei
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
+98 76 3333 7192
Phone
+98 76 3333 7192
Email
maryamazizikut86@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
City
Bandarabbas
Province
Hormozgan
Postal code
7916839319
Phone
076333666365
Email
maryamazizikut86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD