Investigating the effect of quince seed mucilage on perineal pain and healing following episiotomy: a randomized, double-blind, placebo-controlled study
Determining the effect of quince seed mucilage on perineal pain and healing following episiotomy
Design
A double-blinded, randomized, placebo controlled clinical trial with parallel groups
Settings and conduct
This study is a double-blinded clinical trial that will be conducted in Motazedi Hospital affiliated to Kermanshah University of Medical Science. The prepared cream and placebo are made in a similar package with a different code that the pharmacist will be aware of.Patients are also coded according to the blocking method and the ointment will be given in two coded groups.
Participants/Inclusion and exclusion criteria
Entry requirements: Primigravida women with episiotomy, cephalic presentation and term pregnancy.
Non-entry conditions: Difficult delivery, severe postpartum hemorrhage and occurrence of any side effects during the intervention.
Intervention groups
Intervention group 1 (seed to mucilage group): people in this group will use quince seed mucilage at the episiotomy site for 14 days.
Intervention group 2 (control group): People in this group will use placebo at the episiotomy site for 14 days.
Main outcome variables
Perineal pain and healing following episiotomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027633N9
Registration date:2023-08-05, 1402/05/14
Registration timing:prospective
Last update:2023-08-05, 1402/05/14
Update count:0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Foruzan Sharifipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
f.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of quince seed mucilage on perineal pain and healing following episiotomy: a randomized, double-blind, placebo-controlled study
Public title
Investigating the effect of quince seed mucilage on perineal pain and healing following episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy
Vertex presentation
Single and term pregnancy
The normal body mass index of the mother is between 19.5 and 24.9
Uncomplicated delivery
Mediolateral episiotomy
Willingness to cooperate
Exclusion criteria:
Dystocia
Use of instrumental delivery
Third and fourth degree perineal tears
Any disease in mother and newborn
Withdrawal of participants during the study
Sever postpartum hemorrhage
Any lesion or skin infection in the perineum
Occurrence of any side effects during the intervention
Use of other herbal or medical creams to heal the episiotomy during the intervention
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The mothers will be randomly assigned in to 2groups in order to Block random allocation method with block size of 4, and ratio of 1:1. It works by randomizing participants within blocks such that an equal number are assigned to each treatment. This will be done with Epi Info™6.0 software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The quince seed mucilage and placebo are coded in the same shape and size in two tubes so that only the pharmacist will be aware of the tube content. The researcher, clinical evaluator and statisticians will not be aware of this coding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd., Central Building of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.KUMS.REC.1402.156
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
Perineal pain
Timepoint
1, 7 and 14 days after delivery
Method of measurement
VAS pain visual analog scale
Secondary outcomes
1
Description
Episiotomy site healing
Timepoint
1, 7 and 14 days after delivery
Method of measurement
Rida scale
Intervention groups
1
Description
Intervention group: quince seed mucilage . After mucilage preparation by the pharmacist, researcher and research assistant attends Motazedi Hospital maternity ward. Inclusion criteria will be entered into the study after obtaining written consent. Primiparous women undergoing mediolateral episiotomy will be selected and randomly divided in to two groups: placebo and mucilage and will be coded. Perinatal hygiene training will then be given to all two groups and they will be asked to apply the drug three times daily after rinsing with water and continue for up to 14 days. During this time, the researcher calls to participants by telephone and will be excluded if the drug is not used properly or if complications occur. Then the perineum healing and pain will be examined in the first, seventh, and fourteenth days of peurperium at Razi Hospital in Ahvaz. The VAS and REEDA criteria will be evaluated.
Category
Treatment - Drugs
2
Description
Control group: Placebo. The action is according to the intervention group. The gel formulation used in the placebo group (placebo gel) has all the characteristics of the medicinal gel of quince seed mucilage in terms of the components of the formulation (minus the active ingredient of quince seed mucilage). It contains different proportions of carbomer 934P, ethylene glycol and ethanol. After the preparation of the placebo by the pharmacist, the researcher and the research assistant attended the maternity ward of Motazadi Hospital and asked the eligible women to apply it three times a day after washing the perineum with lukewarm water and continue this for 14 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazadi Hospital
Full name of responsible person
Foruzan Sharifipour
Street address
Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
67188 14474
Phone
+98 83 3724 6351
Email
sharifipour_fr91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sirus Jalili
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Fax
+98 83 3838 6835
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?