Comparison of perineal massage during pregnancy and childbirth on the incidence of episiotomy and perineal injuries in nulliparous women
Design
A clinical trial with a control group, with parallel groups, randomized groups, will use the rand function of Excel software for randomization.
Settings and conduct
Samples will be selected in Sina Ahvaz clinic based on the entry criteria and will receive perineal massage in the pregnancy massage group from 34-36 weeks of pregnancy until the time of delivery, and the delivery massage group will receive perineal massage in Labor. The control group will receive only routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nulliparous women 34 to 36 week
Exclusion criteria: Women who are contraindication to natural delivery.
Intervention groups
Intervention group 1: Perineal massage from 34-36 week of pregnancy until delivery.
Intervention group 2: perineal massage during labor.
Control group: routine care.
Main outcome variables
Episiotomy and laceration rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240705062332N2
Registration date:2024-08-17, 1403/05/27
Registration timing:prospective
Last update:2024-08-17, 1403/05/27
Update count:0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
Nila Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4356 7119
Email address
norouzi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-25, 1403/06/04
Expected recruitment end date
2024-10-25, 1403/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of perineal massage in pregnancy and delivery on episiotomy and perineal injuries in nulliparous women
Public title
Comparing the effect of perineal massage in pregnancy and delivery on episiotomy and perineal injuries in nulliparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous women aged 18 to 35
Low risk pregnancy
Gestational age 34 to 36 weeks
Singleton pregnancy
Cephalic presentation
Exclusion criteria:
Premature rupture of membrane
Contraindications to natural vaginal delivery
Vaginal bleeding
Macrosomia according to the last ultrasound
History of surgery in the perineum and anus
Lesions of the vulva area such as leukoplakia, varicose veins
Vaginal infection or genital herpes
Forceps or vacuum delivery
Abnormal presentation
Post-term pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using rand function of Excel software. Sealed opaque envelopes will be labeled from 1 to 180 in order. Each envelope will contain a white paper labeled 'A' for the pregnancy massage group or 'B' for the labor massage group or 'C' for the control group based on randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur Ahvaz University of Medical Sciences
Street address
Vice-Chancellor for Research and Information Technology, Jundishapur University of Ahvaz Medical Sciences, Academic City, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-08-10, 1403/05/20
Ethics committee reference number
IR.AJUMS.REC.1403.230
Health conditions studied
1
Description of health condition studied
Episiotomy in nulliparous women
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
2
Description of health condition studied
First degree perineal laceration
ICD-10 code
O70.0
ICD-10 code description
First degree perineal laceration during delivery
3
Description of health condition studied
Second degree perineal laceration
ICD-10 code
O70.1
ICD-10 code description
Second degree perineal laceration during delivery
4
Description of health condition studied
Third degree perineal laceration
ICD-10 code
O70.2
ICD-10 code description
Third degree perineal laceration during delivery
5
Description of health condition studied
Fourth degree perineal laceration
ICD-10 code
O70.3
ICD-10 code description
Fourth degree perineal laceration during delivery
Primary outcomes
1
Description
Episiotomy rate
Timepoint
During delivery
Method of measurement
Observation
2
Description
First degree perineal laceration rate
Timepoint
After delivery
Method of measurement
Observation
3
Description
Second degree perineal laceration rate
Timepoint
After delivery
Method of measurement
Observation
4
Description
Third degree perineal laceration rate
Timepoint
After delivery
Method of measurement
Observation
5
Description
Fourth degree perineal laceration rate
Timepoint
After delivery
Method of measurement
Observation
Secondary outcomes
1
Description
Bleeding rate
Timepoint
After delivery
Method of measurement
CC (Number of blood gases)
Intervention groups
1
Description
Intervention group 1: Perineal massage in pregnancy
Category
Prevention
2
Description
Intervention group 2: Perineal massage during delivery
Category
Prevention
3
Description
Control group: Routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Sina hospital
Full name of responsible person
Nila Norouzi
Street address
Imam Ali Square, Kut Abdullah, End of Ayatollah Behbahani Highway
City
Ahvaz
Province
Khouzestan
Postal code
6199117111
Phone
+98 61 3555 0592
Email
sinahospital.ch@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakir Kish
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 1984
Email
itc@ajums.ac.ir
Web page address
http://behsan.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nila Norouzi
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8396
Email
Nilanorouzi2878@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tedayon Najaf Abadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8396
Email
tadayon-@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nila Norouzi
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 71 4356 7119
Email
Nilanorouzi2878@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