The effect of lubricating vaginal with natural animal fat on the second stage of labor, frequency of episiotomy and preineal laceration in primiparous women
The effect of lubricating vaginal with natural animal fat on the second stage of labor, frequency of episiotomy and preineal laceration in primiparous women
Design
The study is a clinical trial performed 129 people and groups of 43 people, two intervention and one control groups.
Settings and conduct
The study was conducted 0n population referred to Shahid Beheshti hospital in Abadan ; these patents were first evaluated by demographic and fertility questionnaire and voluntarily entered the study. Subjects were given a duck fat and lubricant gel and the control group did not receive medication.
Participants/Inclusion and exclusion criteria
include criteria:
Age 18-35 years, singleton and nulliparous pregnancy, gestational age 37-42 weeks according to ultrasound of the first 3 months of pregnancy or LMP, cephalic presentation, perineal length 3-5 cm
uninclud criteria:
High fever, Prolonged rupture of the amniotic sac, abruption, FHR drop, Vaginal bleeding, percipeptid delivery, OP position, Contraindications to normal delivery and episiotomy, Vaginal infections and genital herpes, Chronic maternal disease
Intervention groups
Two intervention groups, one group intake duck oil and the other group intake lubricant in the second phase of labor
Control group without medication.
Main outcome variables
Time The second stage of labor; episiotomy; Perineal laceration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200721048154N1
Registration date:2020-08-24, 1399/06/03
Registration timing:retrospective
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Mona Matori abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5332 9401
Email address
mona.2017.sh00@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-07-19, 1399/04/29
Actual recruitment start date
2020-03-24, 1399/01/05
Actual recruitment end date
2020-07-17, 1399/04/27
Trial completion date
2020-07-17, 1399/04/27
Scientific title
The effect of lubricating vaginal with natural animal fat on the second stage of labor, frequency of episiotomy and preineal laceration in primiparous women
Public title
The effect of lubricating vaginal with natural animal fat on the second stage of labor, frequency of episiotomy and preineal laceration in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-35 years
single and primiparous pregnancy
Gestational age 37-42 weeks according to ultrasound of the first 3 months of pregnancy or last menstrual period
Cephalic presentation
Perineal length 5-3 cm
Exclusion criteria:
Occurrence of any obstetric complication including high fever, prolonged rupture of the membranes,placental abruption, decreased FHR, vaginal bleeding, and complications that endanger the health of the mother or her baby.
participated delivery.
Posterior occipital position.
Contraindications to natural vaginal delivery and episiotomy.
Vaginal infections and genital herpes and chronic disease in the mother.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
129
Actual sample size reached:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method and using a table of random numbers in such a way that in case of unit number 1-2-3 samples in the control group, 4-5-6 samples in the intervention group 1 (gel), 7-8-9 samples in the group Intervention 2 (oil)
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants after admission to the hospital and having all the inclusion criteria after completing the informed consent form are completely randomly placed in one of the control groups, intervention 1 (gel), intervention 2 (oil) and participants are unaware of the allocation of study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
No.415/6, Nine Bahar street, Abadan
City
Abadan
Province
Khouzestan
Postal code
6317843764
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.AJUMS.REC.1399.304
Health conditions studied
1
Description of health condition studied
Duration of the second stage of labor and birth canal injuries
ICD-10 code
O94
ICD-10 code description
sequelae of complication of pregnancy childbirth and the puerperium
Primary outcomes
1
Description
Time of The second stage of labor
Timepoint
The second phase of labor
Method of measurement
The length of the second stage of labor will be measured through a researcher-made questionnaire.
2
Description
Episiotomy
Timepoint
The fourth stage of labor
Method of measurement
recorded through a researcher-made questionnaire during delivery.
3
Description
Perineal laceration
Timepoint
The fourth stage of labor
Method of measurement
recorded through a researcher-made questionnaire during delivery.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (gel): The intervention in the intervention group will be performed during labor after dilation is complete. During the second stage of labor, after wearing sterile gloves by the midwife, gently massage with two index and middle fingers impregnated with lubricant gel purchased from Razak Laboratories in the amount of 5 ml from one wall to another wall of the vagina (in the form of movement and Return (letter U) will be done by gently pushing the rectum up and down so that each part lasts at least a minute. The massage will continue during and between pushing the mother.
Category
Treatment - Drugs
2
Description
Group 2 Intervention (oil): The intervention in the intervention group will be performed during labor after dilatation is complete. During the second stage of labor, after wearing sterile gloves by a midwife, gently massage with two index and middle fingers dipped in duck tallow oil, from one wall to another wall of the vagina (in the form of a reciprocating motion, the letter U in English) with pressure. Gently move up and down the rectum so that each part lasts at least a minute. The massage will continue during and between pushing the mother. The intervention group will be given a perineal massage with tallow for 5-10 minutes.
Category
Treatment - Drugs
3
Description
Control group: The control group will receive non-drug massage and routine care during hospitalization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Abadan
Full name of responsible person
Mojgan Javad Nouri
Street address
N0.415/6,Nine Bahar street, Abadan
City
Ahvaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5332 9401
Email
Javadnoori-m@ajoms.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Muhammad Bedoui
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5332 9401
Email
badvi-m@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
Mona Matori Abdollahi
Position
Master student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.415/6,Nine Bahar street, Abadan
City
Ahwaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5332 9401
Email
Mona.2017.sh00@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
dr.Mojgan Javadnoori
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5332 9401
Email
Javadnoori-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mona Matori Abdollahi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.415/6, Nine Bahar street, Abadan
City
Ahvaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5332 9401
Email
Mona.2017.sh00@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