Effect of using the lubricant gel during the active phase of the first stage of the labor on the length of delivery and perineal trauma in primiparous women.
The effect of lubricant gel during the first phase of labor on labor stages and perineal health.
Design
Randomization will be done using a random number table.The sample size will be 55 in each group.The clinical trial will include a control group.
Settings and conduct
The research will be about the use of the Lubricant Gel.The site of this clinical trial will be Maternity ward at Iran Hospital affiliated by Iranshahr University of Medical Sciences.Blindness will only be for data analytics.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
mother age will be 18-35 years old; Single pregnancy; Cephalic presentation; being at gestational age of 42-37 weeks.
Exclusion criteria:
rupture of amniotic membrane; Suspected of embryonic anomalies; Suspected of cephalopelvic disproportion; Maternal diseases; History of surgery on the uterus; Twin pregnancy; Preterm labor.
Intervention groups
In the experimental group, 5 ml of water-soluble lubricant gel is used at each vaginal examination.In the control group, routine actions are performed.
Main outcome variables
Length of delivery stage; Perineum status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160418027464N2
Registration date:2019-03-12, 1397/12/21
Registration timing:registered_while_recruiting
Last update:2019-03-12, 1397/12/21
Update count:1
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 37212968054
Email address
dr.azarkish@irshums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using the lubricant gel during the active phase of the first stage of the labor on the length of delivery and perineal trauma in primiparous women.
Public title
Effect of Lubricant gel on labor consequences.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Primary Porous
Single pregnancy
Cephalic Presentation
- Gestational Age 42-37 weeks
Active phase of labor.
Exclusion criteria:
Symptoms of Amniotic fluid Infection
Symptoms of Respiratory Distress
Long-term rupture of amniotic fluid
Fetal abnormality
Cephalopelvic Disproportion
Surgery on uterus
Preterm pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
A sealed package containing dedicated interventions will be created based on a randomization list for each patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not be aware of the data codes.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iranshahr University of Medical Sciences
Street address
Balouch Street
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۹۹۱۶۶۴۳۵۳۵
Approval date
2016-02-29, 1394/12/10
Ethics committee reference number
IR.IRSHUMS.REC.1394.9
Health conditions studied
1
Description of health condition studied
outcome of delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The length of the first stage of labor
Timepoint
Determine the length of delivery stages after intervention
Method of measurement
Clock
2
Description
Perineum status
Timepoint
The examination of the condition of the perineum will be performed after the end of the third stage of labor.
Method of measurement
Investigating the condition of the perinea by the researcher.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, from the time of the 4 cm dilatation of the cervix to the second stage of delivery, 5 ml of water-soluble Lubricant gel produced by Shafa company will be used at each vaginal examination.
Category
Treatment - Other
2
Description
Control group: In the control group, routine care will be provided.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity Hospital of Iran Iran Hospital
Full name of responsible person
Fatemeh Azarkish
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3721 3328
Fax
+98 54 3721 3328
Email
Azarkish2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
معاونت تحقیقات دانشگاه
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3721 0485
Fax
+98 54 3721 0485
Email
tahminehsalehian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr 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
Iranshahr University of Medical Sciences
Full name of responsible person
Fatemeh Azarkish
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 37210485
Fax
Email
Azarkish2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Fatemeh Azarkish
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3721 3328
Fax
+98 54 3721 3328
Email
Azarkish2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Fatemeh Azarkish
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Balouch
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۷۶۱۸۸۱۵۶۷۶
Phone
+98 54 3721 3328
Fax
+98 54 3721 3328
Email
Azarkish2005@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Sharing will be in the form of the article.
When the data will become available and for how long
One year after the end of the plan.
To whom data/document is available
Only available to scholars working in academic and academic institutions.
Under which criteria data/document could be used
It will be possible to use the data by sending the email to the responsible author.
From where data/document is obtainable
Corresponding to the author of the article.
What processes are involved for a request to access data/document
After sending the email to the responsible author, it will be answered within a week.
Comments
Use of data will only be possible in academic approved schemes.