Protocol summary
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Study aim
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The effect of lubricant gel during the first phase of labor on labor stages and perineal health.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Length of delivery stage; Perineum status
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160418027464N2
Registration date:
2019-03-12, 1397/12/21
Registration timing:
prospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2019-03-12, 1397/12/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-14, 1397/12/23
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Expected recruitment end date
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2019-05-22, 1398/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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Effect of Lubricant gel on labor consequences.
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A sealed package containing dedicated interventions will be created based on a randomization list for each patient.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The data analyzer will not be aware of the data codes.
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-02-29, 1394/12/10
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Ethics committee reference number
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IR.IRSHUMS.REC.1394.9
Health conditions studied
1
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Description of health condition studied
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outcome of delivery
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The length of the first stage of labor
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Timepoint
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Determine the length of delivery stages after intervention
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Method of measurement
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Clock
2
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Description
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Perineum status
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Timepoint
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The examination of the condition of the perineum will be performed after the end of the third stage of labor.
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Method of measurement
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Investigating the condition of the perinea by the researcher.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: In the control group, routine care will be provided.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iranshahr University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Sharing will be in the form of the article.
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When the data will become available and for how long
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One year after the end of the plan.
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To whom data/document is available
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Only available to scholars working in academic and academic institutions.
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Under which criteria data/document could be used
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It will be possible to use the data by sending the email to the responsible author.
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From where data/document is obtainable
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Corresponding to the author of the article.
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What processes are involved for a request to access data/document
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After sending the email to the responsible author, it will be answered within a week.
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Comments
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Use of data will only be possible in academic approved schemes.