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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General information
110
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2016-02-20, 1394/12/01
2019-03-14, 1397/12/23
20162019-0203-2014 00:00:00
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Recruitment centers
#1
Name of recruitment center - English: Maternity Hospital of Iran Iran Hospital
Name of recruitment center - Persian: زایشگاه بیمارستان ایران ایرانشهر
Full name of responsible person - English: Fatemeh Azarkish
Full name of responsible person - Persian: فاطمه آذرکیش
Street address - English: Balouch
Street address - Persian: خیابان بلوچ
City - English: Iranshahr
City - Persian: ایرانشهر
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: ۷۶۱۸۸۱۵۶۷۶
Phone: +98 54 3721 3328
Fax: +98 54 3721 3328
Email: Azarkish2005@yahoo.com
Web page address:
Name of recruitment center - English: Maternity hospital of Iran, Iranshahr
Name of recruitment center - Persian: زایشگاه بیمارستان ایران، ایرانشهر
Full name of responsible person - English: Fatemeh Azarkish
Full name of responsible person - Persian: فاطمه آذرکیش
Street address - English: Education and Research Management part, Deputy Director of Education and Research, Balouch street
Street address - Persian: خیابان بلوچ , معاونت آموزش و تحقیقات ،مدیریت آموزش و تحقیقات
City - English: Iranshahr
City - Persian: ایرانشهر
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: ۷۶۱۸۸۱۵۶۷۶
Phone: +98 54 3721 3328
Fax: +98 54 3721 3328
Email: Azarkish2005@yahoo.com
Web page address:
Name of recruitment center - English: Maternity Hospitalhospital of Iran Iran Hospital, Iranshahr Name of recruitment center - Persian: زایشگاه بیمارستان ایران، ایرانشهر Full name of responsible person - English: Fatemeh Azarkish Full name of responsible person - Persian: فاطمه آذرکیش Street address - English: Education and Research Management part, Deputy Director of Education and Research, Balouch street Street address - Persian: خیابان بلوچ , معاونت آموزش و تحقیقات ،مدیریت آموزش و تحقیقات City - English: Iranshahr City - Persian: ایرانشهر Province: Sistan-va-Balouchestan Country: Iran (Islamic Republic of) Postal code: ۷۶۱۸۸۱۵۶۷۶ Phone: +98 54 3721 3328 Fax: +98 54 3721 3328 Email: Azarkish2005@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: معاونت تحقیقات دانشگاه
Full name of responsible person - Persian: University Research Dept.
Street address - English: Balouch
Street address - Persian: بلوچ
City - English: Iranshahr
City - Persian: ایرانشهر
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: ۷۶۱۸۸۱۵۶۷۶
Phone: +98 54 3721 0485
Fax: +98 54 3721 0485
Email: tahminehsalehian@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Fatemeh Azarkish
Full name of responsible person - Persian: دکتر فاطمه آذرکیش
Street address - English: Education Management part, Baloch Street, Iranshahr.
Street address - Persian: ایرانشهر ، خیابان بلوچ ،مدیریت آموزش.
City - English: Iranshahr
City - Persian: ایرانشهر
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: ۷۶۱۸۸۱۵۶۷۶
Phone: +98 54 3721 0485
Fax: +98 54 3721 0485
Email: tahminehsalehian@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: معاونت تحقیقات دانشگاهDr Fatemeh Azarkish Full name of responsible person - Persian: University Research Dept.دکتر فاطمه آذرکیش Street address - English: BalouchEducation Management part, Baloch Street, Iranshahr. Street address - Persian: ایرانشهر ، خیابان بلوچ ،مدیریت آموزش. City - English: Iranshahr City - Persian: ایرانشهر Province: Sistan-va-Balouchestan Country: Iran (Islamic Republic of) Postal code: ۷۶۱۸۸۱۵۶۷۶ Phone: +98 54 3721 0485 Fax: +98 54 3721 0485 Email: tahminehsalehian@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fatemeh Azarkish
Full name of responsible person - Persian: فاطمه آذرکیش
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Balouch
Street address - Persian: بلوچ
City - English: Iranshahr
City - Persian: فارسی
Province: Sistan-va-Balouchestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۷۶۱۸۸۱۵۶۷۶
Phone: +98 37210485
Mobile: +98 915 547 4967
Fax:
Email: Azarkish2005@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fatemeh Azarkish
Full name of responsible person - Persian: فاطمه آذرکیش
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 53
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Balouch
Street address - Persian: بلوچ
City - English: Iranshahr
City - Persian: فارسی
Province: Sistan-va-Balouchestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۷۶۱۸۸۱۵۶۷۶
Phone: +98 37210485
Mobile: +98 915 547 4967
Fax:
Email: Azarkish2005@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Fatemeh Azarkish Full name of responsible person - Persian: فاطمه آذرکیش Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 4953 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Balouch Street address - Persian: بلوچ City - English: Iranshahr City - Persian: فارسی Province: Sistan-va-Balouchestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۷۶۱۸۸۱۵۶۷۶ Phone: +98 37210485 Mobile: +98 915 547 4967 Fax: Email: Azarkish2005@yahoo.com Web page address:
Protocol summary
Study aim
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:prospective
Last update:2019-09-15, 1398/06/24
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
2019-03-14, 1397/12/23
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
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, Iranshahr
Full name of responsible person
Fatemeh Azarkish
Street address
Education and Research Management part, Deputy Director of Education and Research, Balouch street