The effect of warm compress bi-stage intervention on prevention of perineal trauma and second stage pain intensity and duration the first stage and second stage in primiparous with delayed valsalva maneuver referred to selected hospital of Shiraz university of medical sciences 2012
This study is a randomized clinical trial on 255 women referred to the maternity hospital in Shiraz University of Medical Sciences and considering the effect of warm compress bi-stage intervention on prevention of perineal trauma and second stage pain intensity and duration the first stage and second stage in primiparous with delayed valsalva maneuver. After obtaining informed consent, the eligible women were randomly allocated into three groups (two experimental groups and one control group). In three groups to measure the second stage of labor pain using the McGill Pain ruler was used and valsalva maneuver to decrease until there is a feeling of straining itself, was postponed. In two groups, warm compresses between 15-20 minutes and during contractions were laid on perineal. Groups with a single step, after entering the second stage of labor (dilation 10 centimeters and a zero position) were put warm compresses on the perineum. The two-stage intervention group, a warm compress on the dilatation of 7-8 cm and a lateral dilatation of 10 cm was placed on the perineum. The control group received only routine care. All samples were delivered in position lithotomy position. Postpartum (Stage IV) in all three groups already prepared a questionnaire to determine the action episiotomy, perineal intact, rupture length, rupture area, was completed. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051511706N7
Registration date:2014-05-17, 1393/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-17, 1393/02/27
Registrant information
Name
Zahra Masoudi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7282
Email address
masoudi_z@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Shiraz University of Medical Sciences
Expected recruitment start date
2012-10-11, 1391/07/20
Expected recruitment end date
2013-01-09, 1391/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of warm compress bi-stage intervention on prevention of perineal trauma and second stage pain intensity and duration the first stage and second stage in primiparous with delayed valsalva maneuver referred to selected hospital of Shiraz university of medical sciences 2012
Public title
The effect of warm compress bi-stage intervention on prevention of perineal trauma and second stage pain intensity and duration the first stage and second stage in primiparous with delayed valsalva maneuver
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: primiparous; single and term pregnancy; vertex presentation; lack of hip tightness; no previous exposure to any type of medical condition; no preeclampsia; mother’s age 18-35 years old; Hb≥11; lack of any lesion in the perineum and vagina; 2000-3500 gr birth weight; anterior oxypot; not using local anesthesia and analgesia techniques such as gas Entonox; no method of perineal massage during pregnancy.The exclusion criteria: any condition requiring induction of labor or cesarean section, such as placental abruption, meconium, fetal distress in the first and second stage; the use of forceps or vacuum extraction; prolonged second stage more than 2 hours.
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:
225
Randomization (investigator's opinion)
Randomized
Randomization description
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 in Medical Research, Shiraz University of Medical Sciences
Street address
Deputy of Research_Floor 7_University of Medical Sciences of Central Building_Zand Avenue_Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2012-08-31, 1391/06/10
Ethics committee reference number
CT_P_6272
Health conditions studied
1
Description of health condition studied
Pain intensity
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain
2
Description of health condition studied
Perineal laceration
ICD-10 code
O70
ICD-10 code description
Perineal laceration during delivery
Primary outcomes
1
Description
Second stage of labor pain
Timepoint
After delivery
Method of measurement
McGill Pain ruler
2
Description
Perineal laceration size
Timepoint
After delivery
Method of measurement
Sterile meter
Secondary outcomes
empty
Intervention groups
1
Description
Groups with a single step, after entering the second stage of labor (dilation 10 centimeters and a zero position) were put warm compresses for 20-15 minutes in between and during contractions on the perineum.
Category
Other
2
Description
The two-stage intervention group, a warm compress on the cervix dilatation 8-7 cm and a 10 cm between and during contractions lasting 20-15 minutes on the perineum was placed.
Category
Other
3
Description
The control group received only routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shushtari Hospital
Full name of responsible person
Andishe Jorkesh
Street address
Corner Regiment - Shushtari Hospital
City
Shiraz
2
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Dr Marya Yazdani
Street address
Beginning Chamran Boulevard
City
Shiraz
3
Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Mahboobe Hatam
Street address
Ghods squear
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Research_seven floors_University of Central Building_ near red crescent_ zand avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Faride Vaziri
Position
Master of Midwifery, Faculty Member
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School Of Nursing & Midwifery, Namazi squear, Shiraz.
City
Shiraz
Postal code
713451978
Phone
+98 71 1647 4252
Fax
Email
Roose82003@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Master of Midwifery, Faculty Member
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School Of Nursing & Midwifery, Namazi squear, Shiraz.
City
Shiraz
Postal code
713451978
Phone
+98 71 1647 4252
Fax
Email
Akbarzadehmarzieh@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Univesity Of Medical Science
Full name of responsible person
Zahra Masoudi
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School Of Nursing & Midwifery, Namazi squear, Shiraz.