The aim of this randomized clinical trial study is to determine the effect of perineum warm pad on episiotomy and genital tract trauma rate in nulliparous women.
Inclusion criteria:The mother age between 18_35 years; fetal birth weight in normal range; singleton pregnancy and cephalic presentation; gestational age between 37_42 weeks.The exclusion criteria: creating any contraindication for continuing normal delivery and needing cesarean section and instrumental delivery.The study population includes 114 nulliparous women will be randomly selected as the sample.The case and control groups contain 57 subject each.
In this study there is no any intervention in labour and delivery process in control group but for case group the warm pad is placed on the mothers perineum by trained midwives at the start of second stage of labour.The pad will be removed when the mother is transferred to the delivery room.The researcher which is the delivery agent is unware of setting and unsetting the pad to every one of the mothers.Sampling is continually during 3 months and 3 or 4 times a week.The first sign of research is the effect the warm pad of episiotomy and genital tract trauma rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101519547N1
Registration date:2015-05-17, 1394/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Fatemeh Alihosseini
Name of organization / entity
Ahvaz uni of medical sincese
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 5071
Email address
alihosseini.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2015-03-16, 1393/12/25
Expected recruitment end date
2015-06-15, 1394/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of perineum warm pad in the second stage of labour on episiotomy and genital tract trauma rate
Public title
The effect of perineum warm pad in the second stage of labour on episiotomy and genital tract trauma rate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The mother age 18_35; The gestational age 37_42 weeks; normal fetal birth range 2500_4000gr; singleton pregnancy & cephalic presentation; no any contraindication for normal delivery at the beginning of admission.
Exclusion criteria: Creating any contraindication for continuing normal delivery during study and needing cesarean section; creating any dystotia during delivery; needing instrumental delivery.
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:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University Of Medical Sciences
Street address
Golestan Autobahn
City
Ahvaz
Postal code
61357_15794
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
ajums.rec.1393.186
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Number of episiotomies
Timepoint
After delivery
Method of measurement
Observation and count
2
Description
Number of prineal tears
Timepoint
After delivery
Method of measurement
Observation and count
Secondary outcomes
empty
Intervention groups
1
Description
In case group: using the warm pad during the second stage of labour at the start of which the warm pad is placed on mother perineum.This pad can produce about 45C heat for at most 12 hours.
Category
Prevention
2
Description
In control group: Doing routine cares in the ward without using placebo.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali hospital of Andimeshk
Full name of responsible person
Fatemeh Alihosseini
Street address
Emam َََAli hospital, Emam Ali autoban, Andimeshk, Khoozestan
City
Andimeshk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Naser Saki
Street address
Golestan autobahn, Ahvaz, Khoozestan
City
Ahvaz
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
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
Ahvaz University Of Medical Sciences
Full name of responsible person
Fatemeh Alihosseni
Position
Master degree of midwifery student
Other areas of specialty/work
Street address
Number15, Alavi Avenue, Khorramabad, Lorestan
City
Khorramabad
Postal code
6813965451
Phone
+98 61 3331 3099
Fax
+98 61 3340 6099
Email
alihosseini.f@ajums.ac.ir; aaa_fatemeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University Of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
PHD of Midwifery
Other areas of specialty/work
Street address
Khoozestan
City
Ahvaz
Postal code
613571575794
Phone
+98 61 3336 1984
Fax
+98 61 3336 1984
Email
parvinabedi@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University Of Medical Sciences
Full name of responsible person
Fatemeh Alihosseini
Position
Master degree of midwifery student
Other areas of specialty/work
Street address
Iran, Khoozestan, Ahvaz University Of Medical Sciences
City
Ahvaz
Postal code
613575794
Phone
+98 66 3331 3099
Fax
+98 66 3340 6099
Email
aaa_fatemeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)