This study is a randomized controlled clinical trial that was done in Kamali hospital in Karaj with the participation of 166 nulliparous women in 40-37 weeks of pregnancy who were candidates for vaginal delivery. The samples were randomly divided into two groups, using breathing techniques and routine maneuver (Valsalva maneuver).In control group pushing was done with keeping breath. In the breathing technique The mother was asked with the onset of abdominal pain to inhale two deep abdominal breaths and then exhale with open mouth. During controlled exhale ,they are asked to push for 5-4 seconds and then start the next push again according to the training instruction. In intervention group, pushing continued until crowning stage. After that, mothers were asked to control pushing by using blowing technique until ejection of the neonate head occurred .this process must be carry out only with uterine contractions, without increased abdominal pressure caused by moms excessive pushing. IN routine group, Valsalva maneuver continue until fetal scalp got out. Outcomes of this study include perineal status check, length of second stage of labor, fetal heart condition and the Apgar score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092819310N1
Registration date:2014-10-18, 1393/07/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-18, 1393/07/26
Registrant information
Name
Zohre Ahmadi
Name of organization / entity
Sadughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1720 1995
Email address
zohreahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-09-19, 1393/06/28
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pushing with breathing techniques on perineal statue and delivery outcome in nulliparous in Kamali hospital in Karaj
Public title
Effect of pushing with breathing techniques on perineal statue and delivery outcome in nulliparous in Kamali hospital in Karaj
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : age 18-35; gestational age ≥37 weeks ; Were anticipating a vaginal birth (both normal spontaneous or instrumental) ;normal BMI ;having 6 score or more in vaginal exam according to Brinks score Exclusion criteria :Did not wish to participate ;Had an epidural analgesia ;emergency Cesarean ;fetal birth weight> 3999 gr or<2500 ; head circumference <32cm or>38cm
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:
166
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 committee of Shahid Beheshti university
Street address
Nursing Midwifery Collage; Niayes; Valiaasr AV; Tehran
City
Tehran
Postal code
1985717443
Approval date
2013-09-14, 1392/06/23
Ethics committee reference number
400/4013
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
perineal outcome
Timepoint
as soon as ending delivery
Method of measurement
according to definition of perineal damage
2
Description
apgar
Timepoint
as soon as ending of delivery
Method of measurement
accorging to apgar definition
3
Description
length of second stage of labor
Timepoint
at the end of intervention befor delivery
Method of measurement
hour(minute)
4
Description
abnormal FHR sound
Timepoint
during intervention every 5 minuts
Method of measurement
sony keyd
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group used breathing techniques from completing dilatation until fetus exit this means that with every contraction every muscle in their body starting to relax, by breathing deeply through the nose and blowing abdomen simultaneously .then while the abdominal muscles are contracted, they carry out a deep breath through half open mouth or through nose .after that they take a deep breath again and expiration with all strength over half-open mouth during 5-4 seconds and then after re breathing ,the next force will be started until the contraction ends. At the end of the contraction, two deep abdominal breathing was done (with an open glottis). This trend continued until the head of neonate is going to exit. At this time people took a deep breath and start to blow for 3-2 seconds .
Category
Prevention
2
Description
In control subjects using Valsalva maneuver for pushing in the second stage. This means that initially took a deep breath and hold it for 10 seconds and proceed with straining to have a closed glottis
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Mrs Tahlavi
Street address
Kamali AV, Karaj Alborz
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Ziaee
Street address
MedicalCollage,Kudakyar AV,Evin,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti 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
Shahid Sadughi University of Medical Sciences
Full name of responsible person
Zohre Ahmadi
Position
Student Of Master Of Midwifery
Other areas of specialty/work
Street address
Shahid Sadughi University of Medical Sciences , Nursing & midwifery collage,Buali Street,Yazd
City
Yazd
Postal code
Phone
+98 35 1720 1995
Fax
Email
Ahmadiz77@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnaz Tork Zahrani
Position
Master Of Midwifery
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences ,Nursing&midwifery collage, Valiaasr AV, Tehran
City
Tehran
Postal code
Phone
+98 21 8865 5367
Fax
Email
zahranishahnaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadughi University of Medical Sciences
Full name of responsible person
Zohre Ahmad
Position
Student Of Master Of Midwifery
Other areas of specialty/work
Street address
Shahid Sadughi University of Medical Sciences , Nursing & midwifery collage,Buali Street,Yazd
City
Yazd
Postal code
Phone
+98 35 1720 1995
Fax
Email
ahmadiz77@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)