ABSTRACT:
Background and Aim:
The Valsalva pushing technique is used routinely in the second stage of labor in many countries, and it is accepted as standard obstetric management in Iran. The purpose of this study was to determine the effects of Spontaneous pushing versus Valsalva pushing technique in Birth on outcome of delivery in primiparous in Iran hospital in 2009.
Methods: A randomized controlled trial was conducted on One hundred low-risk primiparas between 38 and 42 weeks’ gestation, who expected a spontaneous vaginal delivery, were randomized to either a spontaneous pushing group or a Valsalva-type pushing group. Spontaneous pushing women were informed about spontaneous pushing technique (open glottis pushing while breathing out) and were supported in pushing spontaneously in the second stage of labor. Similarly, Valsalva pushing women were informed about the Valsalva pushing technique (closed glottis pushing while holding their breath) and were supported in using Valsalva pushing in the second stage of labor. Length of stages of delivery, perineal tears, postpartum hemorrhage, maternal fatigue and satisfaction were evaluated in mothers; and levels and Apgar scores at 1 and 5 minutes were evaluated in newborns in both groups. Data were collected by means of questionnaires. The data were analyzed using SPSS software and descriptive statistical and Mann- whitney, x2 and independent T.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805252170N2
Registration date:2011-03-01, 1389/12/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-01, 1389/12/10
Registrant information
Name
Tahmineh Salehian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 7223 3735
Email address
salehian@zdmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effects of Spontaneous pushing versus Valsalva pushing technique in Birth on outcome of delivery in primiparous in Iran hospital in 2009.
Public title
Comparing effects of Spontaneous pushing versus Valsalva pushing technique in Birth on outcome of delivery in primiparous in Iran hospital in 2009.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria;including Iranian women; primiparous; singleton; cephalic ; gestational age 42-38 weeks; dilatation 4 cm; having a normal delivery conditions
Exclusion criteria: having a chronic disease; PROM; painless childbirth; high risk pregnancy; fast delivery; each leading to emergency caesarean; arrest labor
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics Committee, Zahedan University of Medical Sciences
Street address
Pardis society, Dr Hesabi square, University of Medical sciences, Zahedan
City
Iranshahr
Postal code
9914786138
Approval date
2009-05-16, 1388/02/26
Ethics committee reference number
1090
Health conditions studied
1
Description of health condition studied
effects of pushing technique in Birth on outcome of delivery
ICD-10 code
O63.1
ICD-10 code description
Prolonged second stage of labour
Primary outcomes
1
Description
postpartum hemorrhage
Timepoint
2 hourse postpartum
Method of measurement
pad Weight
Secondary outcomes
1
Description
maternal satisfaction
Timepoint
2 hour after delivery
Method of measurement
questionnaire
Intervention groups
1
Description
Spontaneous pushing women were informed about spontaneous pushing technique (open glottis pushing while breathing out) and were supported in pushing spontaneously in the second stage of labor.
Category
N/A
2
Description
Valsalva pushing women were informed about the Valsalva pushing technique (closed glottis pushing while holding their breath) and were supported in using Valsalva pushing in the second stage of labor.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran hospital in iranshahr
Full name of responsible person
Tahmineh Salehian
Street address
Dept of Nursing & Midwifery Iranshahr
City
Iranshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan university of Medical sciences
Full name of responsible person
Dr.Hamidreza Mahmodzade Sagheb
Street address
Pardis society, Dr Hesabi square, University of Medical sciences, Zahedan
City
Iranshahr
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, Zahedan 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
Zahedan university of Medical sciences
Full name of responsible person
Mrs Neda Mohamadinia
Position
Academic Member Dept of Nursing & Midwifery, University of Medical Sciences , Zahedan
Other areas of specialty/work
Street address
Midwifery Dep.Iranshahr Faculty of Medical sciences Iranshahr
City
Iranshahr
Postal code
9914786138
Phone
+98 54 7331 0482
Fax
Email
Tahminehsalehian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences , Zahedan
Full name of responsible person
Mrs Tahmineh Salehian
Position
master degree of Midwifery
Other areas of specialty/work
Street address
Dept of Nursing & Midwifery Iranshahr
City
Iranshahr
Postal code
9914786138
Phone
+98 54 7331 0482
Fax
Email
Tahminehsalehian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mrs Neda Mohamadinia
Position
Faculty of Nursing and Midwifery, Iranshahr
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Iranshahr
City
Iranshahr
Postal code
9914786138
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)