This study was conducted to determine the effect of Doula on the severity of labor pains on primiparous women who were selected using simple random sampling and randomly divided into two groups of with doula and control group .Inclusion criteria were 18-34 years old, dilatation of cervix 4 cm and gestationl age between 38-42 week . exclusion criteria were psychological disorder, diabetes, hypertension. In this clinical trial study were selected 150 primiparous women who were hospitalized in labor centers and hospitals of zahedan.The severity of pain was measured at the beginning of active phase in the 4 cm and ended of active phase in the 10 cm cervical dilatation by means of Visual Analogue Scale. Duration of active phase and second stage and type of delivery were investigated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111156242N2
Registration date:2012-03-13, 1390/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-13, 1390/12/23
Registrant information
Name
Ameneh safarzadeh
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1241 8961
Email address
safarzadeh.a@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences.
Expected recruitment start date
2007-07-03, 1386/04/12
Expected recruitment end date
2009-02-15, 1387/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of doula supporting on the severity of pain and duration of active phase of labor in primiparous women
Public title
The effects Doula supporting on severity of labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: average 18-34 years; gestational age of 38-42 weeks; cephalic presentation; in active phase (4 cm of cervical dilatation) ;
Exclusion Criteria: up or down age with 18-34; Gestational age of up to 42 week or down of 38 week; twin pregnancy, breech presentation, latent phase
Age
From 18 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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 Zahedan University of Medical Sciences
Street address
Pardis Complex; Hesabi Squre; zahedan
City
Zahedan
Postal code
Approval date
2012-01-15, 1390/10/25
Ethics committee reference number
856
Health conditions studied
1
Description of health condition studied
labor
ICD-10 code
080.9
ICD-10 code description
spontaneous delivery,Single unspecified
Primary outcomes
1
Description
Pain Intensity
Timepoint
Initiation of active phase and end of active phase
Method of measurement
Visual Analogue Scale
2
Description
lenght of active phase
Timepoint
durind of first stage of labor
Method of measurement
chart of time by reasercher
Secondary outcomes
1
Description
Duration of second stage of labor
Timepoint
second stage of labor
Method of measurement
chart of time by researcher
Intervention groups
1
Description
Effect of doula in labor pain of doula group
Category
Treatment - Other
2
Description
Standard Care in control group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity Care of Mirjaveh
Full name of responsible person
Ameneh Safarzadeh
Street address
City
Mirjaveh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Taheri
Street address
Pardis Complex, Hesabi Square, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Ameneh Safarzadeh
Position
Master Degre ; Faculty Midwifery
Other areas of specialty/work
Street address
Pardis Complex; Hesabi Square; Zahedan
City
Zahedan
Postal code
Phone
+98 54 1244 6305
Fax
Email
safarzadeh40@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ameneh Safarzadeh
Position
Master Degree
Other areas of specialty/work
Street address
Nursing and Midwifery; Mashahir Square; Zahedan
City
Zahedan
Postal code
Phone
+98 54 1244 6305
Fax
Email
safarzadeh40@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
Ameneh Safarzadeh
Position
Master Degree; Faculty Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery; Mashahir Square; Zahedan
City
Zahedan
Postal code
Phone
+98 54 1241 9407
Fax
Email
safarzadeh40@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)