Protocol summary

Summary
This is a randomized, clinical trial study by aim of comparison the effects of group and individual health counseling on knowledge, attitude and choice of delivery mode in nulliparous women in Dezful city. The nulliparous women in 20 to 26 weeks of pregnancy, who come to the health centers for performing their prenatal care, will be included in the study after receiving verbal and written consent. The women with a normal situation for vaginal delivery will be interviewed to determine their delivery method’s tendency and if they select the cesarean delivery method, they by using closed envelopes and randomly assigned into two groups: group counseling (50 women) and individual counseling (50 women). At the beginning and after the counseling sessions, each group should fill up a pre-test and post-test questionnaire to assess their knowledge, attitude and delivery method’s choice. The researcher will manage the counseling sessions. Finally, their delivery function will be assessed in the hospital or by evaluating their documents.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015061422720N1
Registration date: 2015-09-01, 1394/06/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-01, 1394/06/10
Registrant information
Name
Mahnaz Nosratabadi
Name of organization / entity
Ahvaz Jundishapur University Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3477
Email address
nosratabadi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of group and individual health counseling on knowledge, attitude and choice of delivery mode in first pregnant women
Public title
the effects of health counseling on knowledge, attitude and choice of delivery mode
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Iranian; At least primary school education; First pregnancy; Singleton pregnancy; gestational age between 20 to 26 weeks (based on the first day of the last normal menstruation); The applicant cesarean Exclusion criteria from the study : Highrisk pregnancy (preeclampsia , diabetes, uncontrolled gestational diabetes , a history of preterm delivery , intrauterine fetal death , etc); The history of infertility; Prohibition of vaginal delivery for any reason; without his consent or his wife to continue to participate in counseling sessions
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method: The names of eligible women by using closed envelopes placed in the bag, and are out of the bag equally and randomly, and are divided into two groups of separate and equally.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz JundiShapur University of Medical Sciences
Street address
University city, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
ir.ajums.rec.1394.92

Health conditions studied

1

Description of health condition studied
Awareness of the type of delivery
ICD-10 code
-
ICD-10 code description
-

2

Description of health condition studied
Attitude toward the type of delivery
ICD-10 code
-
ICD-10 code description
-

3

Description of health condition studied
Select the type of delivery
ICD-10 code
O83.9
ICD-10 code description
Assisted single delivery, unspecified

Primary outcomes

1

Description
knowledge of delivery mode
Timepoint
Before and one week after intervention the variable is measured .
Method of measurement
Questionnaires to measure knowledge

2

Description
Attitude toward the type of delivery
Timepoint
Before and one week after intervention the variable is measured .
Method of measurement
Questionnaire measuring attitudes

3

Description
Select of delivery mode
Timepoint
Before and one week after intervention the variable is measured
Method of measurement
Questionnaires to measurement the of delivery mode

Secondary outcomes

1

Description
Natural or cesarean delivery
Timepoint
After intervention and childbirth
Method of measurement
Evaluation of individual medical records or a hospital birth

Intervention groups

1

Description
One group (group counseling) received choosing birth method counseling.For each group 8 sessions are regulated with 10 to 12 participating in each group . Each session takes 90 to 120 minutes. Each group will received consultation once a week. Consultations is based on health counseling.
Category
Prevention

2

Description
One group (individual counseling) received choosing birth method counseling. for every participant 8 sessions are regulated. Each session takes 45 to 60 minutes. Each person will received consultation once a week. Consultations is based on health counseling.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in the city of Dezful
Full name of responsible person
Nosratabadi Mahnaz
Street address
Square Roghayeh, Street Roosta, Dezful
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaze
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, Ahvaz Jundishapur 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 Jundishapur University of Medical Sciences
Full name of responsible person
Nosratabadi Mahnaz
Position
MSc Midwifery Consultation
Other areas of specialty/work
Street address
University city, Ahvaze
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
mahnaz.nosratabadi@gmail.ac.com; nosratabadi.m@ajums.ac.ir
Web page address
www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hekmat Khadija
Position
Master of Midwifery
Other areas of specialty/work
Street address
University city, Ahvaze
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
hekmat46@gmail.com
Web page address
www.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nosratabadi Mahnaz
Position
MSc Midwifery Consultation
Other areas of specialty/work
Street address
University city, Ahvaze
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
nosratabadi.m@ajums.ac.ir
Web page address
www.ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...