Objectives: This clinical trial has been designed to evaluate the effect of educational course of the physiologic delivery on pregnant woman self-efficacy. Design: The study population will be pregnant woman who refer to selected Isfahan health centers. Mothers randomly will be divide into two groups, one group is control (without training) and another be intervention (with 8 sessions training). Sample size is thirty six women in each group. This study is a single blind clinical trial for participants in the intervention and control groups. Setting and conduct: With available sampling, gradually selected pregnant women eligible inclusion criteria and randomly placed in the intervention and control groups. Inclusion criteria: mothers with age 18-32 years; ability to read and write.
Exclusion criteria: multipara pregnancy with CS history; PROM; preterm delivery in the current pregnancy; gestational hypertension; cervical failure; IUGR; multiple pregnancy; placenta previa after 27 weeks of pregnancy; two and three trimester persistent bleeding.
Intervention: For intervention group, eight educational sessions (benefits of vaginal delivery, exercise for pregnancy and childbirth, relaxation exercise during labor and physiologic delivery) will be held during pregnancy. The control group will not receive any training. Main outcome measures: Before, one week and one month after intervention, pregnant woman self-efficacy will be evaluated by the questionnaire in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112223657N2
Registration date:2016-02-06, 1394/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Zeinab Heidari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 101 5058
Email address
zeinab_heidari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-08-24, 1394/06/02
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare the effect of the participate and not participate in courses of the physiologic delivery on pregnant woman self-efficacy
Public title
Survey the effect of educational course of the physiologic delivery on pregnant woman self-efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: mothers with age 18-32 years; ability to read and write.
Exclusion criteria: multipara pregnancy with CS history; PROM; preterm delivery in the current pregnancy; gestational hypertension; cervical failure; IUGR; multiple pregnancy; placenta previa after 27 weeks of pregnancy; two and three trimester persistent bleeding
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.MUI.REC.1394.4.092
Health conditions studied
1
Description of health condition studied
Self-efficacy
ICD-10 code
075.5
ICD-10 code description
Maternal distress during labour and delivery
Primary outcomes
1
Description
Pregnant woman self-efficacy
Timepoint
Before, one week and one month after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For intervention group, 8 educational sessions (benefits of vaginal delivery, exercise for pregnancy and childbirth, relaxation exercise during labor and physiologic delivery) will be held during pregnancy.
Category
Behavior
2
Description
The control group will not receive any training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Navab Health and Treatment Center
Full name of responsible person
Street address
Bozorgmehr St. Ahmad Abad Sq.
City
Isfahan
2
Recruitment center
Name of recruitment center
Eighteen Khajo Health and Treatment Center
Full name of responsible person
Street address
Sharif Vaghefi St.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahdi Neamatbakhsh
Street address
Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mojgan Khosravi
Position
Midwife
Other areas of specialty/work
Street address
Eighteen Khago Health and Treatment Center, Sharif Vaghefi St.
City
Isfahan
Postal code
Phone
+98 913 167 9738
Fax
Email
M.Khosravi334@yhoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shahnaz Kohan
Position
Phd of Reproductive Health
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Postal code
Phone
+98 31 3792 7537
Fax
Email
Kohan@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zeinab Heidari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)