Protocol summary

Summary
The present study is an integrative multilateral program that aims to maternal and neonatal health promotion. Objectives: 1- To determine perceived threat of unnecessary cesarean morbidity in pregnant women 2- To determine perceived self efficacy of unnecessary cesarean morbidity in pregnant women 3-To determine women ‘intention to delivery mode in pregnant women 4-To determine women ‘knowledge about delivery mode in pregnant women 5- To increase women's intention at least 80% to vaginal birth at the end of the educational sessions 6-To increase cesarean rate of participants in Shahroud in comparison of participants in other cities of Semnan Province Our approach concludes two stages:1- Designing the model 2- Administrating and evaluation of model Designing the model comprise the main factors effect on decision and performing cesarean surgery. Our interventions conclude: 1- Goal oriented trainings of birth skills to obstetricians and midwives in Shahroud to instruct the pregnant mothers 2- Structured instructions to pregnant women in prenatal classes during 8 sessions 3- Revision of fee for services for obstetricians, anesthesiologists and midwives 4- Amending the labor/delivery ward in order to decrease the fear and anxiety of labored women Sample size is 220 pregnant women in experiment and control groups Interventions: Instructions of necessary educations about physiologic delivery on the basis of "Extended Parallel Process Model" or EPPM during 8 sessions as prenatal educations and learning pain and fear control skills for childbirth for women in experiment group, whereas women in control do not get such educations but regular prenatal care. Inventory is a structured questionnaire through EPPM that will be given participants in experiment group before and after educations and subjects in control group near the expected date of delivery. Main constructs of EPPM and "knowledge and intention" will be compared in two groups. Final outcome is the mode of delivery that will be compared in two groups and the effectiveness of educations will be evaluated. Inclusion criteria include: no history of former cesarean of uterine surgery , general wellbeing with no indication for medical/surgical intervention , Persian literacy , singleton pregnancy and cephalic presentation , No scientific approved indication for cesarean surgery , Being at 18 gestational weeks and singleton pregnancy and cephalic presentation Exclusion criteria: Every induced systemic disease during present pregnancy which needs to medical or surgical intervention and every obstetrical/non obstetrical indication for cesarean section Finally, cesarean rates will be compared in Shahroud and other adjacent cities in Semnan Province during study time

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106215525N2
Registration date: 2011-06-27, 1390/04/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-06-27, 1390/04/06
Registrant information
Name
Sepidh Hajian
Name of organization / entity
Sharoud Mdical Science University
Country
Iran (Islamic Republic of)
Phone
+98 27 3339 5054
Email address
hajia@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and education , Shahroud University of Medical Sciences with collaboration of Health Deputy, Treatment Deputy and Logistic Deputy.
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing of educational,financial and revisional interventions of human factors and structural agents on cesarean rate reduction ,administration and evaluation of them in Shahroud and comparison with cesarean rate in adjucent cities
Public title
Cesarean rate reduction model
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include: No history of former cesarean of uterine surgery, general wellbeing with no indication for medical/surgical intervention , Persian literacy 4- singleton pregnancy and cephalic presentation , No scientific approved indication for cesarean surgery , Being at 18 gestational weeks , singleton pregnancy and cephalic presentation Exclusion criteria conclude: Every induced systemic disease during present pregnancy which needs to medical or surgical intervention, and every obstetrical/non obstetrical indication for cesarean section
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 220
Randomization (investigator's opinion)
N/A
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, 7th Tir Sq, Sharoud, Iran
City
Shahroud
Postal code
Approval date
2011-02-16, 1389/11/27
Ethics committee reference number
890/07

Health conditions studied

1

Description of health condition studied
Factors influencing health status and contact with health services
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy

Primary outcomes

1

Description
cesarean delivery
Timepoint
at the end of study
Method of measurement
calculating

Secondary outcomes

1

Description
self efficacy
Timepoint
before and after prenatal educations
Method of measurement
questionnaire

2

Description
knowledge
Timepoint
before and after prenatal educations
Method of measurement
questionnaire

3

Description
intention
Timepoint
before and after prenatal educations
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention in experiment group: 1- Prenatal educations mainly based on "Extended Parallel Process Model" are an essential intervention that will be given to 220 participants through 8 sessions. This Model discuss about fear incentive of health threatening factor that in the present study includes fear from potential threats of unnecessary cesarean section. These educations will be presented by trained midwives in maternal health centers in Shahroud .Women in control group will be given prenatal routine care. 2- Instructions to obstetricians and midwives on the basis of confirmed context provided by The Ministry of Health and Medical Education 3- Revision of labor/delivery wards space in Shahroud hospitals in order to applying coping skills (relaxation, breathing and maternal position amending) to reduce pain and anxiety during labor/delivery. 4- Increasing the fee for services of obstetricians, anesthesiologists and midwives in cases of vaginal delivery to avoiding unnecessary cesarean which may perform due to financial motivations.
Category
Prevention

2

Description
Participants in control group will not be educated likewise the intervention group on the basis of foregoing Model and will be given routine care
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Head of Delivery Ward , Dr.Said-e- Roghayeh Mirmajidi
Street address
Delivery Ward, Imam Hossein Hospital, Shahroud
City
Shahroud

2

Recruitment center
Name of recruitment center
Fatemiyeh Hospital
Full name of responsible person
Chaiman of Obstetrics & Gynecology Department, Dr.Mohammad Esmaeel Ajami
Street address
Delivery Ward, Fatemiyeh Hospital, 22Bahman Avenue, Shahroud
City
Shahroud

3

Recruitment center
Name of recruitment center
Azima health center
Full name of responsible person
Ms Fatemeh Khoda Bakhshi
Street address
Midwifery unit, Azima health center, Ferdosi Avenue, Shahroud
City
Shahroud

4

Recruitment center
Name of recruitment center
Shahid Sadri health center
Full name of responsible person
Ms Fahimeh Zolfaghari
Street address
Midwifery Unit, Shahid Sadri health center, Bagh Zendan Crossroad, Shahroud
City
Shahroud

5

Recruitment center
Name of recruitment center
Shahid Boujar health center
Full name of responsible person
Ms Zahra Ajoudani
Street address
Midwifery Unit, Shahid Boujar health center, Ayatollah Madani Blvd., Sahroud
City
Shahroud

6

Recruitment center
Name of recruitment center
Shohada-e- Mehdi abad health center
Full name of responsible person
Ms Fatemrh Zahra Ghasemi
Street address
Midwifery Unit, Shohada-e- Mehdi abad health center, 12St., Mehdi abad district, Shahroud
City
Shahroud

7

Recruitment center
Name of recruitment center
Bahar local health center
Full name of responsible person
Ms Karimi
Street address
Midwifery unit, Bahar local health center, Baharestan District, Shahroud
City
Shahroud

8

Recruitment center
Name of recruitment center
Shahrak Emam health center
Full name of responsible person
Ms Esmat Tahanian
Street address
Midwifery unit, Shahrak Emam health center, Shahrak -e- Emam, Ayatollah Kashani Blvd., Shahroud
City
Shahroud

9

Recruitment center
Name of recruitment center
Shahid Mohammadi Health Center
Full name of responsible person
Ms Nooshin Ahmadian
Street address
Midwifery unit, Shahid Mohammadi Health Center, Pishva St., Emam Avenue, Shahroud
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Dr.Sayed Abbas Mousavi
Street address
Vice chancellor for research, Shahroud University of Medical Sciences, 7th Tir Sq., Shahroud
City
Sahroud
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, Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Sepideh Hajian
Position
PhD student
Other areas of specialty/work
Street address
Reproductive Health Department, Shahroud University of Medical Sciences,7th Tir Sq., Shahroud, Iran
City
Shahroud
Postal code
Phone
+98 912 383 7649
Fax
Email
hajian74@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Sepideh Hajian
Position
PhD student
Other areas of specialty/work
Street address
Reproductive Health Department, Shahroud University of Medical Sciences, 7th Tir Sq., Shahroud, Iran
City
Shahroud
Postal code
Phone
+98 27 3339 5054
Fax
Email
hajian74@yahoo.cm ; hajia@shmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Sepideh Hajian
Position
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, 7th Tir, Shahroud
City
Shahroud
Postal code
Phone
Fax
Email
hajian74@yahoo.com
Web page address

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
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