Objectives: To assess the effect of educational program versus no cesarean rate in pregnant mothers.
Design: a clinical trial.
Setting and conduct: The eligible pregnant mothers who will refer to Fatemieh or Atieh Hospitals during the study period will be enrolled into the trial.
Inclusion criteria: Nulliparous pregnant women.
Exclusion criteria: (a) history of abortion; (b) contraindication of physical activity.
Intervention group 1: Routine pregnancy period education plus educational intervention program, 8 sessions, 60 hours each, from 20 weeks of gestational age, based on Ministry of Health protocol.
Intervention group 2: Routine pregnancy period education plus educational intervention program, 8 sessions, 60 hours each, from 20 weeks of gestational age, based on researcher's need assessment.
Control group: Only routine pregnancy period education.
Primary outcome: Assessing the cesarean section rate at the end of pregnancy period based on medical records.
Secondary outcome: Nothing.
Randomization: Pregnant mothers who will refer to Fatemieh Hospital will receive the intervention and those who refer to Atieh Hospital will be considered as control.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512169014N86
Registration date:2015-12-26, 1394/10/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-26, 1394/10/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational program versus no cesarean rate in pregnant mothers: a clinical trial
Public title
Effect of educational program versus no cesarean rate in pregnant mothers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous pregnant women.
Exclusion criteria: history of abortion; contraindication of physical activity.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Primary outcome: Assessing the cesarean section rate at the end of pregnancy period based on medical records.
Secondary outcome: Nothing.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.UMSHA.REC.1394.399
Health conditions studied
1
Description of health condition studied
Caesarean section
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Assessing the cesarean section rate
Timepoint
at the end of pregnancy period
Method of measurement
based on medical records
Secondary outcomes
empty
Intervention groups
1
Description
Routine pregnancy period education plus educational intervention program, 8 sessions, 60 hours each, from 20 weeks of gestational age, based on Ministry of Health protocol
Category
Other
2
Description
Routine pregnancy period education plus educational intervention program, 8 sessions, 60 hours each, from 20 weeks of gestational age, based on researcher's need assessment
Category
Other
3
Description
Only routine pregnancy period education
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Marzieh Otoogara
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Marzieh Otoogara
Position
PhD Student in Health Education
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
m_otogara@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Dr Akram Karimi Shahanjarini
Position
Assistant Professor of Health Education
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
karimi.a@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)