The main objective of this study is to evaluate the effect of a computerized decision aid (CDA) system on empowering pregnant women in choosing an appropriate mode of delivery. This CDA contrasts the advantages and disadvantages of vaginal versus cesarean section delivery in terms of their value to the individual woman. The CDA provides educational contents as well as some recommendations. The CDA’s software will be installed on women’s computer to be used at home. The protocol concerns a randomized trial study that will be performed among Iranian women. Four hundred pregnant women will be recruited from two private and two public prenatal centers in Mashhad, Iran. They will be randomly assigned in either an intervention or control group. The designed CDA will be provided to the intervention group whereas the control group will only receive routine care. Because the study is not blinded we use blocked randomization to ensure equal group sizes within each. Pregnant women 16 years and older who had 28 or more weeks of gestation are eligible to be enrolled in the study. Women are excluded if they unable to read and write or unable to work with a computer .The two primary outcomes for the study are O’Connor’s decisional conflict scale and knowledge as measured by true/false questions. The duration of the intervention is considered from recruitment to the time of delivery. After intervention evaluation will be taken at 38 weeks of gestation.
General information
Acronym
CDAs
IRCT registration information
IRCT registration number:IRCT2015093010777N4
Registration date:2015-10-26, 1394/08/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-26, 1394/08/04
Registrant information
Name
Azam Aslani Mamghani
Name of organization / entity
Mashhad University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 1894 2657
Email address
aslania881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-04-10, 1395/01/22
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of a computerized decision aid on empowering pregnant women for choosing vaginal versus cesarean section delivery
Public title
computerized patient decision aid system
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women 16 years and older; gestational age 28 week or more; singleton pregnancy.
Exclusion criteria: Women do not provide a written informed consent; unable to read and write; unable to work with a computer; women whose method of delivery is predetermined by the physician, based on their clinical condition
Age
From 16 years old to 48 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
400
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 Biomedical research, Mashhad University of Medical Sciences- IR.MUMS.REC
Street address
Ghoreishi building Daneshgah street
City
Mashhad
Postal code
۳۴۵ - ۹۱۳۷۵
Approval date
2015-09-15, 1394/06/24
Ethics committee reference number
IR.MUMS.REC.1391.801
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80.9
ICD-10 code description
Single spontaneous delivery, unspecified
Primary outcomes
1
Description
Decisional Conflict
Timepoint
Before the intervention and 4 till 10 weeks after of the intervention
Method of measurement
O’Connor's decisional conflict scale - University of Ottawa
2
Description
knowledge
Timepoint
Before the intervention and 4 till 10 weeks after of the intervention
Method of measurement
true/false questions
Secondary outcomes
1
Description
Decisional Conflict subscales
Timepoint
Before and after of the intervention
Method of measurement
O’Connor's decisional conflict scale - University of Ottawa
Intervention groups
1
Description
Intervention group will receive a computer based decision aids on mode of delivery in addition to conventional care .
Category
Other
2
Description
Control group will receive the conventional care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Public health centers
Full name of responsible person
Fatemeh Tara
Street address
16 Ayatollah Behjat street Zarine Intersection
City
Mashhad
2
Recruitment center
Name of recruitment center
private offices
Full name of responsible person
Azam Aslani
Street address
Department of Medical Informatics School of medicine, Pardis university campus, Park square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice chancellor for research
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
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Position
Vicar of research
Other areas of specialty/work
Street address
Ghoreishi building, Daneshgah street
City
Mashhad
Postal code
91775-1365
Phone
+98 51 3882 3251
Fax
Email
tafaghodim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Saeid Eslami
Position
Pharm.D.; Ph.D
Other areas of specialty/work
Street address
Department of Medical Informatics, school of medicine, Pardis university campus, Park square
City
Mashhad
Postal code
Phone
+98 51 3800 2429
Fax
Email
eslams@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Azam Aslani
Position
PhD of medical informatics
Other areas of specialty/work
Street address
Department of Medical Informatics, school of medicine, Pardis university campus, Park square
City
Mashhad
Postal code
Phone
+98 21814524214
Fax
Email
azamaslani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)