In this before-after clinical trial, 100 pregnant women who are determined to give birth by cesarean section, attended to two health clinics affiliated to Sabzevar University of Medical Sciences will be included. In one health center during one session, benefits of vaginal delivery for mother and baby, risks of cesarean, and cases in which cesarean is lifesaving are discussed for pregnant women and their husbands. In another health center, routine education about cesarean and normal delivery are given to mothers.Investigated outcomes include husbands’ opinion about the mode of delivery and woman’s decision about mode of delivery after the intervention and one month later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605298548N2
Registration date:2016-06-28, 1395/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-28, 1395/04/08
Registrant information
Name
Foroughossadat Mortazavi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
frmortazavi@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Sabzevar University of Medical Sciences
Expected recruitment start date
2015-08-31, 1394/06/09
Expected recruitment end date
2016-08-31, 1395/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a preparing program about advantages of vaginal delivery for pregnant women and their husbands on their preferred mode of delivery
Public title
The effect of education about advantages of vaginal delivery on preferred mode of delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria; primiparity or having a history of vaginal delivery; consented to participate in the study; gestational age between13-26 weeks; requesting cesarean section as the preferred mode of delivery with no medical or obstetrical indication for; having the ability to read
Exclusion criterion: husband’s nonattendance in the clinic
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not 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 Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Approval date
2014-12-01, 1393/09/10
Ethics committee reference number
Medsab.Rec.93.37
Health conditions studied
1
Description of health condition studied
Elective caesarean
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
pregnant woman's preference of vaginal delivery
Timepoint
after the intervention and one month later
Method of measurement
one question in Likert scale
Secondary outcomes
1
Description
husband's preference of vaginal delivery
Timepoint
after intervention and one month later
Method of measurement
one question in a Likert scale
Intervention groups
1
Description
Women with husbands group: In a visit with 50 couples hold by a midwife, advantages of vaginal delivery for pregnant women, risks of cesarean, and cases in which cesarean are lifesaving and necessary are discussed. All discussed materials are given to couples in the format of pamphlets
Category
Prevention
2
Description
Women group: In a visit with 50 pregnant women hold by a midwife, advantages of vaginal delivery for pregnant women, risks of cesarean, and cases in which cesarean are lifesaving and necessary are discussed. All discussed materials are given to women in the format of pamphlets
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Aldaghi Health Center
Full name of responsible person
Forough Mortazavi
Street address
N 12, Sihezarmetri square
City
Sabzevar
2
Recruitment center
Name of recruitment center
Hemat Abad Health Center
Full name of responsible person
Forough Mortazavi
Street address
N24, Iesi avenue, Zand square
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Mohammadzadeh
Street address
Sabzevar University of Medical Sciences, Road Police station, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
393080242
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Sabzevar 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
Sabzevar, University of Medical ُSciences
Full name of responsible person
Foroughossadat Mortazavi
Position
faculty member
Other areas of specialty/work
Street address
Sabzevar University of Medical ُSciences, Police road station, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
frmortazavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Foroughossadat Mortazavi
Position
faculty member
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Police Road Station, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
frmortazavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Foroughossadat Mortazavi
Position
Faculty member
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Police Road Station, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
frmortazavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)