The effect of education courses to pregnant women and their husbands with previous adverse outcomes on the quality of life and maternal – fetal attachment of pregnant women with previous adverse outcomes, RCT.
Title of proposal: The effect of education courses on pregnant women and their husbands with previous adverse outcomes on the quality of life and maternal – fetal attachment of pregnant women with previous adverse outcomes, RCT.
Randomized controlled clinical trials
Inclusion Criteria in pregnant women:
1.Pregnant women at 24-28 weeks
2.Pregnant women at sarab health centers have mirage health records
3.Hahving at least a third literacy
4.Previous history of adverse consequences in pregnancy such as preterm delivery, low birth weight, stillbirth, miscarriage, neonatal death
5.Consent to participate in the project
6.Having a singleton pregnant women
7.Age 35- 18 years
8.The Edinburgh depression score less than 12
9.To participate in other similar studies
Inclusion Criteria in fathers:
1.Hahving at least a third literacy
2.Consent to participate in the project
3.The Edinburgh depression score less than 12
4.Having healthy physical, mental, according to the individual
Exclusion Criteria in pregnant women:
1.Mothers with unwanted pregnancies
2.Mothers who want to shift to another place during pregnancy
3.Having a close death, divorce and other serious emotional problems in the past month
4. history of gestational diabetes, preeclampsia, high blood pressure or any other condition that affect maternal health
5.Known to have psychological problems, according to his mother
6.Having fetal malformations and other fetal complications in the current pregnancy
7.Pregnant women who attended prenatal classes
intervention: Holding four education courses for mothers on the quality of life and two education courses for mothers and their husbands on the maternal -fetal attachment
time of intervention:
Pregnant women at 24-28 weeks
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601043027N30
Registration date:2016-04-04, 1395/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-04, 1395/01/16
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, tabriz University of Medical Sciences
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-05-26, 1395/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education courses to pregnant women and their husbands with previous adverse outcomes on the quality of life and maternal – fetal attachment of pregnant women with previous adverse outcomes, RCT.
Public title
The effect of education courses to pregnant women and their husbands on the quality of life and maternal – fetal
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria in pregnant women:
.Pregnant women at 24-28 weeks
2.Pregnant women at sarab health centers have mirage health records
3.Hahving at least a third literacy
4.Previous history of adverse consequences in pregnancy such as preterm delivery, low birth weight, stillbirth, miscarriage, neonatal death
5.Consent to participate in the project
6.Having a singleton pregnant women
7.Age 35- 18 years
8.The Edinburgh depression score less than 12
9.To participate in other similar studies
Inclusion Criteria in fathers:
1.Hahving at least a third literacy
2.Consent to participate in the project
3.The Edinburgh depression score less than 12
4.Having healthy physical, mental, according to the individual
Exclusion Criteria in pregnant women:
1.Mothers with unwanted pregnancies
2.Mothers who want to shift to another place during pregnancy
3.Having a close death, divorce and other serious emotional problems in the past month
4. history of gestational diabetes, preeclampsia, high blood pressure or any other condition that affect maternal health
5.Known to have psychological problems, according to his mother
6.Having fetal malformations and other fetal complications in the current pregnancy
7.Pregnant women who attended prenatal classes
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz University of Medical Sciences
Street address
azadi AVE, golgasht Ave,Central Building University of Medical Sciences, tabriz, iran.
City
tabriz
Postal code
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
tbzmed.rec.1394.969
Health conditions studied
1
Description of health condition studied
quality of life and maternal- fetal attachment in pregnant women
ICD-10 code
094-099
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
quality of life of pregnant women and maternal - fetal attachment
Timepoint
previous of intervention and one month after intervention
Method of measurement
sf-36 for quality of life and Cranley MFA Scale
Secondary outcomes
1
Description
anxiety
Timepoint
previous of intervention and one month after intervention
Intervention group : : Holding four education courses for mothers on the quality of life and two education courses for mothers and their husbands separatly on the maternal -fetal attachment for 60-90 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarab city health center
Full name of responsible person
bita asgharian
Street address
motahhari avenue- sarab
City
sarab
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of tabriz University of Medical Sciences
Full name of responsible person
dr mirghafourvand
Street address
shariaty ave, tabriz,iran
City
tabriz
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 of tabriz 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
faculty of nursing and midwifery
Full name of responsible person
fahimeh sehhatie shafaie
Position
Assistant Professor
Other areas of specialty/work
Street address
shariaty Ave, tabriz, iran
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
sehhatief@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
faculty of nursing and midwifery
Full name of responsible person
fahimeh sehatie shafaie
Position
Assistant Professor
Other areas of specialty/work
Street address
shariaty Ave, tabriz.iran,
City
tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
sehhatief@ tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
faculty of nursing and midwifery
Full name of responsible person
fahimeh sehhatie shafaie
Position
Assistant Professor
Other areas of specialty/work
Street address
faculty of nursing and midwifery sharaiaty Ave, tabriz, iran.
City
tabriz
Postal code
5138947977
Phone
+98 4104134796770
Fax
+98 41 3475 2839
Email
sehhatief@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)