The aim of this clinical trial, is to detect the effect of fetal movement counting on general health, anxiety, depression and pregnancy outcomes .The inclusion criteria contains: singelton pregnancy, Not having been terminated pregnancy, no previous abortion and Refusing to participate in research on reduced fetal movement and the exclusion criteria contains: igohydroamnious and Maternal smoking and drugs .The population of study containing the primiparous women with singelton pregnancy . The method of sampling will be rondomely . the independent variable will be the fetal movement counting and the independent variables will be general health, anxiety, antenatal depression and pregnancy outcomes .
General information
Acronym
fetal movement counting
IRCT registration information
IRCT registration number:IRCT201207103078N9
Registration date:2012-12-06, 1391/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Masoumeh Delaram
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
mdelaram@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University Of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fetal movement counting on general health, anxiety, and depression of mother and outcome of pregnancy
Public title
The effect of fetal movement counting on general health, anxiety, and depression of mother and outcome of pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: singelton pregnancy; Not having been terminated pregnancy; no previous abortion; Refusing to participate in research on reduced fetal movement
Exlusion Criteria: Oligohydroamnious; Maternal smoking and drugs
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Shahrekord University Of Medical Sciences
Street address
Shahrekord University Of Medical Sciences, Kashani Avenue, Shahrekord, Iran
City
Shahrekord
Postal code
Approval date
2012-09-25, 1391/07/04
Ethics committee reference number
14-7-91
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
general health
Timepoint
from 28 weeks to 37 weeks
Method of measurement
questionnire
2
Description
anxiety
Timepoint
from 28 weeks and 37 weeks
Method of measurement
questionnire
3
Description
antenatal depression
Timepoint
from 28 weeks and 37 weeks
Method of measurement
questionnire
4
Description
pregnancy outcome
Timepoint
after birth
Method of measurement
check list
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
In intervention group, fetal movement counting will be done from 28 to 37 weeks of gestation.
Category
Prevention
2
Description
control group will not be recieve the intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers and Hajar Hospital in Shahrekord
Full name of responsible person
Masoumeh Delaram
Street address
Faculty of nursing and Midwifery, Shahrekord University Of Medical Sciences, Shahrekord, Iran
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University Of Medical Sciences, Shahrekord, Iran
Full name of responsible person
Dr. Mahmood Mobasheri
Street address
Faculty of nursing and Midwifery, Shahrekord University Of Medical Sciences, Shahrekord, Iran, Faculty Of Nursing and Midwifery
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University Of Medical Sciences, Shahrekord, Iran
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
Shahrekord University Of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc. in Midwifery
Other areas of specialty/work
Street address
Faculty of nursing and Midwifery, Shahrekord University Of Medical Sciences, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.commdelaram@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc. in Midwifery
Other areas of specialty/work
Street address
Faculty of nursing and Midwifery, Shahrekord University Of Medical Sciences, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.commdelaram@skums.ac.ir
Web page address
http://www.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc. in Midwifery
Other areas of specialty/work
Street address
Faculty of nursing and Midwifery, Shahrekord University Of Medical Sciences, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.commdelaram@skums.ac.ir
Web page address
http://www.skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)