A Randomized controlled trial of comparison effect of acoustic stimulation test and nutrition on nonstress test (NST) results in pregnant women with nonreactive NST.
The objective of this study is to compare the effect of acoustic stimulation test and maternal nutrition on nonreactive nonstress test (NST) in pregnant women. This randomized clinical trial has been carried out at Alzahra hospital of Tabriz. A total of 104 (52 in each group) pregnant women, who are at 32 - 42 weeks of gestation with singleton pregnancy who intended to participate in the study and also who have nonreactive NST, are randomly allocated in two groups. Randomization is done with Power and Sample Size software. In the first group, we give them one cake and fruit juice, and in another group we induce acoustic stimulation, which is caused by clapping hands about 1 cm above maternal abdomen over the fetal vertex.
After 30 minutes NST is done in the same context in two groups. Then data will be analyzed with SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201148459N2
Registration date:2012-08-28, 1391/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-28, 1391/06/07
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-06-10, 1391/03/21
Expected recruitment end date
2012-09-10, 1391/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized controlled trial of comparison effect of acoustic stimulation test and nutrition on nonstress test (NST) results in pregnant women with nonreactive NST.
Public title
Comparison of acoustic stimulation test and maternal nutrition on nonreactive nonstress test in pregnant women referring to Alzahra Hospital, 2012.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1- Intention to participate
2- Singleton pregnancy
3- Pregnancy age between 32-42 weeks
4- Nonreactive results of Non Stress Test
5- Without any pelvic diseases
6- Fetal heart rate between 120-160 beat per minute
7- No harmful habits such as cigarette and alcohol
Exclusion criteria:
1- Rupture of membrane
2- Labor pain
3- Fetal distress
4- Using opioids and tocolytics.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
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 Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Postal code
Approval date
2011-11-11, 1390/08/20
Ethics committee reference number
6631/4/5
Health conditions studied
1
Description of health condition studied
fetal nonreactive NST
ICD-10 code
P20.0
ICD-10 code description
Intrauterine hypoxia first noted before onset of labor
Primary outcomes
1
Description
Non stress test
Timepoint
30 minutes after intervention
Method of measurement
Electronic monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Giving one cake and fruit juice in first intervention group
Category
Diagnosis
2
Description
Acoustic stimulation (3-5 time clapping hands about 1 cm above maternal abdomen near the fetal vertex) in second intervention group
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Shirin Hasanpoor
Street address
Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht Street
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, 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
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpoor
Position
Instructor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Shariaty Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpoor
Position
Master of Science in midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Shariaty Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Instructor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Shariaty Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
shirinhasanpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)