Comparison of the effect of caffeine consumption and voice stimulation before biophysical profiling on the biophysical profile of fetal profile in pregnant women with single pregnancy
The effect of taking caffeine by the mother before performing biophysical profiles on embryonic biophysical profile
Design
Clinical trial with control and intervention group, with parallel groups, Not blind, randomized ,Sample size 150 people
Settings and conduct
This study will be conducted on 150 patients referring to Tabriz Al-Zahra Health Center. They will be randomly divided into 3 groups of 50 people.
Control group: group (control) received no intervention.
The intervention group A: 20 grams of instant coffee powder, made in France, containing 120 mg of caffeine, dissolved in 200 cc of boiling water and drank before the procedure.
Intervention group Two: The acoustic stimulus recipient will be hit by the metal rod next to the patient's bed, before the procedure, using a reflex hammer.
Participants/Inclusion and exclusion criteria
Pregnant mothers are candidates for a biophysical test for embryonic profiles that are willing to participate in the study and will not be included in the study if they have a mental illness or bleeding and pain.
Intervention groups
Control group: group (control) received no intervention.
The intervention group A: 20 grams of instant coffee powder, made in France, containing 120 mg of caffeine, dissolved in 200 cc of boiling water and drank before the procedure.
Intervention group Two: The acoustic stimulus recipient will be hit by the metal rod next to the patient's bed, before the procedure, using a reflex hammer.
Main outcome variables
Amount of time needed to complete the biophysical profile and Biophysical Profiles Scours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190304042912N2
Registration date:2019-07-28, 1398/05/06
Registration timing:registered_while_recruiting
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
sanaz moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
musevis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-24, 1398/05/02
Expected recruitment end date
2020-07-23, 1399/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of caffeine consumption and voice stimulation before biophysical profiling on the biophysical profile of fetal profile in pregnant women with single pregnancy
Public title
The effect of taking caffeine by the mother before performing biophysical profile on fetal biophysical profile
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
En Pregnant mothers are candidates for a biophysical test for embryonic profiles
Having the consent to participate in the study
Exclusion criteria:
have a mental illness
bleeding
pain
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were divided randomly into three groups of 50: group I (control) received no intervention; group II (caffeine-recipient) took caffeine before the procedure; and group III (acoustic stimulation) received acoustic stimulation before the procedure using a reflex hammer.
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
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.TBZMED.REC.1398.031
Health conditions studied
1
Description of health condition studied
Evaluating the health of the fetus
ICD-10 code
P00
ICD-10 code description
Fetus and newborn affected by maternal conditions that may be unrelated to present pregnancy
Primary outcomes
1
Description
Amount of time needed to complete the biophysical profile
Timepoint
the time elapsed to begining of fetal heart rate reactivity
The intervention group A: 20 grams of instant coffee powder, made in France, containing 120 mg of caffeine, dissolved in 200 cc of boiling water and drank before the procedure.
Category
Diagnosis
3
Description
Intervention group Two: The acoustic stimulus recipient will be hit by the metal rod next to the patient's bed, before the procedure, using a reflex hammer.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sanaz Musavi
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Juiban
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Musavi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Musavi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Musavi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available