The effect of banana and date consumption by pregnant mother on non-reactive fetal heart rate reactivity
Design
In this phase 3 clinical trial, with a control group, by using random number table 160 participants in this study into 4 groups including: group A (consumption of one banana and 500 cc of water), group B (consumption of 7 dates and 500 cc of water), group C (consumption of 500 cc of water and 25 grams of glucose) and the control group(D)(consumption of 500 cc of water) were divided. This study is not blinded.
Settings and conduct
In this clinical trial without blinding, 160 pregnant women with 37 weeks of pregnancy and more referring to the midwifery clinic of Hajar Hospital to perform fetal heart rate reactivity are randomly assigned to four groups. In order to evaluate the effect of dates, bananas, glucose are studied
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• singleton pregnancy.
• Pregnancy age 36-40 weeks.
• Non-reactive test without stress.
• The normality of the basic heart rate of the fetus (110-160)
Exclusion criteria:
• Multiple pregnancy
• Mother's history or suffering from diseases such as diabetes, blood pressure, heart, kidney and thyroid diseases
• Fetus with intrauterine growth restriction
• Rupture of water sac or reduction of amniotic fluid
Intervention groups
The intervention groups include: group A (consumption of one banana and 500 cc of water), group B (consumption of 7 dates and 500 cc of water), group C (consumption of 500 cc of water and 25 grams of glucose) and control group(D) (consumption of 500 cc of water) Water)
Main outcome variables
Non-Reactive Fetal heart rate reactivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160709028844N3
Registration date:2023-06-13, 1402/03/23
Registration timing:retrospective
Last update:2023-06-13, 1402/03/23
Update count:0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Sheida Shabanian
Name of organization / entity
Shaharekord University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 38 3228 4014
Email address
shabanian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-22, 1397/05/31
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
2018-10-22, 1397/07/30
Actual recruitment end date
2019-03-19, 1397/12/28
Trial completion date
2019-04-29, 1398/02/09
Scientific title
Comparison of the effect of banana and date consumption by pregnant mother on the reactivity of non-reactive fetus NST test
Public title
The effect of banana and date consumption on the reactivity of non-reactive fetus NST test
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy
Pregnancy age 36-40 weeks
Non-reactive test without stress
The normality of the basic heart rate of the fetus (110-160)
Fetal health according to ultrasound evidence
Mother fasting (three hours before the test)
Normal body mass index
Exclusion criteria:
Multiple pregnancy
Mother's history or suffering from diseases such as diabetes, blood pressure, heart, kidney and thyroid diseases
The use of painkillers, narcotics and sedatives and drugs affecting uterine contractions by the mother
Fetus with intrauterine growth restriction
Vaginal bleeding
Rupture of water sac or reduction of amniotic fluid
Beginning of uterine contractions
Allergy to bananas or dates
Unwillingness to cooperate
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple randomization method, the participants are assigned to 4 groups. For this purpose, 160 identical cards, on which 40 letters A, 40 letters B, 40 letters C, and 40 letters D are inserted, are mixed in an envelope and one card is randomly drawn for each participant. The letter inserted on the card will show the treatment group of the patient.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani street
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.SKUMS.REC.1397.302
Health conditions studied
1
Description of health condition studied
Non-reactive fetal heart rate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Non-Reactive Fetal heart rate
Timepoint
Before and after the intervention, the fetal heart rate test will be recorded. If there are 2 times of increasing the heart rate of the fetus by the number of 15 from the base line for 15 seconds, the result is Reactive
Method of measurement
before and after the intervention, the fetal heart rate test will be recorded and studied. The fetal heart rate test is recorded on both occasions by a computerized device, and if there are 2 times of increasing the heart rate of the fetus by the number of 15 from the base line for 15 seconds, the result is Reactive.
2
Description
Before and one hour after the intervention, the blood sugar of the participants will be measured and recorded.
Timepoint
Before and one hour after the intervention, the blood sugar of the participants will be measured and recorded with a glucometer.
Method of measurement
Glucometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: consumption of one banana and 500 cc of water
Category
Treatment - Other
2
Description
Intervention group B: Consumption of 7 dates and 500 cc of water
Category
Treatment - Other
3
Description
Intervention group C: Consumption of 500 cc of water and 25 grams of glucose
Category
Treatment - Other
4
Description
Control group(D): Consumption of 500 cc of water
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Midwifery Clinic of Hajar Hospital
Full name of responsible person
Sheida Shabanian
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3228 4014
Email
sheidashabanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Reisi
Street address
Shahrekord, Kashani Blvd, University Headquarters
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Research credits of Shahrekord University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Assistant Professor of Shahrekord University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 4, Yaser St. 36
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815754673
Phone
+98 38 3228 4014
Email
sheidashabanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Assistant Professor of Shahrekord University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 4, Yaser St. 36
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815754673
Phone
+98 38 3228 4014
Email
sheidashabanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida shabanian
Position
Assistant Professor of Shahrekord University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 4, Yaser St. 36
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815754673
Phone
+98 38 3228 4014
Email
sheidashabanian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.
From where data/document is obtainable
In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The
contact methods are the email address sheidashabanian@yahoo.com or the contact number 009891103122195.
What processes are involved for a request to access data/document
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.