Effects of using grape, saffron, and Omani lemon syrup on breastfeeding pattern of mothers gave birth in hospitals Affiliated to Shiraz University of Medical Sciences in 2020.
Assessing the effect of using grape, saffron, and Omani lemon syrup on breastfeeding pattern of mothers gave birth.
Design
Clinical trials with control group and with parallel groups, triple blind randomized, phase 2-3 on 100 people will be done using excel software for randomization.
Settings and conduct
Sampling will be done in hospitals of Shiraz University of Medical Sciences.The study is triple blind.
Participants/Inclusion and exclusion criteria
1-Mothers aged 18-40 who are capable of participating in the study with their own satisfaction. 2- Mother and infant have no underlying diseases which prohibit breastfeeding. 3- Mother should be primigravida and have basic literacy. 4-The infant should be full-term and singleton. 5- Infant should be between 2500-4000 gr. 6- The newborn should be anatomically sound and be capable of sucking mother’s breast normally. 7- Mother should not have abnormal bleeding after labor. 8- Mother should pass a low-risk pregnancy. 9- Mother’s BMI should be ≤30 (not be obese). 10- Delivery should not be difficult using vacuum or forceps. 11- During the study, mother should not take breast milk enhancing medicine (herbal or chemical);
Exclusion criteria: 1- Mother’s severe postpartum bleeding.2-Possible sensitivity to syrup.3-not willing participants to continue the study.
Intervention groups
Intervention group: Active drug (grape, saffron, and Omani lemon syrup), control group: Placebo
Main outcome variables
Quantity and quality of breastfeeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200815048407N1
Registration date:2020-12-07, 1399/09/17
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Mahboobe Mojtahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4223 6150
Email address
mojtahedi.mahboobe@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of using grape, saffron, and Omani lemon syrup on breastfeeding pattern of mothers gave birth in hospitals Affiliated to Shiraz University of Medical Sciences in 2020.
Public title
Effects of using grape, saffron, and Omani lemon syrup on breastfeeding pattern of mothers gave birth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers are between 18-40 years old.
Mother and infant have no underlying diseases which prohibit breastfeeding.
The infant should be full-term and singleton.
Infant should be between 2500-4000 gr.
The newborn should be anatomically sound and be capable of sucking mother’s breast normally.
Mother should not have abnormal bleeding after labor.
Mother should pass a low-risk pregnancy.
Mother’s BMI should be ≤30 (not be obese).
Delivery should not be difficult using vacuum or forceps.
Mother should be primigravida and have basic literacy.
Mother should not take breast milk enhancing medicine (herbal or chemical).
Exclusion criteria:
Women with heavy postpartum bleeding.
Possible sensitivity to syrup
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize and allocate individuals to groups, random number function will be used. Randomization is as follow using excel software: first, groups will be entered in one column as A,B together; as the number of samples in each group has been defined as 50 (including sample drop), thus, B, A, should be entered in order and beneath. In the other column , using the command RAND , the random numbers are generated . In the next step, using the command sort, the generated random numbers will be organized ranging from lowest numbers to highest ones or vice versa, this will result a change in groups order as A, B. using the new order, individuals will be allocated to different groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is triple blind. This means that the researcher, participants, and statistic consultant will have no information about the drugs used by each group or each A or B syrup filled with which type of drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Niyayesh Intersection, Valiasre Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.076
Health conditions studied
1
Description of health condition studied
Pattern of mothers breastfeeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pattern of breastfeeding
Timepoint
1,3,10,30,90 days after delivery
Method of measurement
Breastfeeding pattern questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: syrup contains grape juice,saffron and dried lime / each12 hours 10cc for 6 weeks / the syrups will be provided at School of Traditional Iranian Medicine of Shahid Beheshti University of Medical Sciences
Category
Treatment - Drugs
2
Description
Control group: placebo syrup /each 12 hours 10cc for 6 weeks/ the syrups will be provided at School of Traditional Iranian Medicine of Shahid Beheshti University of Medical Sciences
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Babak Hoseini
Street address
Abiverdi, Chamran Ave
City
Shiraz
Province
Fars
Postal code
71946-34786
Phone
+98 71 3647 9531
Email
Hafez@sums.ac.ir
2
Recruitment center
Name of recruitment center
Shoushtari hospital
Full name of responsible person
Mohammad Afarid
Street address
Enghelab (Nader) Ave.
City
Shiraz
Province
Fars
Postal code
7173775617
Phone
+98 71 3232 4806
Email
shoushtari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Nyayesh intersection, Valiasre Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Mojtahedi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Niayesh Intersection,Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8877 0061
Fax
Email
mahboobemojtahedi72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnaz Tork Zahrani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nyayesh Intersection,Valiasre Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
zahranishahnaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Mojtahedi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nyayesh Intersection,Valiasre Ave
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0098 88770061
Fax
Email
Mojtahedi.mahboobe@sbmu.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document