1-Determination and comparison of serum prolactin levels in nursing mothers before intervention and 14 days after taking medication. 2- Determining the weight of neonates participating in the study at the birthday, day 14 and day 28
Design
Three arm parallel group with 50 people, randomized trial with double-blinded
Settings and conduct
The serum levels of prolactin in nursing mothers at the beginning of the study and before taking drugs in Imam Sajjad Hospital in Yasuj, and 14 days after taking medications, were measured by ELISA method using Probind PRL kit (ELISA) from Saman Tajhiz Noor Co. from the blood sample. Will be recorded.
The weight gain of the baby, which is an indirect indication of the amount of breast milk, is measured by weighing the infant at birth, on the 14th and 28th day after birth, with a Seca725 digital scanner with a precision of 5g. Will be recorded. The changes in serum prolactin and the weight gain of the baby will be compared in these three groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1.Mothers with newborn babies
2.No contraindication for breastfeeding
3.Healthy baby
4.No having a history of cardiovascular disease in the mother
5.Obtain informed and written consent of patients
6.Birth weight exceeding 2500 grams
Non-inclusion criteria:
1.Mother's unwillingness to continue lactation
2.Significant side effects
Intervention groups
1- Domperidone consumer group
2- Fennel powder consumer group
3- The placebo group
Main outcome variables
Mother's age, Newborn sex, Prolactin serum level of the mother, Newborn weight
Type of delivery, Number of deliveries, Consumable medicine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161103030684N2
Registration date:2019-05-09, 1398/02/19
Registration timing:retrospective
Last update:2019-05-09, 1398/02/19
Update count:0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 000
Email address
keshtkari@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fennel powder on serum prolactin in nursing mothers and weight gain in newborns with the effect of domperidone and placebo
Public title
The effect of fennel powder on serum prolactin levels in nursing mothers and newborns weight gain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers have a newborn baby
No contraindication for breast feeding
Well baby
Not having a history of cardiovascular disease in the mother
Obtain informed and written consent of patients
Birth weight, more than 2500 grams
Exclusion criteria:
Age
From 1 day old to 2 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation was done with the help of lottery so that the number of people in three groups of intervention and control of the paper was inscribed with the name of the group and placed in a container and by referring each patient one paper randomly selected and the person to the group Written in the paper.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is done single blind. This means that only patients who received the medication did not know.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasuj Research Ethic Committee
Street address
Blvd shahid mothahari ,Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.YUMS.REC.1397.002
Health conditions studied
1
Description of health condition studied
Comparison the effect of Foeniculum Vulgare Miller ( Fennel) on serum prolacin and newborn weight gain with the effect of Domperidone and placebo
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mother blood serum of prolactin. a weight of newborn,
Timepoint
A blood sample of mothers were taken before and 14 days after using the above drugs. The birth weight, weight of the 14th day and the 28th day were measured.
Method of measurement
blood serum levels of prolactin were measured in the laboratory. weight measured using digital scales
Secondary outcomes
1
Description
New born weight gain
Timepoint
At birth, 14 day and 28 day after birth
Method of measurement
By digital scale
2
Description
Change in prolactin level
Timepoint
Before taking of drug , 2 weeks later
Method of measurement
By labratory
Intervention groups
1
Description
Intervention group:After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of 1th group received the capsule containing domperidone for 14 days and the level of serum prolactin before and after from the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales.
Category
Treatment - Drugs
2
Description
Intervention group: After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of 2nd group received the capsule containing fennel powder for 14 days and the level of serum prolactin before and after From the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales.
Category
Treatment - Drugs
3
Description
Control group: After explaining the different stages of the study by the program administrators and obtaining voluntary consent from the volunteers without any costs for medicine, examination or visitation, patients of this group received the placebo capsule for 14 days and the level of serum prolactin before and after from the 14th day of taking the above medicine, blood samples were taken from them and blood serum was sent to the laboratory. The newborn weight at the birth time, the 14th day and the twenty-eighth day was measured using digital scales.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam sajjad hospital of yasuj
Full name of responsible person
Ali keshtkari
Street address
Shahid jalil Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 0163
Email
a_keshtkari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali keshtkari
Street address
Shahid Motahari Blvd,yasuj medical scienese
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
a_keshtkari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Ali keshtkari
Position
assistant profesor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid motahatri Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
a_keshtkari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali keshtkari
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
pediatric gastroentrologist
Street address
Shahid motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
a_keshtkari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali keshtkari
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
a_keshtkari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD