To determine he effect of fenugreek on milk volume and prolactin level in mothers of premature infants
Design
A concealed, randomized, triple blind, controlled clinical trial with a parallel group design of 68 women, phase 3.
Settings and conduct
This study will be performed on 68 postpartum mothers whose preterm delivery is under 32 weeks and whose infants are hospitalized in Al-Zahra and Taleghani educational and medical centers in Tabriz. Mothers will be assessed according to the eligibility criteria and if they have criteria and have willingness to participate in the study, the written informed consent will obtained and primary evaluations will be conducted. Participants will be assigned into two groups of fenugreek capsule recipient and placebo recipient
using block randomization method with block sizes of 4 and 6 and allocation ratio of 1:1.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with preterm infants under 32 weeks on the fifth day after delivery, Ability to breastfeed
Exclusion criteria: Allergy to fenugreek, Asthma disease, Endocrine problems
Intervention groups
The intervention group will receive a capsule containing 500 mg of fenugreek powder and the control group will receive a placebo capsule with the same dose three times a day for two weeks.
Main outcome variables
The main outcome variables are milk volume and prolactin level.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N62
Registration date:2021-01-24, 1399/11/05
Registration timing:prospective
Last update:2021-01-24, 1399/11/05
Update count:0
Registration date
2021-01-24, 1399/11/05
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-28, 1399/11/09
Expected recruitment end date
2021-05-30, 1400/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fenugreek on milk volume and prolactin level in mothers of premature infants: A randomized controlled clinical trial
Public title
The effect of fenugreek on milk volume and prolactin level in mothers of premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with preterm infants under 32 weeks on the fifth day after delivery
Having a minimum literacy
Ability to visit the mother of the hospitalized infant on a daily basis
Ability to breastfeed
Exclusion criteria:
Allergy to fenugreek
Any abnormalities in growth or breast surgery
Endocrine problems such as diabetes or thyroid disorder
Participate in other interventional study
Having asthma
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to two groups (one group receiving of oral fenugreek capsule three times a day for two weeks and one group receiving placebo with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1 and using the website www.random.org . To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer, and the drug and placebo will be placed in the same packages numbered sequentially.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
Placebo
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
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-01-17, 1399/10/28
Ethics committee reference number
IR.TBZMED.REC.1399.946
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Milk volume
Timepoint
7 days after the start of the intervention and 1 day after the end of the intervention
Method of measurement
Using the pump
2
Description
Serum prolactin levels
Timepoint
One day after the intervention
Method of measurement
Blood test
Secondary outcomes
1
Description
Infant weight
Timepoint
One day after the intervention
Method of measurement
Scale
2
Description
Satisfaction of mothers
Timepoint
One day after the intervention
Method of measurement
Checklist
3
Description
Exclusive breastfeeding
Timepoint
One day after the intervention
Method of measurement
Checklist
Intervention groups
1
Description
The intervention group will receive oral capsules containing 500 mg fenugreek powder three times a day (One tablet each time with breakfast, lunch and dinner) made by Pharmacy school of Tabriz University of Medical Sciences. The duration of treatment will be two weeks.
Category
Treatment - Drugs
2
Description
The control group will receive oral capsules containing 500 mg starch three times a day (One tablet each time with breakfast, lunch and dinner) made by Pharmacy school of Tabriz University of Medical Sciences. The duration of treatment will be two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Maryam Vaezi
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
mahsa.rouhi.mid@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
mahsa.rouhi.mid@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
Mahsa Rouhi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
mshsa.rouhi.mid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghfourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3478 5229
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghfourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3478 5229
Email
mirghafourvandm@tbzmed.ac.ir
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
Participant data is confidential .
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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