The efficacy of pomegranate and plum pastes used in the last three months of pregnancy on exacerbated physiological neonatal jaundice in newborns: a double-blinded clinical trial
The efficacy of pomegranate and plum pastes used in the last month of pregnancy on exacerbated physiological neonatal jaundice in newborns in Afzalipour hospital, Kerman
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Random sequence was used in SAS software for randomization.
Settings and conduct
The place of study is Afzalipour Hospital. Women in the 34th week of pregnancy are divided into 3 groups. A group receiving pomegranate paste in the last trimester of pregnancy, a group receiving plum paste in the last trimester of pregnancy, and the control group did not receive any treatment. The participants and the researcher who evaluates the results are unaware of the random allocation of participants.
Participants/Inclusion and exclusion criteria
Women in the 34th week of pregnancy, with a minimum age of 18 years and a maximum age of 35 years without a history of diseases such as hypertension, gestational diabetes and hypothyroidism.
Intervention groups
One group will receive pomegranate paste in the last trimester of pregnancy and one group will receive plum paste in the last trimester of pregnancy
Main outcome variables
Serum bilirubin level, frequency of receiving phototherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221023056271N1
Registration date:2022-12-05, 1401/09/14
Registration timing:prospective
Last update:2022-12-05, 1401/09/14
Update count:0
Registration date
2022-12-05, 1401/09/14
Registrant information
Name
Maryam Dalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8000
Email address
mar_dalili@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of pomegranate and plum pastes used in the last three months of pregnancy on exacerbated physiological neonatal jaundice in newborns: a double-blinded clinical trial
Public title
The efficacy of pomegranate and plum pastes used in jaunsice
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Maximum age is 35 years
Exclusion criteria:
Mothers with gestational diabetes
Mothers with hypertension
Mothers with hypothyroidism
History of severe jaundice in the last born baby
History of blood transfusion in the last born baby
Mothers with blood group O
History of G6PD in last born baby
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use a random sequence created with SAS statistical software, women participating in the study will be divided into 3 groups based on the order of entering the hospital to receive services. Also, with the help of sealed transparent envelopes, random allocation will be concealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The pomegranate and plum pastes are presented to participants in both intervention groups in cloudy and nameless jars, and due to the similar taste of both substances, it is not possible to differentiate for the participants. Also, the researcher who collects, analyzes, and interprets the data does not know about allocation randomization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ethics committee of Kerman University of Medical Sciences, Afzalipour hospital, Imam highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.KMU.AH.REC.1401.135
Health conditions studied
1
Description of health condition studied
Eٍxacerbated physiological neonatal jaundice in newborns
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Serum bilirubin level in newborns
Timepoint
Three days after birth
Method of measurement
Blood test
2
Description
Receive phototherapy
Timepoint
Three days after birth
Method of measurement
Doctor's diagnosis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pomegranate paste, women in this group, during the last month of pregnancy, use pomegranate paste at the rate of one tablespoon twice a day for one month. They use it before food.
Category
Prevention
2
Description
Intervention group: plum paste, women in this group, during the last month of pregnancy, take one tablespoon of plum paste twice a day for one month. They use it before food.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Maryam Dalili
Street address
Afzalipour hospital, Imam highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
mar_dalili@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Ebn-e Sina St., Vice-Chancellery for Research & Technology
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
malekpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Maryam Dalili
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipour hospital, Imam High way, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
Email
Mar_dalili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Dalili
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipour hospital, Imam High way, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
Email
Mar_dalili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Dalili
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipour hospital, Imam High way, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
Email
Mar_dalili@yahoo.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