Aims: Determining the Effectiveness of Nutritional Measures in Pregnant Women in Prevention of Neonatal Hyperbilirubinemia
Design: Single blind interventional study (Only the participants)
Setting and conduct: 80 pregnant women will be placed in equal numbers in two intervention and control groups. All of them should be healthy and free from underlying diseases (diabetes, high blood pressure and hypothyroidism) and give birth to healthy babies. The nutrition plan will be given to the intervention group. The neonatal blood bilirubin level will be measured 5 days after birth with bilirubin test.
Major Inclusion criteria: Nulliparous pregnant women whose labor can be natural or Cesarean section; mothers with uncomplicated pregnancies; No history of systemic and chronic disease; willingness to cooperate in the study.
Major Exclusion criteria: preterm delivery; complications of pregnancy such as gestational diabetes, pre eclampsia and hypothyroidism and high blood pressure; birth weight less than 2.5 or more than 4 kg; newborn infant with birth defects; less than 8 Apgar score; pathological jaundice.
Interventions: (1) intervention group: not to use hot foods such as peppers, garlic, nuts, red meat and yolks from the 34th week of pregnancy + using cold foods such as yogurt, dough, lettuce, cucumber and watermelon if they feel warm in their body.
(2) control group: No action.
Main outcome measure: Jaundice in newborns
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017050933475N2
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Mohsen Manouchehrian
Name of organization / entity
Shahid Sadoughi Univercity
Country
Iran (Islamic Republic of)
Phone
+98 21 4432 8882
Email address
m.manouchehrian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of pregnant women's nutritional modification on neonatal jaundice
Public title
Interventional study of evaluating the effect of pregnant women's nutritional modification on neonatal jaundice
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous pregnant women whose labor can be natural or Cesarean section; mothers with uncomplicated pregnancies; No history of systemic and chronic disease; willingness to cooperate in the study.
Exclusion criteria: preterm delivery; complications of pregnancy such as gestational diabetes, pre eclampsia and hypothyroidism and high blood pressure; birth weight less than 2.5 or more than 4 kg; newborn infant with birth defects; less than 8 Apgar score; pathological jaundice.
Ethics committee of Iran University of Medical Sciences
Street address
Next to the Milad Tower, Hemmat Highway
City
Tehran
Postal code
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.IUMS.REC 1395.95-03-208-29326
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy
Primary outcomes
1
Description
The occurrence of jaundice
Timepoint
4 days after birth
Method of measurement
Bilirubin Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: not to use hot foods such as peppers, garlic, nuts, red meat and yolks from the 34th week of pregnancy + using cold foods such as yogurt, dough, lettuce, cucumber and watermelon if they feel warm in their body
Category
Prevention
2
Description
Control group:
No action
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Dr. Mohsen Manouchehrian
Street address
Akbar Abadi Hospital, Bagh Ferdos station, Molavi street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Malakooti
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Center of Akbar Abadi Hospital
Full name of responsible person
Dr. Mohsen Manouchehrian
Position
Resident of Traditional Medicine
Other areas of specialty/work
Street address
Akbar Abadi Hospital, Bagh Ferdos Station, Molavi Street.
City
Tehran
Postal code
Phone
+98 21 5560 6034
Fax
Email
m_manouchehrian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reseach Center of Akbar Abadi Hospital
Full name of responsible person
Dr. Mohsen Manouchehrian
Position
Resident of Traditional Medicine
Other areas of specialty/work
Street address
Akbar Abadi Hospital, Bagh Ferdos Station, Molavi Street.
City
Tehran
Postal code
Phone
+98 21 5560 6034
Fax
Email
m_manouchehrian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center of Akbar Abadi Hospital
Full name of responsible person
Dr. Mohsen Manouchehrian
Position
Resident of Traditional Medicine
Other areas of specialty/work
Street address
Akbar Abadi Hospital, Bagh Ferdos Station, Molavi Street.
City
Tehran
Postal code
Phone
+98 21 5560 6034
Fax
Email
m_manouchehrian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)