Comparison the effect of Descurainia sophia and placebo consumed by the mother in the last 6 weeks of pregnancy with Placebo on total and direct bilirubin levels in cord blood
The last 6 weeks of pregnancy
The aim of this study will be detection the effect of taking the Descurainna Sophia by mother in last 6 weeks of gestation on total and direct billirubin in cord blood. Inclusion criteria will include nulliparity and having a diploma or higher and exclusion criteria will include the incompatibility of RH, history of hemolysis in Parents and G6PD deficiency. The total sample size will be 100 women and 50 people in each group. At week 34 of pregnancy all subjects will complete the personal information form and then they will be randomely allocated to receive Descurainna Sophia or placebo from 34 weeks of gestation until time of delivery . The case group will receive 10 grams of Daphnia in a glass of water with sugar twice a day and the control group will receive only water and sugar . After birth the amount of total and direct bilirubin levels in cord blood will be measured with cord blood sampling and comapared in the two groups. The primary outcome will be total and direct bilirubin levels in cord blood.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405253078N11
Registration date:2014-08-07, 1393/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-07, 1393/05/16
Registrant information
Name
Masoumeh Delaram
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
mdelaram@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council in Shahrekord University of Medical Sciences
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Descurainia sophia and placebo consumed by the mother in the last 6 weeks of pregnancy with Placebo on total and direct bilirubin levels in cord blood
The last 6 weeks of pregnancy
Public title
The effect of Descurainia Sophia on neonatal jaundice
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Nulliparity; having a diploma or higher
Exclusion criteria : Incompatibility of RH; familial history of hemolysis in parents; G6PD difitiency
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Shahrekord, Iran.
City
Shahrekord
Postal code
3343588138
Approval date
2014-06-04, 1393/03/14
Ethics committee reference number
-
Health conditions studied
1
Description of health condition studied
Neonatal Jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Total bilirubin levels in cord blood
Timepoint
At Birth
Method of measurement
Cord blood samplying
2
Description
Direct bilirubin levels in cord blood
Timepoint
At Birth
Method of measurement
Cord blood samplying
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will recieve 10 grams of Descurainia sophia in 250 cc of water and sugar twice a day from 34 weeks of gestation to time of delivery. After birth, the amount of total and direct bilirubin will detect by samplying of cord blood.
Category
Prevention
2
Description
The control group will receive a placebo (250 cc water and sugar) twice a day from 34 weeks of gestation to time of delivery. After birth, the amount of total and direct bilirubin levels in cord blood will be measured .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers and Hajar Hospital in Shahrekord
Full name of responsible person
Masoumeh Delaram
Street address
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Street address
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.
City
Shahrekord
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.com
Web page address
http://www.skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.com
Web page address
http://www.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.
City
Shahrekord
Postal code
8813833435
Phone
+98 38133356458
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.com
Web page address
http://www.skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)