Protocol summary

Summary
(1)Objectives: The objectives of this study is to evaluate the effect of silymarin on hepatic and platelet disorders in pregnant women with severe pre-eclampsia. (2)Design: this randomized double-blind study is to carry out on two groups of 30 women with severe preeclampsia. (3)Setting And Conducts:having entered the study, patients’ data and previous testing including the blood pressure, liver tests and platelet count are to extract from their history and is recorded in related lists. Both groups of patients are to undergo routine treatment for severe pre-eclampsia, including magnesium sulfate and hydralazine. In the intervention group, 3 and 24 hours after the termination of pregnancy, 70 mg silymarin is to be administered orally. In the control group at the same times, placebo is to be administered. Liver enzymes, LDH uric acid , direct Bilirubin, Total Bilirubin, ALP, ALT, AST, Cr, BUN, and urinary proteinuria and platelet count is to be repeated 12 , 36 and 60 hours after drug administration. Finally, two groups are to be compared in terms of blood pressure, proteinuria, liver enzyme levels and platelet counts. (4)Participants: Inclusion criteria included termination of pregnancy due to severe preeclampsia, gestational age of 35 to 42 weeks at the time of pregnancy termination, absence of other diseases. (5)Intervention: Administration of 70 mg of silymarin in the intervention group and administration of placebo in the control group 3 and 24 hours after termination of pregnancy. (6)Main outcome masure:the number of platelets, AST, ALT, LDH

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090423887N1
Registration date: 2015-11-10, 1394/08/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-11-10, 1394/08/19
Registrant information
Name
Fahime Kave baghbahadorani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 5751
Email address
kave@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University Of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of silimaryn in improvement of hepatic and platlet damage in severe preeclampsia
Public title
Evaluation the effect of silimaryn in improvement of hepatic and platlet damage in severe preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 and 30 years; BMI is to be 20 to 24;Gestational age is between 35 and 42 weeks at the time of termination of pregnancy; blood pressure before the termination of pregnancy is to be more than 90/140 mm Hg;The presence of Proteinuria in random urine samples before pregnancy termination; no history of hypertension, diabetes, kidney disease, Collagen vascular and other types of cardiovascular diseases; mother is supposed to be nulliparous; Singleton pregnancy not molar; termination of pregnancy is indicated By severe pre-eclampsia Exclusion criteria:presence of preeclampsia in mother
Age
From 20 years old to 30 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord, Iran
City
Shahrekord
Postal code
Approval date
2014-01-12, 1392/10/22
Ethics committee reference number
92-10-13

Health conditions studied

1

Description of health condition studied
preeclampsia
ICD-10 code
XV14
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria

Primary outcomes

1

Description
platlet count
Timepoint
0,12,36 and 60 hours after intervention
Method of measurement
count in mm3

2

Description
blood pressure
Timepoint
q 3 hours in study
Method of measurement
mmHg

3

Description
liver enzyme
Timepoint
before and 12,36 and 60 hours after trial
Method of measurement
labratoary kit

Secondary outcomes

1

Description
number of blood pressure crisis in study
Timepoint
q 3 hours
Method of measurement
bp >160/110 mmhg

Intervention groups

1

Description
In the intervention group, 3 and 24 hours after newborn birth, 70 mg of silymarin is to be orally administered to mother.
Category
Treatment - Drugs

2

Description
In the control group, 3 and 24 hours after birth, placebo is to be administered to the mother.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Hajar Hospital
Full name of responsible person
Fahime Kaveh bagh bahadorani
Street address
Hajar Hospital, Parastar Street, Shahrekord, Iran
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Dr Mahmoud Rafiyan
Street address
Shahrekord University Of Medical Sciences, Rahmatie, 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
Dr Sepide Miraj
Position
Atend
Other areas of specialty/work
Street address
Hajar Hospital, Parastar Street, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
miraj@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Dr Sepide Miraj
Position
Obstetric And Gynecologist
Other areas of specialty/work
Street address
Hajar Hospital, Parastar Street, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
miraj@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord Univrsity Of Medical Sciences
Full name of responsible person
Fahime Kave baghbahadorani
Position
Resident Of Gynecology
Other areas of specialty/work
Street address
Hajar Hospital, Parastar Street, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
fahim.kaveh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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