The aim of this study was to compare the effects of magnesium sulfate with Phenytoin for seizure control in pregnant women with preeclampsia and eclampsia .This randomized, double-blind, single center study wasl conducted in Arash women’s hospital. Among singleton pregnant women in the third trimester, 400 of them were participated in this study. Inclusion criteria: preeclampsia (blood pressure >=140/90 and proteinuria) or eclampsia . Participants randomly assigned to two groups. Group I: 4 gram of magnesium sulfate in 100 cc Ringer ,IV, within 15 to 20 minutes. Then, 2 g in 100 cc serum ringer intravenously injected per hour. Group II: 750 mg of phenytoin in 100 cc Ringer intravenously and then table phenytoin 125 mg ,TDS . The two groups were given treatment up to 24 hours after delivery, and if the seizure was ocured,continues for up to 24 hours after seizure. And two groups in terms of seizures and seizure frequency during 48 hours of delivery was assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120311020N7
Registration date:2016-12-15, 1395/09/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-15, 1395/09/25
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of Medical sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparision of magnesium sulfate and Phenytoin on eclampsia seizure in pregnant women with preeclampsia and eclampsia
Public title
A comparision of magnesium sulfate and Phenytoin on eclampsia seizure in pregnant women with preeclampsia and eclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: moderate or sever preeclampsia or eclampsia
Exclusion criteria: twines pregnancy, history of hypertension or medical disease, history of seizure and neorology problems, smoking and alcohol consumption.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Tehran University of Medical Science
Street address
Dr Masoud Younesian
City
Tehran
Postal code
Approval date
1999-06-02, 1378/03/12
Ethics committee reference number
516
Health conditions studied
1
Description of health condition studied
Seizures
ICD-10 code
O15.2 O15
ICD-10 code description
Eclampsia in the puerperium, Eclampsia in labour
Primary outcomes
1
Description
Seizures
Timepoint
During 48 hours after delivery
Method of measurement
Observation
Secondary outcomes
1
Description
Apgar score
Timepoint
1 minute after delivery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group 1: 4 gram of magnesium sulfate in 100 cc Ringer ,IV, within 15 to 20 minutes. Then, 2 g in 100 cc serum ringer intravenously injected per hour.
Category
Treatment - Drugs
2
Description
Group II: 750 mg of phenytoin in100 cc Ringer intravenously and then table phenytoin 125 mg ,TDS
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Maryam Khoshideh
Street address
Arash women hospital, Rashid street, Resalat highway,Tehranpars
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ethics committee of Tehran University of Medical Science
Full name of responsible person
Dr. Masoud Younesian
Street address
Qods street, Keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ethics committee of Tehran University of Medical Science