This is a randomized, double-blind single-center trial with placebo. The aim of this study is to assess the magnesium sulfate effect on the frequency of epilepsy and cesarean section in women with mild pre- eclampsia in comparison with placebo. Our sample size is 500. All patients with mild preeclampsia are enrolled in study and women with sever preeclampsia, underlying diseases and previous caesarean section are excluded from study. In the first group, 4 grams of magnesium sulfate of 50% solution in 200 cc ringer serum is infused during 20 minuets and then 2 grams magnesium sulfate per hour is injected intravenously and continued up to 24 hours after delivery. In the second group distilled water is infused the same as the first group dosage. Then, seizure and cesarean delivery rates in both groups were compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052111020N5
Registration date:2016-10-27, 1395/08/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-27, 1395/08/06
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
Zahedan University of Medical Sciences
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the magnesium sulfate effect on the frequency of epilepsy and cesarean section in women with pre- eclampsia
Public title
Effect of magnesium sulfate on the rate of epilepsy and cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: mild pre- eclampsia; blood pressure between 130-90/ 150-105 mmhg/ mild protein urea
Exclusion criteria: sever pre- eclampsia; blurred vision; sever protein urea; oligurea; impaired liver enzyme; previous cesarean
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
500
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
Ethic committee of Zahedan Uviversity of Medical Sciences
Street address
Khlije Fars boulevard, Zahedan
City
Zahedan
Postal code
Approval date
2007-11-26, 1386/09/05
Ethics committee reference number
1926-86
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
O14.0
ICD-10 code description
Gestational Moderate pre-eclampsia
Primary outcomes
1
Description
Epilepcy
Timepoint
After delivery up to 24 hours
Method of measurement
Observational
2
Description
Cesarean section
Timepoint
During delivery
Method of measurement
Observational
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 4 grams of magnesium sulfate of 50% solution in 200 cc ringer serum is infused during 20 minuets and then 2 grams magnesium sulfate per hour is injected intravenously and continued up to 24 hours after delivery.
Category
Treatment - Drugs
2
Description
Control group: Distilled water is infused the same as the first group dosage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitleb Hospital
Full name of responsible person
Dr. Maryam Khooshide
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hooshang Rafighdoost
Street address
Zahedan University of Medical Sciences, Khalij Fars boulevard
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Zahedan 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
Zahedan Uviversity of Medical Sciences
Full name of responsible person
Dr.Maryam Khooshide
Position
women specialist
Other areas of specialty/work
Street address
Zahedan Uviversity of Medical Sciences, Khlije Fars boulevard
City
Zahedan
Postal code
Phone
+98 54 3339 5796
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Dr.maryam Khooshide
Position
women specialist
Other areas of specialty/work
Street address
Zahedan Uviversity of Medical Sciences, Khlije Fars boulevard
City
Zahedan
Postal code
Phone
+98 54 3339 5796
Fax
Email
khooshide@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. maryam Khooshide
Position
women specialist
Other areas of specialty/work
Street address
Zahedan Uviversity of Medical Sciences, Khlije Fars boulevard
City
Zahedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)