Comparison of Lasix with Methyl Dopa in Control of Postpartum Blood Pressure in Preeclamptic Patients after Magnesium Sulfate Treatment in ICU of Akbar Abadi Hospital
Design
120 patients with severe preeclampsia who have given birth and are receiving magnesium sulfate and have a blood pressure of between 140.90 and 100.160, randomly assigned to a methyldopa group and to another group of lasagers And the effect of these two drugs on blood pressure control was compared in the first 24 hours after the intervention and 24 hours after the intervention and then one week later.
Settings and conduct
Single blind randomized clinical trials in the ICU ward of Akbar Abadi Hospital such that patients with severe preeclampsia who have given birth are receiving magnesium sulfate and have a blood pressure of between 140.90 and 100.160, The randomized trial is given to a group of Methyl Diphtheria and to another group of Lasix drugs and the patients dont know about wich drug (Intervention) they receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria included preeclampsia and magnesium sulfate, and lack of blood pressure control, with a blood pressure of between 140/90 to 160/100؛ Non-inclusion criteria including complications such as gestational diabetes, heart disease, kidney disease, And drug susceptibility to lasics and methyl dopa.
Intervention groups
First intervention group: Patients with preeclampsia and blood pressure of between 140/90 to 160/100 that treated by magnesium sulfate and methyl dopa.
Second intervention group: Patients with preeclampsia and blood pressure of between 140/90 to 160/100 that treated by magnesium sulfate and lasix.
Main outcome variables
Systolic blood pressure, Diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038349N1
Registration date:2018-05-24, 1397/03/03
Registration timing:retrospective
Last update:2018-05-24, 1397/03/03
Update count:0
Registration date
2018-05-24, 1397/03/03
Registrant information
Name
Setareh siahmansoori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4452 4857
Email address
siahmansoori.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2017-08-16, 1396/05/25
Actual recruitment end date
2018-02-26, 1396/12/07
Trial completion date
empty
Scientific title
comparison of lasix with methyldopa in control of postpartum hypertention in treated preeclamptic patients by Mgso4
Public title
comparison of lasix with methyldopa in control of postpartum hypertention in treated preeclamptic patients by Mgso4
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with preeclampsia.
Patient has been treated by Mgso4
The patient's blood pressure is between 140/90 to 160/100.
Exclusion criteria:
Patient has gestational diabetes.
Patient has heart disease.
Patient has renal disease.
Patient has allergic reaction to lasix.
Patient has allergic reaction to methyldopa.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are no longer aware of the Methyldopa or Lasix recipes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Akbarabadi Hospital., Mowlavi Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.IUMS.FMD.REC1396.9311290009
Health conditions studied
1
Description of health condition studied
Severe preeclampsia in postpartum patients
ICD-10 code
O14.1
ICD-10 code description
Severe pre-eclampsia
Primary outcomes
1
Description
The measure of patient's Systolic blood pressure that should be between 140 to 160 mm Hg.
Timepoint
Blood pressure measurement in the first 24 hours after the intervention and in the second 24 hours after the intervention, and then a week later
Method of measurement
Mercury barometric device
2
Description
The measure of patient's diastolic blood pressure that should be between 90 to 100 mm Hg.
Timepoint
Blood pressure measurement in the first 24 hours after the intervention and in the second 24 hours after the intervention, and then a week later
Method of measurement
Mercury barometric device
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: 250 mg methyl dopamine 250 mg every 8 hours manufactured by Zahravi Pharmaceutical Company for up to one week
Category
Treatment - Drugs
2
Description
Second Intervention group: 40 mg lasica 40 mg with a dose of 20 mg every 12 hours made by Sanofi Pharmacies partner for up to 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Setareh Siahmansoori
Street address
Akbar abadi Hospital., Mowlavi Ave
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
setareh.s.mansoori@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Iran University of Medical Sciences., Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 89701
Email
PR@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/page/26765
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran university of medical sience
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Setareh Siahmansoori
Position
Obstetric/Gynaecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.7, 9th alley., Tehransar Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
33318_4565
Phone
+98 21 4452 4857
Fax
Email
siahmansoori.s@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Setareh Siahmansoori
Position
OB/GYN resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7, 9th alley, Tehransar Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
33318_4565
Phone
+98 21 4452 4857
Fax
Email
siahmansoori.s@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Setareh Siahmansoori
Position
OB/GYN resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7, 9th alley, Tehransar Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
33318_4565
Phone
+98 21 4452 4857
Fax
Email
siahmansoori.s@tak.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available