Comparison of the effect of two treatments with magnesium sulfate in preeclampsia
Design
Clinical trial, with parallel, randomized groups, phase 3 on 120 patients with quadruple blockade that was analyzed with Spss software version 24.
Settings and conduct
In this study, 120 mothers with preeclampsia referred to the gynecology and obstetrics ward of Besat Hospital in Sanandaj are evaluated. These individuals are randomly divided into 12-hour intervention group and 24-hour control group treated with magnesium sulfate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Preeclampsia, 140/90 mm Hg or higher after 20 weeks of gestation, proteinuria with a plus or more
Conditions for not entering: Eclampsia, HELLP syndrome
Intervention groups
Patients with preeclampsia are randomly divided into intervention group (12-hour sulfate therapy regimen) and control group (24-hour sulfate therapy regimen).
Main outcome variables
Systolic blood pressure before intervention
Diastolic blood pressure before intervention
Systolic blood pressure after intervention
Diastolic blood pressure after intervention
Time to start breastfeeding
Time to start oral feeding
Foley catheter insertion time
Bedtime
Ability to breastfeed
Need to re-administer magnesium sulfate
Incidence of eclampsia
Side effects of magnesium sulfate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200503047287N1
Registration date:2020-09-02, 1399/06/12
Registration timing:prospective
Last update:2020-09-02, 1399/06/12
Update count:0
Registration date
2020-09-02, 1399/06/12
Registrant information
Name
Fatemeh Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 0264
Email address
amirh.brdrn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic regime of magnesium sulfate for 12-hours and 24-hours in postpartum severe preeclampsia
Public title
Comparison treatment of magnesium sulfate for 12-hours and 24-hours in preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preeclampsia
Blood pressure 140/90 mm Hg or higher after 20 weeks of gestation
Proteinuria with a rate of one plus or more
Exclusion criteria:
ٍEclampsia
HELLP Syndrome
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of individuals to intervention and control groups by quadruple randomization block method:
Pregnant mothers with preeclampsia referred to the obstetrics and gynecology ward of Besat Hospital Random assignment of individuals to the intervention and control group: Patients with preeclampsia randomly divided into the intervention group (12 hours) or the control group (24 hours) as follows: Patients are divided into two groups by forming four random blocks: group A (treatment with magnesium sulfate for 24 hours), group B (treatment with magnesium sulfate for 12 hours)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.MUK.REC.1399.016
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
High blood pressure
Timepoint
Hospitalization time and every one hour during magnesium sulfate treatment
Method of measurement
The patient's systolic and diastolic blood pressure is measured every hour by a standard sphygmomanometer.
Secondary outcomes
1
Description
Incidence of seizures: Incidence of involuntary repetitive movements, Complications of magnesium sulfate: which is assessed by spinal reflexes through the patellar reflex, assessment of the number of breaths per minute and the amount of urine collected in the urinbag
Timepoint
Urine output is measured every hour with a Foley catheter
Method of measurement
Using a Foley catheter
Intervention groups
1
Description
Control group: Group A is a control group that includes pregnant mothers with preeclampsia referred to the obstetrics and gynecology ward of Besat Hospital who are being treated with 24-hour magnesium sulfate.
Category
Treatment - Drugs
2
Description
Intervention group: Group B is an intervention group that includes pregnant mothers with preeclampsia referred to the obstetrics and gynecology ward of Besat Hospital who are being treated with 12-hour magnesium sulfate.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Educational Hospital
Full name of responsible person
Nasrin Soofizadeh
Street address
Keshavarz St.
City
Sanandaj
Province
Kurdistan
Postal code
6619667761
Phone
+98 87 3320 0222
Email
besat@muk.ac.ir
Web page address
http://besat.muk.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Street address
Pasadaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4651
Email
info@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
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
Sanandaj University of Medical Sciences
Full name of responsible person
Fatemeh Farahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Padaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4651
Email
amirh.brdrn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fatemeh Farahani
Position
Reisdent
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4651
Email
amirh.brdrn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fatemeh Farahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Padaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4651
Email
amirh.brdrn@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the request of the journal that publishes the article, the data will be provided to the journal.
When the data will become available and for how long
At the time of publication of the article up to six months later
To whom data/document is available
Editor of the journal and academic researchers with the permission of the responsible author
Under which criteria data/document could be used
Only allowed to perform meta-analysis on data.
From where data/document is obtainable
By contacting the responsible author at amirh.brdrn@gmail.com
What processes are involved for a request to access data/document
The application should be sent to the e-mail of the responsible author by sending a resume and the purpose of achieving the research. After reviewing the application, information will be provided to them within a week.