Determination of neuroprotective effects of magnesium sulfate on preterm infants with a gestational age of 32-36 weeks
Design
This study was designed as a randomized, phase 3 clinical trial with a control group and a sample size of 246 and with parallel groups.
Settings and conduct
This study will be carried out at Arash Hospital on pregnant women who have been hospitalized due to spontaneous preterm labor.
First, informed consent will be obtained from patients, then demographic, pregnancy and medical questionnaires will be completed. participants will randomly be divided into two groups.: the first group will receive magnesium sulfate and the second group will receive routine care.
Type of delivery, gestational age at delivery, neonatal outcomes such as 1 and 5 min Apgar score, respiratory distress, neonatal intensive care unit (NICU) admission, and seizure were recorded. Neurodevelopment will be assessed at the age of four, six, eight, ten, and twelve months using the Ages & Stages Questionnaires (ASQ) questionnaires. These questionnaires will be partially completed by parents and partly by physicians.
Participants/Inclusion and exclusion criteria
All women with spontaneous preterm delivery at the age of 36-32 weeks of gestation will be included and in a case of maternal diseases or fetal abnormalities will be excluded.
Intervention groups
Intervention group: Intravenous infusion of Magnesium sulfate 50%, 2 g per hour for 12 hours
Control group: Routine cares (including fetal heart rate monitoring and control of labore progress)
Main outcome variables
Neonatal Neuromotor Development
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120826010664N5
Registration date:2019-12-26, 1398/10/05
Registration timing:registered_while_recruiting
Last update:2019-12-26, 1398/10/05
Update count:0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Reihaneh Pirjani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3288
Email address
pirjani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of neuroprotective effects of magnesium sulfate on preterm infants with a gestational age of 32-36 weeks
Public title
Magnesium sulfate neuroprotection in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy
Spontaneous labor
Gestational age between 32 and 36 weeks
Exclusion criteria:
Maternal underlying diseases
Fetal abnormalities
Intrauterine growth retardation (IUGR)
Contraindications for use of magnesium sulfate
Iatrogenic preterm birth
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
246
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method was designed by Stata version 13 software by the epidemiologist. The number of blocks considered is 6. To conceal the random allocation process, 100 treatment cards will be written in sequential order, then the cards will be placed in sealed envelopes. On each envelope, a random 10-digit code will be written with no sequences and a framework that identifies the relevant patient, and only the methodologist will be aware of the code. When the physician announces a patient's eligibility, the methodologist will provide the envelope with the physician, and the treatment will be selected based on the code written in the envelope.
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 Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods Streetو Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-11-24, 1398/09/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.607
Health conditions studied
1
Description of health condition studied
Infant immaturity
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Neurodevelopmental status of infants (including APGAR score, Arterial blood pH after the birth, and Neurodevelopment status after the age of 4 months)
Timepoint
0, 4, 6, 8, 10, and 12 months after the birth
Method of measurement
Blood test and standard Ages & Stages Questionnaires (ASQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One time Intravenous infusion of Magnesium sulfate (made in pasteur institute co, Tehran, Iran) 50% diluted in Ringer lactate serum at a dose of 2 g per hour for 12 hours
Category
Treatment - Drugs
2
Description
Control group: Without intervention (Receiving routine cares including only control of labor progress and fetal heart rate monitoring)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr Reyhaneh Pirjani
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
pirjani@Razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Tehran University of Medical Science, Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Saeideh Zndi
Position
Obstetrics and Gynecology Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3288
Fax
+98 21 7788 3196
Email
s.zandi2020@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reihaneh Pirjani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3288
Fax
+98 21 7788 3196
Email
pirjani@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reihaneh Pirjani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3288
Fax
+98 21 7788 3196
Email
pirjani@razi.tums.ac.ir
Web page address
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