This study aimed to investigate the effect of magnesium sulfate in infants of mothers with premature rupture of membranes Intraventricular hemorrhage. After confirming the inclusion criteria and obtain the written consent of the individual, individuals one of two groups assigned. Patients were randomly assigned into two groups used of “ran between “order in Excel software and in order to hide the sealed envelopes. Inclusion criteria including, who are have signed a consent form, gestational age 34 weeks, lack of Hypertension, lack of Pre-eclampsia, lack of congenital malformations. Beside the conventional treatments, the intravenous magnesium sulfate will administer in intervention group with dose of 6 gram during 20 to 30 minutes before labor. In comparison group only conventional treatments plus normal saline infusion will using. Finally the neonates in both groups will assessing for intraventricular hemorrhage (IVH) and if necessary the cranial ultrasonography will requested. The sample size this study is 120.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080729223N1
Registration date:2016-10-03, 1395/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-03, 1395/07/12
Registrant information
Name
Mahsa Rezaei
Name of organization / entity
Iran University of medical Science
Country
Iran (Islamic Republic of)
Phone
+98 66509283
Email address
rezaei.mah@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-06-01, 1394/03/11
Expected recruitment end date
2016-02-01, 1394/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of Magnesium Sulfate in Prevention of Intraventricular Hemorrhage in Premature Infants: Randomization Clinical Trial
Public title
The survey of Magnesium Sulfate in Prevention of Intraventricular Hemorrhage in Premature Infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: who are have signed a consent form; Gestational age 34 weeks; Lack of Hypertension; Lack of Pre-eclampsia; Lack of congenital malformations.
Exclusion criteria: Lack of consent for enter the study; having hypertension; having pre-eclampsia; having congenital malformations.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Science
Street address
Iran, Tehran, Hemat Highway, Milad Tower
City
Tehran
Postal code
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
IR.IUMS.rec.1394.9111290015
Health conditions studied
1
Description of health condition studied
Premature Infants
ICD-10 code
P01.1
ICD-10 code description
Fetus and newborn affected by premature rupture of membranes
Primary outcomes
1
Description
Intraventricular Hemorrhage
Timepoint
After the birth
Method of measurement
Cranial Ultrasonically
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous Magnesium Sulfate with dose of 6 gram during 20 to 30 minutes
Category
Prevention
2
Description
Comparison group:
without drug
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Dr. Mahsa Rezaei
Street address
Ferdos s; Molavi st; Tehran; Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Javad Musavi
Street address
Vice chancellor for research, Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahsa Rezaei
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av; Sattar khan st; Tehran; Iran
City
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
mahasa.rezaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Mahsa Rezaei
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av; Sattar khan st; Tehran; Iran
City
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
mahasa.rezaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mahsa Rezaei
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Niayesh Av. Sattar khan St. Tehran, Iran.
City
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
mahasa.rezaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)