Effect of antenatal prophylactic betamethasone injection on neonatal respiratory distress syndrome reduction in multifetal pregnancies
Design
The clinical trial included a control group without betamethasone and one intervention group receiving betamethasone 12 mg muscular, study is one- blinded.Groups are parallel.Patients will be randomly assigned to two intervention and control groups using a random number table based on the case number.
Settings and conduct
This study will be done about effect of antenatal prophylactic betamethasone injection on neonatal respiratory distress syndrome reduction in multifetal pregnancies.All mothers encoded in both groups will be included in the study and evaluated, and the person evaluating the occurrence of respiratory syndrome will be unaware of how to group and receive the beta-methasone of the mother, and the study will be done blinded.
Participants/Inclusion and exclusion criteria
Entrance criteria: Mothers with multiple pregnancies under 28 weeks
Non-compliance criteria: A mother's disease that restricts the administration of corticosteroids.
Intervention groups
Intervention group 1: Betamethasone ampoule (manufactured in Iran), 12 mg Muscular, 24 hours apart, will be injected into two doses between the weeks of gestation 28-26.
Control group: Group without betamethasone
Main outcome variables
Neonatal respiratory distress syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038879N1
Registration date:2018-03-10, 1396/12/19
Registration timing:registered_while_recruiting
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Fatemeh Abbasalizadehf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
abbasalizadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-05, 1396/11/16
Expected recruitment end date
2019-09-07, 1398/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of antenatal prophylactic betamethasone injection on neonatal respiratory distress syndrome reduction in multifetal pregnancies
Public title
Effect of antenatal prophylactic betamethasone injection on neonatal respiratory distress syndrome reduction in multifetal pregnancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple pregnancy less than 28 weeks
Exclusion criteria:
Dissatisfaction patient to participate in this study.
Motherhood disease that limits the administration of corticosteroids.
Multifetal pregnancies that has another risk factor for early childbirth.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with using a random number table based on the case number, will be randomly assigned into two intervention and control groups
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 Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2018-02-13, 1396/11/24
Ethics committee reference number
IR.TBZMED.REC.1396.1000
Health conditions studied
1
Description of health condition studied
حاملگی چند قلویی
ICD-10 code
Z35.4
ICD-10 code description
Supervision of multiparity pregnancy
Primary outcomes
1
Description
Neonatal respiratory distress syndrome
Timepoint
Immediately after birth
Method of measurement
Newborn clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Betamethasone ampoule (manufactured in Iran), 12 mg(Intramuscular injection) per 24 hours, will be injected into two doses between the weeks of gestation 28-26.
Category
Treatment - Drugs
2
Description
Control group: Group without receive betamethasone
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Fatemeh Abbasalizadeh
Street address
Alzahra Hospital, South Artesh St.
City
Tabiz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
خیابان گلگشت- ساختمان مرکزی شماره دو-طبقه سوم
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Abbasalizadeh
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Abbasalizadeh
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Abbasalizadeh
Position
Professor Obstetricians and Gynecologists
Latest degree
Subspecialist
Other areas of specialty/work
Prenatologist
Street address
Golgasht Street; Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
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