This study investigated the effect of betamethasone on respiratory distress syndrome among neonates with gestational age of 35-36 weeks. Methods: This study was a double blind randomized controlled trial. Pregnant women who were high risk for preterm labor in 35-36 weeks of gestation were evaluated in Besat hospital of Sanandaj city. The intervention and placebo groups were received intramuscularly betamethasone and normal saline, respectively and they were compared for percent of newborns with respiratory distress syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901193666N1
Registration date:2010-05-17, 1389/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-17, 1389/02/27
Registrant information
Name
Majid Mansoury
Name of organization / entity
Kurdistan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1324 7594
Email address
dr_m_mansory@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of medical sciences
Expected recruitment start date
2006-01-21, 1384/11/01
Expected recruitment end date
2007-03-19, 1385/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of antenatal betamethasone on prevention of respiratory distress syndrome among neonates with gestational age of 35-36weeks
Public title
Effect of antenatal betamethasone on prevention of respiratory distress syndrome among neonates with gestational age of 35-36weeks
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women who were high risk for preterm labor in 35-36 weeks of gestation. Exclusion criteria: labor after week 37, Hypertension, Diabetes, Drug abuser, Anomaly in newborn, PROM.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of medical sciences
Street address
Kurdistan university of medical sciences, Pasdaran Ave
City
Sanandaj
Postal code
Approval date
2006-12-26, 1385/10/05
Ethics committee reference number
4644پ14پ
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
respiratory distress syndrome
Timepoint
one time
Method of measurement
clinical examination and CT scan
Secondary outcomes
1
Description
Brain hemorrhage
Timepoint
one time
Method of measurement
clinical examination and CT scan
Intervention groups
1
Description
intramuscularly betamethasone
Category
Prevention
2
Description
intramuscularly normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Majid Mansouri
Street address
Keshavarz Ave
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of medical sciences
Full name of responsible person
Dr. Heidary
Street address
Pasdaran Ave
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of medical sciences
Full name of responsible person
Majid Mansoury
Position
Assistant Prof.
Other areas of specialty/work
Street address
Besat Hospital
City
Sanandaj
Postal code
Phone
+98 87 1324 7594
Fax
Email
magidmansoori@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of medical sciences
Full name of responsible person
Majid Mansoury
Position
Assistant Prof.
Other areas of specialty/work
Street address
Keshavarz Ave, Besat Hospital
City
Sanandaj
Postal code
Phone
+98 87 1324 7594
Fax
Email
magidmansoori@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of medical sciences
Full name of responsible person
Majid Mansoury
Position
Assistant Prof.
Other areas of specialty/work
Street address
Keshavarz Ave, Besat hospital
City
Sanandaj
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)