The aim of this study is comparison of betamethasone with dexametasone on amniotic fluid index,inclusion criteria is pregnant women with gestational age of 28wk -32wk at risk of preterm labor,exclusion criteria is gestational diabet mellitus in pregnant women or high blood sugar in pregnant women, every systemic disease in mother, every high blood pressure in mother, every vaginal leak in mother, small gestational age or intra uterine growth retardation, consumption of any drug in mother except supplementation, all case studies are pregnant women with gestational age 28wk - 32wk of 75 women. these 75 women are divided into two groups. In the first group dexamethasone is used while in the second group betamethasone is used. It is noted that before and three days after consumption of these drugs in each group, Amniotic Fluid Index (AFI) and Non Stress Test (NST) are performed and the increase or decrease of Amniotic Fluid Index (AFI) and changes in Non Stress Test (NST) are taken into consideration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212307513N2
Registration date:2013-12-27, 1392/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-27, 1392/10/06
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Esfahan University of Medical Science
Expected recruitment start date
2011-06-01, 1390/03/11
Expected recruitment end date
2014-06-02, 1393/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between betamethasone and dexamethasone on biophysical profile
Public title
A comparison between betamethasone and dexamethasone on biophysical profile in 28wk - 32wk pregnant women at risk of preterm labor
Purpose
Treatment
Inclusion/Exclusion criteria
EXCLUSION :1:having diabet mellitus & rising blood pressure and consumption of drug except supplement and small for gestational age fetus & anomaly in fetus & premature rupture of membrane
INCLUSION:1:pregnant woman 28wk-34wk with at least once preterm labor in her past medical history or at risk of preterm labor
Age
From 16 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Etical committee of medical scienceof esfahan
Street address
Hezar jarib st
City
Esfahan
Postal code
20212-45678
Approval date
2011-03-06, 1389/12/15
Ethics committee reference number
389484
Health conditions studied
1
Description of health condition studied
preterm labor
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
biophisical profile
Timepoint
befor &after corticosteroide adminstration
Method of measurement
sonography
Secondary outcomes
1
Description
sonography biophysical profile and non stress test
Timepoint
3 days after administration of corticosteroides in each group
Method of measurement
sonography and non stress test
Intervention groups
1
Description
Group 1: betamethasone 12 mg per day at most 2 doses.
Category
Treatment - Drugs
2
Description
Group 2: Dexamethasone 8 mg in each 12 hours at most 4 doses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hosital
Full name of responsible person
Hatav GHasemi Tehrani
Street address
Alzahra hospital
City
Isfahan
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
zahra komrani
Street address
Esfahan,beheshti hospital
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Science
Full name of responsible person
Hatav GHasemi Tehrani
Street address
Alzahra Hospital
City
Isfahan
Grant name
-
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Science
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
beheshti hospital
Full name of responsible person
zahra komrani
Position
obstetric resident
Other areas of specialty/work
Street address
Beheshti hospital, Felezi bridge, Esfahan, Iran.
City
esfahan
Postal code
81848-51153
Phone
+98 31 1236 7001
Fax
Email
zkomran@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
beheshti hospital
Full name of responsible person
dr ghasemi tehrani
Position
specialist in obstetric and gynecology
Other areas of specialty/work
Street address
Beheshti hospital, Felezi bridge, Esfahan, Iran.
City
esfahan
Postal code
81848-51153
Phone
+98 31 1236 7001
Fax
Email
tehrani@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
beheshti hospital
Full name of responsible person
zahra komrani
Position
obstetric and gynecology resident
Other areas of specialty/work
Street address
isfahan
City
Beheshti hospital, Felezi bridge, Esfahan, Iran.
Postal code
81848-51153
Phone
+98 31 1236 7001
Fax
Email
zkomran@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)