Aim:
To determine the effect of corticosteroid, antibiotic and tocolytic in patient with PPROM on neonalal outecome .
Inclusion Criteria: PPROM, gestational ages 34-28 weeks, Live fetus
Exclusion criteria medical complications in the mother , abnormal fetal heart rate patterns, fetal anomalies
Population: pregnant women
Sample size: 64 person
Intervention study: In case group received magnesium sulfate intravenously 20 percent for 48 hours. two doses of 12 mg betamethasone within 24 hours intramuscular Ampicillin 2 gr every 6 hours for 48 hours
and Controls group just received Ampicillin 2 gr every 6 hours for 48 hours
Time: gestational ages 34-28 weeks
Primary outcomes: Upgar score
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105226558N1
Registration date:2011-07-07, 1390/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-07, 1390/04/16
Registrant information
Name
Aghdas Karimi
Name of organization / entity
Bums
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 0550
Email address
karimi_a2381@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2007-06-27, 1386/04/06
Expected recruitment end date
2009-03-16, 1387/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Corticosteroid, Antibiotic and Tocolytic in patient with PPROM (28-32 week) on neonalal outecome
Public title
The Effect of Corticosteroid, Antibiotic and Tocolytic on neonalal outecome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: PPROM in gestational ages 34-28 weeks, Live fetus
Exclusion criteria medical complications in the mother , imminent delivery,receiving antibiotics One week before admission to hospital or need to prescribe antibiotics after admission, , abnormal fetal heart rate patterns, fetal anomalies and other factors require termination of pregnancy and labor induction in maternal and fetal
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
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
birjand university of medical sience
Street address
Iran- South Khorasan- Birjand - St. Ghafari- Birjand University of Medical Sciences
City
birjand-
Postal code
Approval date
2007-06-25, 1386/04/04
Ethics committee reference number
443
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Neonatal outcome
Timepoint
48h
Method of measurement
questioner
Secondary outcomes
1
Description
Apgar score
Timepoint
After Birth
Method of measurement
questioner
Intervention groups
1
Description
Magnesium sulfate intravenously 20 percent for 48 hours.
Category
Treatment - Drugs
2
Description
two doses of 12 mg betamethasone within 24 hours intramuscular
Category
Treatment - Drugs
3
Description
Ampicillin 2 gr every 6 hours for 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of Medical Sience
Full name of responsible person
Street address
Iran- South Khorasa - Birjand - St. Ghafari- Birjand University of Medical Sciences
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mr Aahmadi
Street address
Birjand University of Medical Sciences, Ghafari St. , Birjand, South Khorasan
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Mahboobeh Zangooei
Position
Assistant Professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari St. , Birjand, South Khorasan
City
Birjand
Postal code
Phone
+98 56 1444 3045
Fax
Email
zahkarimy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University Of Medical Sciences
Full name of responsible person
Dr Mahboobeh Zngooei
Position
Assistant Professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari St. , Birjand, South Khorasan
City
Birjand
Postal code
Phone
+98 56 1444 3046
Fax
Email
zahkarimy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Aghdas Karimi
Position
Academic Member
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari St. , Birjand, South Khorasan
City
Birjand
Postal code
Phone
+98 56 1444 3047
Fax
Email
karimi_midwife@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)